Researchers at the Greifswald teaching hospital in northern Germany said Friday they’ve discovered how the AstraZeneca COVID vaccine could cause blood clots that could lead to rare thrombosis in the brain, public broadcaster Norddeutscher Rundfunk reported.

The German team, led by professor Andreas Greinacher, said in a statement that AstraZeneca’s vaccine may, in some cases, prompt overactivation of platelets in the blood, which can lead to potentially deadly clots. As NPR reported, Greinacher said it’s similar to what happens with a condition called heparin-induced thrombocytopenia.

Greinacher and his team analyzed 13 cases of cerebral blood clots reported in Germany within 4 – 16 days of administration of the AstraZeneca vaccine. Twelve of the 13 cases were women and almost all were under the age of 55. In four of the 12 patients, the team was able to isolate and identify the specific antibodies that provoked the immune reaction leading to the cerebral blood clots.

The researchers found that AstraZeneca’s vaccine activates blood platelets, or thrombocytes, which typically only happens in the body when a wound is healing — when the blood coagulates as the wound closes. In some patients, the vaccination activated a mechanism that caused blood clots to form in the brain, according to Deutsche Welle.

Experts hope the discovery could lead to targeted treatment for those who suffer similar clotting. But researchers emphasized that treatment would help only after the blood clot appeared — it wouldn’t prevent the clot from occurring.

More than 20 countries have either suspended or said they will delay vaccinations of the Oxford-AstraZeneca vaccine following reports of deaths or injuries — in most cases related to blood clots — in healthy people who received the vaccine.

Prosecutors in Northern Italy announced Monday they had seized a batch of 393,600 shots of the AstraZeneca COVID vaccine following the death of a 57-year-old man hours after he was vaccinated, reported Reuters. 

Meanwhile the World Health Organization (WHO) is standing firm in its support of the vaccine. In a press conference today, WHO Director General Tedros Adhanom Ghebreyesus said, “This does not necessarily mean these events [deaths and injuries] are linked to the vaccine, but it’s routine practice to investigate them, and it shows that the surveillance system works and effective controls are in place.”

According to news reports, WHO’s vaccine safety experts were meeting today to discuss the vaccine. WHO had previously said that an ongoing analysis by its vaccines advisory committee has not established a causal link between the vaccine and blood clots and countries should keep using it, reported The Telegraph

Regulators in Europe also defended the vaccine telling news outlets that the “benefits outweigh the risks.” Still, the European Medicines Agency (EMA) is investigating reports of blood clots in vaccine recipients and will release its findings Thursday, according to Nasdaq.com. 

39-Year-Old Woman Dies 4 Days After Second Moderna Vaccine, Autopsy Ordered

The Defender reported:

A 39-year-old woman from Ogden, Utah, died Feb. 5, four days after receiving a second dose of Moderna’s COVID vaccine, according to CBS affiliate KUTV.

Kassidi Kurill died of organ failure after her liver, heart and kidneys shut down. She had no known medical issues or pre-existing conditions, family members said.

KUTV uncovered the death as part of its investigation into COVID vaccine side effects. The investigation involved looking into reports submitted by Utah residents to the Vaccine Adverse Event Reporting System (VAERS).

According to The Salt Lake Tribune, there were four deaths in Utah reported to VAERS in January and February, including Kurill’s.

KUTV reported that doctors at Intermountain Medical Center recommended Kurill’s family request an autopsy, and the family agreed.

The medical examiner could not say whether the autopsy would be automatically forwarded to the Centers for Disease Control and Prevention (CDC) and U.S Food and Drug Administration (FDA).

Dr. Erik Christensen, Utah’s chief medical examiner, said proving vaccine injury as a cause of death almost never happens. “Did the vaccine cause this? I think that would be very hard to demonstrate in autopsy,” Christensen told KUTV.

***

February 23

Fauci’s Mixed Messages, Inconsistencies About COVID-19 Masks, Vaccines and Reopenings Come Under Scrutiny

Fox News reported:

Another issue on which Fauci has adjusted his stances is on exactly what level of vaccination is necessary for the U.S. to reach herd immunity to the virus. Fauci previously said the percentage of Americans who need to be vaccinated to reach that goal was 70% before revising that number up to higher than 80%.

This inspired a story in the New York Times that accused Fauci of “quietly shifting” recommendations. Fauci then explained to the paper that he was taking public opinion polls into account in how he shaped his comments.

“When polls said only about half of all Americans would take a vaccine, I was saying herd immunity would take 70 to 75%,” Fauci said, according to the paper. “Then, when newer surveys said 60% or more would take it, I thought, ‘I can nudge this up a bit,’ so I went to 80, 85.”

Health Officials Push Pregnant Women to Get COVID Shots, Despite Known Risks

The Defender reported:

In December, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to two messenger RNA (mRNA) vaccines against COVID-19. Because the unapproved vaccines’ status is investigational, anyone who gets an injection (whether they realize it or not) is agreeing to participate in an ongoing experiment.

Recognizing that there are many unknowns, many Americans have refused the experimental jab, including members of the armed forces and healthcare workers, but with one notable exception: healthcare providers who are pregnant.

Even without data from Pfizer or Moderna sufficient “to inform vaccine-associated risks in pregnancy,” expectant doctors, nurses and others appear eager for the shots, perhaps influenced by the American College of Obstetricians and Gynecologists, which states that neither a conversation with a clinician nor even a pregnancy test are necessary prerequisites.

Do these individuals know that as of Feb. 12, the Vaccine Adverse Event Reporting System (VAERS) had already received 111 reports of adverse events experienced by women who were pregnant at the time of their Pfizer or Moderna injection?

FDA Says COVID Vaccines That Target New Variants Won’t Need Large Clinical Trials to Win Approval

CNBC reported:

The U.S. Food and Drug Administration said Monday that modified COVID-19 vaccines against new, emerging variants may be authorized without the need for lengthy clinical trials.

The new guidance, released in a 24-page document on the FDA’s website, would clear the new vaccines as an amendment to a company’s originally approved emergency use application, according to the FDA. The company would need to submit new data that shows the modified vaccine produces a similar immune response and is safe, similar to the process for annual flu vaccines.

“Preliminary reports from clinical trials evaluating COVID-19 vaccine candidates in multiple countries including South Africa have added to concerns that vaccine efficacy against the B.1.351 variant may be lower than against the original virus,” the agency wrote in the document, referring to the strain found in South Africa. “Thus, there is an urgent need to initiate development and evaluation of vaccines against these SARSCoV-2 variants.”

The updated guidance comes as U.S. health officials, including White House Chief Medical Advisor Dr. Anthony Fauci, are concerned the virus potentially could mutate enough to evade the protection of current vaccines and reverse the progress made on the pandemic.

Pfizer Eyes Higher Prices for COVID-19 Vaccine After the Pandemic Wanes: Exec, Analyst

FiercePharma reported:

Amid the high-stakes fight against COVID-19, a company at the forefront of the vaccine effort is laying plans to hike prices after the crisis. A top Pfizer exec said the drugmaker aims to charge more after the “pandemic pricing environment,” and an influential analyst says the company could be eying prices 3 to 4 times higher.

On an earnings call earlier this month, CFO Frank D’Amelio said that “obviously,” the company is “going to get more on price” after the “pandemic pricing environment.” He was speaking in response to Bank of America Merrill Lynch analyst Jason Zemansky, who asked the management team about how profit margins for the program could change over time.

In short, D’Amelio explained that Pfizer expects its COVID vaccine margins to improve. Under one pandemic supply deal, Pfizer is charging the U.S. $19.50 per dose, D’Amelio said, which is “not a normal price like we typically get for a vaccine—$150, $175 per dose. So, pandemic pricing.”

Can People on Blood Thinners Get the COVID Vaccine?

Newsweek reported:

Clot Connect, a blood clot information service run by the University of Carolina’s Blood Research Center, states “patients should not avoid the COVID vaccination because they are on a blood thinner.”

In addition, Clot Connect said people who receive a COVID vaccine do not need to interrupt their blood thinner.

According to the U.K.-based charity the British Heart Foundation (BHF) it is “in general” safe for people taking anticoagulant blood thinners such as warfarin to take the vaccine, but that they should let their vaccine provider know they are on the medication.

The charity said: “If you are taking a blood thinner such as warfarin, or a new anticoagulant, the bleeding may take a little longer to stop and you may get more bruising on your upper arm.”

According to the North American Thrombosis Forum (NATF), “global recommendations state that you can be vaccinated if your anticoagulation is stable” but those who take the anticoagulant medication warfarin should routinely test their INR levels, which help determine blood clotting.

It’s Not Clear That We Actually Need Human Challenge Trials for COVID-19, but the UK Is Moving Ahead With Them Anyway

TIME reported:

On Feb. 17, health officials in the UK announced that they are ready to start exposing healthy volunteers to the COVID-19 virus in a carefully controlled study. The so-called human challenge trial is the first of its kind for COVID-19 and will help scientists learn how much virus is needed to cause infection, among other important questions.

The practice of intentionally exposing healthy people to a disease-causing (and potentially deadly) pathogen isn’t new in science, but it remains controversial. Scientists must balance the benefits of exposing people—which mostly fall in the realm of new knowledge about the microbe in question and the disease it causes—against the risks of infection and disease. Human challenge trials are especially useful when time is of the essence, and researchers want to quickly test a new drug or vaccine, for example, and can’t wait for a threshold of people to get naturally infected. In those cases, the intentional exposure speeds up the time to getting critical answers about whether a potential new treatment or vaccine works.

That was the justification for considering human challenge trials a few months ago to study COVID-19 vaccines. But as COVID-19 case counts continued to rise over the holidays around the world, most vaccine makers quickly reached the number of cases they needed to analyze the effectiveness of their shots. Plus, there are now several vaccines authorized as safe and effective, so the immediate mandate for quickly developing a vaccine has waned. “We are no longer in the mode of, let’s accelerate the approval process for vaccines,” says Dr. Ezekiel Emanuel, chair of medical ethics and health policy at the University of Pennsylvania. “So the exact justification for [human challenge trials] I think is harder to come by.”

FDA Issues Updated Guidance on Adapting COVID-19 Vaccines, Tests and Therapeutics for Coronavirus Variants

CNN Health reported:

The U.S. Food and Drug Administration has issued updated guidance for companies that plan to adapt their COVID-19 medical products — including vaccines, tests and therapeutics — to address the emergence of coronavirus variants.

The agency said in an announcement on Monday that it expects that “manufacturing information will remain generally the same” for authorized COVID-19 vaccines that may be updated to target variants. The agency recommended that data from clinical immunogenicity studies be used to support any changes or updates to vaccines.

Such studies would be smaller and could take less time than large-scale clinical trials.

FDA Advisers To Consider EUA Recommendation for Single-dose Johnson & Johnson COVID-19 Vaccine This Week

KCTV5 News reported:

Vaccine advisers to the U.S. Food and Drug Administration will meet Friday to discuss whether to recommend Johnson & Johnson’s COVID-19 vaccine for emergency use authorization.

The vaccine is the third under consideration for the U.S. market, and would be the first single-dose COVID-19 shot available here. Like the earlier COVID-19 vaccines, it was developed and tested at a remarkable pace, condensing into months what might have taken years before the pandemic.

But there are few answers on what will happen if and when it is authorized. The White House said Monday it has not made any plans yet for distributing the vaccine if it wins authorization. There are vague totals of how many doses will be available immediately and no word on exactly where those doses will go.

The Biden administration said last week that, if it is authorized, there are probably single-digit millions of doses available in coming weeks. On Tuesday, Johnson & Johnson’s Dr. Richard Nettles will say that the plan “is to begin shipping immediately upon emergency use authorization, and deliver enough single-doses by the end of March to enable the vaccination of more than 20 million Americans,” according to prepared remarks to be delivered before a House Committee on Energy & Commerce subcommittee.

Why Does the Pandemic Seem to Be Hitting Some Countries Harder Than Others?

The New Yorker reported:

After the pandemic was declared, last March, epidemiologists expected carnage in such areas. If the fatality rate from the “New York wave” of the pandemic were extrapolated, between three thousand and five thousand people would be expected to die in Dharavi. With Joshi’s help, Mumbai’s municipal government set up a field hospital with a couple of hundred beds, and doctors steeled themselves to working in shifts. Yet by mid-fall Dharavi had only a few hundred reported deaths—a tenth of what was expected—and the municipal government announced plans to pack up the field hospital there. By late December, reports of new deaths were infrequent.

I was struck by the contrast with my own hospital, in New York, where nurses and doctors were prepping I.C.U.s for a second wave of the pandemic. In Los Angeles, emergency rooms were filled with stretchers, the corridors crammed with patients straining to breathe, while ambulances carrying patients circled outside hospitals.

And there lies an epidemiological mystery. The usual trend of death from infectious diseases—malaria, typhoid, diphtheria, H.I.V.—follows a dismal pattern. Lower-income countries are hardest hit, with high-income countries the least affected. But if you look at the pattern of COVID-19 deaths reported per capita—deaths, not infections—Belgium, Italy, Spain, the United States, and the United Kingdom are among the worst off. The reported death rate in India, which has 1.3 billion people and a rickety, ad-hoc public-health infrastructure, is roughly a tenth of what it is in the United States. In Nigeria, with a population of some two hundred million, the reported death rate is less than a hundredth of the U.S. rate. Rich countries, with sophisticated health-care systems, seem to have suffered the worst ravages of the infection. Death rates in poorer countries—particularly in South Asia and large swaths of sub-Saharan Africa—appear curiously low. (South Africa, which accounts for most of sub-Saharan Africa’s reported COVID-19 deaths, is an important exception.)

As the pandemic engulfed the world during the past several months, I kept returning to the question of what might explain these discrepancies. It was an epidemiological whodunnit. Was the “demographic structure” of a population the real factor? Were the disparities exaggerated by undercounting, with shoddy reporting systems hiding the real toll from public-health analysts? Was government response a critical variable? Or were other, less obvious factors at play? Perhaps any analysis would prove premature. If new viral strains, such as the South African variant of the virus, known as 501Y.V2, were to sweep through Africa, every prediction of mortality might be overturned. But as I started speaking with colleagues from around the world I found that my puzzlement was widely shared. For many statisticians, virologists, and public-health experts, the regional disparities in COVID-19 mortality represent the greatest conundrum of the pandemic.

***

February 22

Johns Hopkins Doctor Thinks COVID Will Be Largely Gone By April, Half of U.S. Has Herd Immunity

Newsweek reported:

Dr. Marty Makary, a surgeon and a professor at the Johns Hopkins School of Medicine and Bloomberg School of Public Health, believes that the coronavirus will be “mostly gone” by April.

In an op-ed published by The Wall Street Journal on Friday, Makary argued that half of the U.S. has already reached herd immunity because there are more coronavirus cases in the country, possibly 6.5 times as many, than the 28 million that have been reported.

Combined with the 15 percent of Americans who have already begun receiving the vaccine, the doctor argued that normal life will return by the spring.

“There is reason to think the country is racing toward an extremely low level of infection,” Makary wrote. “As more people have been infected, most of whom have mild or no symptoms, there are fewer Americans left to be infected. At the current trajectory, I expect COVID will be mostly gone by April, allowing Americans to resume normal life.”

Declining A COVID-19 Vaccine Risks Penalties In Some Countries

Washington Post reported:

Some countries are sharpening their COVID-19 vaccination pitches to the public: Get a shot or face a potential penalty.

With vaccination campaigns ramping up globally and some supply shortages easing, governments are looking for ways to make sure that holdouts don’t undermine efforts to vaccinate enough people to achieve herd immunity.

The penalties range from fines and restricting access to public places to threatening the loss of priority access to vaccines.

Indonesia has already levied fines for refusing vaccination of around $356—or more than a month’s salary on average, according to the country’s per capita gross domestic product.

Long-Term Studies Of COVID-19 Vaccines Hurt By Placebo Recipients Getting Immunized

NPR reported:

“During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.

“It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots.

Dr. Steven Goodman, a clinical trials specialist at Stanford University, says losing those control groups makes it more difficult to answer some important questions about COVID-19 vaccines.

Companies Pan for Marketing Gold in Vaccines We ran this already.

Kaiser Health News reported:

Among senior living facilities — which saw their largest drop in occupancy on record last year — some companies are marketing vaccinations to recruit residents. Sarah Ordover, owner of Assisted Living Locators Los Angeles, a referral agency, said many in her area are offering vaccines “as a sweetener” to prospective residents, sometimes if they agree to move in before a scheduled vaccination clinic.

Oakmont Senior Living, a high-end retirement community chain with 34 locations, primarily in California, has advertised “exclusive access” to the vaccines via social media and email. A call to action on social media reads: “Reserve your apartment home now to schedule your Vaccine Clinic appointment!”

Although the vaccine offer was a selling point for Crow, it wasn’t for her parents, who have not been concerned about contracting COVID and didn’t want to forgo their independence, she said. Ultimately, they moved in with her sister, who could arrange home care services.

The Next COVID-19 Vaccine Hurdle: Convincing Millions of Americans They Want the Shot

Vox reported:

In the coming months, America could reach a point when it has more COVID-19 vaccines than people want.

Between efforts from the federal government and drug companies to step up manufacturing and distribution, the US’s vaccine supply is truly increasing: At least 150 million doses are expected through March — a rate of more than 3 million shots a day, the kind of speed the country needs to reach herd immunity, when enough people are protected against the virus to stop its spread, this summer.

But public health experts are increasingly warning of what may come as America inches closer to the finish line in its vaccine campaign: After the majority of people who want a vaccine get one, there’s a large minority of people who have voiced skepticism in public surveys. And if these people don’t change their minds in the coming months, they could doom any chance the US has of reaching herd immunity.

Can I Choose My COVID Vaccine? Strong Opinions On Oxford Vs. Pfizer Emerge In UK.

Washington Post reported:

It’s the ultimate first-world problem. While more than 130 countries are still waiting for coronavirus vaccines, the wealthiest nations have doses on offer from multiple makers, and people rolling up their sleeves want to know: Can I choose which shot I get?

In Britain, the options today are the homegrown Oxford-AstraZeneca jab, “the English one,” or the Pfizer-BioNTech vaccine, “the posh one.” Doctors’ offices describe the phones ringing with patients certain which is better, or best, for them.

The choice is complicated by the fact that there is not supposed to be any choice. There is no private option in Britain for this. The vaccines are bought, distributed and deployed by the state-funded National Health Service, which serves all, rich and poor, free at the point of service — with no one allowed to jump the queue or pick and choose.

Entire Brazilian City Will Be Vaccinated Against COVID-19 In Giant Experiment

LiveScience reported:

An entire Brazilian city will be vaccinated against COVID-19 in a giant experiment to test whether the vaccines reduce the spread of the virus.

The city of Serrana in the state of São Paulo is home to about 30,000 adults who will all be offered a COVID-19 vaccine within the next three months as part of a research study run by the Butantan Institute in Brazil.

Everyone in the city over the age of 18 (except for pregnant or breastfeeding women and those with serious illnesses) will be offered the CoronaVac vaccine, developed by Chinese company Sinovac, CNN reported. The aim of the study, known as “Project S,” is to figure out whether the vaccine will reduce the spread of the virus.

People Who Have Had COVID Should Get Single Vaccine Dose, Studies Suggest

The New York Times reported:

The results of these new studies are consistent with the findings of two others published over the past few weeks. Taken together, the research suggests that people who have had COVID-19 should be immunized — but a single dose of the vaccine may be enough.

“I think it’s a really strong rationale for why people who were previously infected with COVID should be getting the vaccine,” said Jennifer Gommerman, an immunologist at the University of Toronto who was not involved in the new research.

A person’s immune response to a natural infection is highly variable. Most people make copious amounts of antibodies that persist for many months. But some people who had mild symptoms or no symptoms of COVID-19 produce few antibodies, which quickly fall to undetectable levels.

GSK and Sanofi Start With New COVID-19 Vaccine Study After Setback

Reuters reported:

GlaxoSmithKline and Sanofi on Monday said they had started a new clinical trial of their protein-based COVID-19 vaccine candidate, reviving their efforts against the pandemic after a setback in December delayed the shot’s launch.

The British and French drugmakers aim to reach final testing in the second quarter, and if the results are conclusive, hope to see the vaccine approved by the fourth quarter after having initially targeted the first half of this year.

In December, the two groups stunned investors when they said their vaccine would be delayed towards the end of 2021 after clinical trials showed an insufficient immune response in older people.

Australian Open Trophy Presentation Interrupted After Fans ‘Boo’ Mentions of the Coronavirus Vaccine

SBS News reported:

The Australian Open men’s final trophy presentation was marred by an “embarrassing” chorus of boos after the Tennis Australia president mentioned the rollout of the coronavirus vaccine, which kicked off on Sunday.

President Jayne Hrdlicka was forced to pause her speech on Sunday night due to the noise from the crowd, after she said it was time for hope and optimism after “deep loss and extraordinary sacrifice for everyone.”

“With vaccinations on the way, rolling out in many countries around the world, it’s now a time for optimism and hope for the future,” she said, before fans began booing.

The boos restarted later in her speech after she thanked the Victorian government for making the tournament possible.

***

February 19

A U.S. Vaccine Surge Is Coming, With Millions of Doses Promised

Bloomberg reported:

The U.S. vaccine supply is poised to double in the coming weeks and months, according to an analysis by Bloomberg, allowing a broad expansion of doses administered across the country.

Currently, the U.S. is administering 1.6 million doses a day, constrained by the recent supply of about 10 million to 15 million doses a week. But Covid-19 vaccine manufacturers and U.S. officials have accelerated their production timelines and signaled that the spigots are about to open, providing hundreds of millions of doses to match the growing capacity to immunize people at pharmacies and mass-vaccination sites.

A review of drugmakers’ public statements and their supply deals suggests that the number of vaccines delivered should rise to almost 20 million a week in March, more than 25 million a week in April and May, and over 30 million a week June. By summer, it would be enough to give 4.5 million shots a day.

Bloomberg’s analysis is based on company and government statements, data on the number of shots already delivered and conversations with people familiar with the manufacturing effort who spoke on condition of anonymity. The analysis assumes drugmakers will meet their new delivery targets — not a guarantee in a year-old pandemic where much has gone wrong.

Latest VAERS COVID Vaccine Data Include Reports of Cardiac-Related Deaths and Anaphylactic Reactions

The Defender reported:

According to new data released today, as of Feb. 12, 15,923 adverse reactions to COVID vaccines, including 929 deaths, have been reported to the Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) since Dec. 14, 2020.

VAERS is the primary mechanism in the U.S. for reporting adverse vaccine reactions. Reports submitted to VAERS require further investigation before a determination can be made as to whether the reported adverse event was directly or indirectly caused by the vaccine.

The latest VAERS data show that 799 of the deaths were reported in the U.S., and that about one-third of those deaths occurred within 48 hours of the individual receiving the vaccination.

As is consistent with previous VAERS data reports, 192 of the reported deaths — or 21% — were cardiac-related. As The Defender reported earlier this month, Dr. J. Patrick Whelan, a pediatric rheumatologist, warned the U.S. Food and Drug Administration in December that mRNA vaccines like those developed by Pfizer and Moderna could cause heart attacks and other injuries in ways not assessed in safety trials.

Of the 929 deaths reported since Dec. 14, 2020, the average age of the deceased was 77.8 and the youngest was 23. Fifty-two percent of the reported deaths were among men, 45% were women and 3% are unknown. Fifty-eight percent of the deaths were reported in people who received the Pfizer vaccine, and 41% were related to the Moderna vaccine.

States with the highest reported number of deaths were: California (71); Florida (50); Ohio (38); New York (31); Kentucky (41); Michigan (31); and Texas (31).

Entire Brazilian City Will Be Vaccinated Against COVID-19 in Giant Experiment

Live Science reported:

An entire Brazilian city will be vaccinated against COVID-19 in a giant experiment to test whether the vaccines reduce the spread of the virus.

The city of Serrana in the state of São Paulo is home to about 30,000 adults who will all be offered a COVID-19 vaccine within the next three months as part of a research study run by the Butantan Institute in Brazil. 

Everyone in the city over the age of 18 (except for pregnant or breastfeeding women and those with serious illnesses) will be offered the CoronaVac vaccine, developed by Chinese company Sinovac, CNN reported. The aim of the study, known as “Project S,” is to figure out whether the vaccine will reduce the spread of the virus.

UK Will Infect Healthy Young People With COVID in World’s First Human Challenge Trial

The Defender reported:

The UK announced Wednesday that it will be the first country to run human challenge trials on COVID-19, a type of study that requires deliberately infecting healthy people with the potentially deadly virus.

The controversial study — the first of its kind on COVID — is geared toward understanding the virus, testing the effectiveness of current vaccines and accelerating development of newer vaccines, according to a UK government press release.

Proponents of the strategy say it’s about saving lives by speeding up development of vaccines and understanding the virus. According to The New York Times, scientists and bioethicists say the risk of coronavirus “seriously sickening or killing young, healthy volunteers — the sort of people who would be infected — is low enough as to be outweighed by the possibility of saving tens of thousands of lives.”

But critics of human challenge trials suggest that infecting healthy people with a potentially deadly virus, for which there is no cure, is unethical.

In an op-ed published in November, by the Proceedings of the National Academy of Sciences (PNAS), five medical experts said moving forward with human challenge studies on COVID-19 is unethical.

They wrote:

“Whereas proponents of these studies suggest that such studies will accelerate the time to approve vaccines, the facts fail to support these claims. HCS to address SARS-CoV-2 face unacceptable ethics challenges, and, further, undertaking them would do a disservice to the public by undermining already strained confidence in the vaccine development process.”

So far, thousands of volunteers have signed up for the UK’s COVID human challenge trials through 1 Day Sooner, a U.S. advocacy group that “lobbies for challenge trials to accelerate vaccine development.”

Pfizer to Begin COVID Vaccine Clinical Trial in Pregnant Women

NBC News reported:

Pfizer-BioNTech said Thursday that it is beginning clinical trials of its COVID-19 vaccine in pregnant women, the first such trials to include expectant mothers in the U.S.

The drugmaker aims to enroll about 4,000 pregnant women in the trials, which will include participants in the U.S. as well as Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain and the U.K. Women over 18 and who are 24 to 34 weeks into their pregnancy will be eligible.

The first doses will be administered in the U.S., Pfizer said.

Dr. Brenna Hughes, a maternal-fetal medicine specialist at Duke Health in Durham, North Carolina, said she “absolutely applauds” Pfizer’s study of its vaccine in pregnant women.

Orlando Pediatric Center Begins COVID-19 Vaccine Trials for Children

WKMG reported:

The first trials of the Moderna COVID-19 vaccine clinical trials for children 12 to 17 years old began at Orlando’s Nona Pediatrics Center.

“I feel fine. My shoulder is a little sore just cause of the vaccine, but that’s it,” said Bella Truxall, 16, after she received the first of two doses.

Truxall is an avid volleyball player and frequently goes on tournament trips, which she said played a major factor in her decision to be part of this trial.

“Being around a bunch of people, going to volleyball tournaments; we go to Tampa, Orlando, Georgia, so there’s just a lot of people around,” Truxall said.

It was a significant day for her mother, Rachel, who encouraged her to be part of the trial and drove from Port Orange to Orlando with her.

Some Retirement Communities Lure New Residents With Promise of COVID-19 Vaccines

NBC News reported:

For a decade, Jennifer Crow has taken care of her elderly parents, who have multiple sclerosis. After her father had a stroke in December, the family got serious in its conversations with a retirement community — and learned that one service it offered was COVID-19 vaccination.

“They mentioned it like it was an amenity, like ‘We have a swimming pool and a vaccination program,’” said Crow, a librarian in southern Maryland. “It was definitely appealing to me.”

Vaccines, she felt, would help ease her concerns about whether a congregate living situation would be safe for her parents, and for her to visit them; she has lupus, an autoimmune condition.

As the coronavirus death toll soars and demand for the COVID-19 vaccines dwarfs supply, an army of hospitals, clinics, pharmacies and long-term care facilities has been tasked with getting shots into arms. Some are also using that role to attract new business — the latest reminder that health care, even amid a global pandemic, is a commercial endeavor where some see opportunities to be seized.

These Doctors Want to Pick Their COVID-19 Vaccine, Fearing Reactions, Lower Efficacy

The Wall Street Journal reported:

Health-worker unions in Europe say thousands of their members refuse to take one of the three COVID-19 vaccines available in the region because of concerns over efficacy and reports of side effects, the latest setback for the continent’s slow vaccine rollout.

Organizations representing health professionals across Europe said this week that doctors and nurses shouldn’t be forced to take the vaccine developed by AstraZeneca PLC because it was shown to offer less robust protection against COVID-19 than the other two currently authorized in the European Union. They also expressed concern over reports that the AstraZeneca vaccine appeared to cause stronger reactions in recipients.

Hospitals said hundreds of health professionals scheduled to get the vaccines hadn’t shown up for their appointments in recent days while many who had got the shot were calling in sick after reporting painful headaches, fever and other symptoms.

How Will Covax Deliver COVID-19 Vaccines to Poorer Countries?

The Wall Street Journal reported:

Developing countries are falling dangerously behind in the global race to end the coronavirus pandemic through vaccinations. The Covax facility aims to get COVID-19 shots to at least 20% of the populations of the world’s poorest nations.

What is Covax?

Covax is the world’s main effort for getting COVID-19 vaccines to poor countries. It was started last year by the World Health Organization and two groups that have been working on getting vaccines to developing countries—Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations—when it became clear that many nations would struggle to access the shots. As rich countries have done, Covax made deals with vaccine manufacturers to buy doses before they had passed clinical trials and been approved by drug regulators. The money to buy the vaccines has been donated mostly by Western governments and charitable groups, such as the Bill & Melinda Gates Foundation.

***

February 18

Many Top NBA Players Hesitant to Promote Coronavirus Vaccines

ESPN reported:

Many of the NBA’s top players are expressing apprehension about accepting invitations to participate in league-sponsored public service announcements to bolster broader acceptance of the coronavirus vaccine, sources told ESPN.

The NBA’s outreach to the agents of many of the league’s elite players — with hopes of getting stars to participate in PSAs to promote the safety and effectiveness of the vaccine  — has been met with a tepid response, sources said. Player apprehensions about receiving the vaccine are consistent with those that also exist in Black communities throughout the country, agents and players told ESPN.

Sources describe a number of factors contributing to many players’ reluctance to participate, including uncertainty about taking the vaccine themselves, reluctance to advocate its use for others and resistance to extending favors to a league amid the largely unpopular plans for an All-Star Game.

WHO Approves AstraZeneca Vaccine for Emergency Use, But Some Nations Say ‘No Thanks’

The Defender reported:

The World Health Organization (WHO) Monday approved two versions of the AstraZeneca-Oxford COVID vaccine for emergency use despite growing safety concerns in other countries and earlier questions about the drugmaker’s clinical trials.

Countries like the U.S., UK, Israel, Saudi Arabia and others have their own regulatory process for granting emergency use approval for vaccines and other drugs, but those countries that lack the necessary regulatory framework rely on WHO to vet vaccines.

WHO’s approval of the vaccines produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India paves the way for 300 million doses of AstraZeneca to reach 145 countries in the first half of 2021, through Bill Gates’ COVAX program.

But while WHO is moving forward, other countries are hitting pause on AstraZeneca amid ongoing reports of side effects and lack of efficacy.

 

No Jab, No Job: Vatican Gets Tough With COVID Anti-Vaxxers

Reuters reported:

The Vatican has told employees that they may risk losing their jobs if they refuse to get a COVID-19 vaccination without legitimate health reasons.

A decree by Cardinal Giuseppe Bertello, effectively the governor of Vatican City, said getting a vaccine was “the responsible choice” because of the risk of harming other people.

Vatican City, at 108 acres the world’s smallest state, has several thousand employees, most of whom live in Italy. Its vaccination programme began last month and Pope Francis, 84, was among the first to get the jab.

The seven-page decree says that those who cannot get vaccinated for health reasons may be given another position, presumably where they would have contact with fewer people, but will receive the same pay even if the new post is a demotion.

AstraZeneca Vaccine Faces Resistance in Europe After Health Workers Suffer Side-Effects

U.S. News & World Report reported:

Health authorities in some European countries are facing resistance to AstraZeneca’s COVID-19 vaccine after side-effects led hospital staff and other front-line workers to call in sick, putting extra strain on already-stretched services.

Such symptoms, as reported in clinical trials for the AstraZeneca shot, can include a high temperature or headache and are a normal sign that the body is generating an immune response. They usually fade within a day or so.

The other shots approved in Europe, developed by Pfizer and Moderna, have been linked to similar temporary side-effects, including fever and fatigue.

But with the AstraZeneca shot the latest to be rolled out, health authorities in France have issued guidance to stagger giving the shot, two regions in Sweden paused vaccinations, and in Germany some essential workers are refusing it.

Pfizer Study Deals New Blow to South Africa’s Vaccine Hopes

Reuters reported:

Scientists will meet on Thursday to advise South Africa’s government on its next steps after a study suggested the dominant local coronavirus variant may reduce antibody protection from Pfizer’s COVID-19 vaccine by two-thirds.

The laboratory study, published in the New England Journal of Medicine, dealt a new blow to the country hardest-hit by the pandemic on the African continent.

The government and its advisers must weigh whether to wait for vaccines that might be more effective against the more infectious 501Y.V2 variant, or try to vaccinate people quickly to avert further infections and deaths.

South Africa had been counting on the Pfizer shot, developed with German partner BioNTech, to step up its vaccination programme after administering the first Johnson & Johnson (J&J) doses on Wednesday.

Earlier this month, it placed AstraZeneca vaccinations on hold because of interim data showing its jab offered minimal protection against mild to moderate illness from the 501Y.V2 variant first identified late last year.

Facebook CEO Zuckerberg Expresses Concern About COVID-19 Vaccines in Leaked Footage

The Epoch Times reported:

Facebook CEO Mark Zuckerberg made comments last year about COVID-19 vaccines that clash with policies that his platform has implemented, leaked video shows.

Zuckerberg said in July 2020: “I do just want to make sure that I share some caution on this [vaccine] because we just don’t know the long-term side effects of basically modifying people’s DNA and RNA … basically the ability to produce those antibodies and whether that causes other mutations or other risks downstream. So, there’s work on both paths of vaccine development.”

Zuckerberg took a different stance when appearing in a virtual forum in November 2020 with Dr. Anthony Fauci, a leading government scientist.

“Just to clear up one point, my understanding is that these vaccines do not modify your DNA or RNA. So that’s just an important point to clarify,” Zuckerberg said, prompting Fauci to say: “No, first of all, DNA is inherent in your own nuclear cell. Sticking in anything foreign will ultimately get cleared.”

Facebook didn’t respond to a request for comment.

A Third of Service Members Have Refused Coronavirus Vaccines, Defense Officials Say

The Washington Post reported:

About 33 percent of service members have declined voluntary coronavirus vaccinations, defense officials said Wednesday, acknowledging that more inoculations would better prepare the military for worldwide missions.

Nearly 150,000 service members are fully vaccinated, a panel of defense officials told lawmakers in a House Armed Services Committee hearing on the Pentagon’s coronavirus response. About two-thirds of troops who were offered the vaccine accepted it. There are about 1.3 million active-duty troops.

The acceptance rate “mirrors preliminary data that we see in other communities” of Americans, Air Force Brig. Gen. Paul Friedrichs, a Joint Chiefs of Staff health official, told lawmakers.

The military is collecting data on race and ethnicity among those who accept vaccinations, Friedrichs said in a discussion about reluctance that some communities have about the vaccine. But the officials acknowledged limitations in what they can do to compel troops to receive vaccinations.

***

February 17

COVID-19: World’s First Human Trials Given Green Light in UK

BBC News reported:

Healthy, young volunteers will be infected with coronavirus to test vaccines and treatments in the world’s first COVID-19 “human challenge” study, which will take place in the UK.

The study, which has received ethics approval, will start in the next few weeks and recruit 90 people aged 18-30.

They will be exposed to the virus in a safe and controlled environment while medics monitor their health.

To Get Their Lives Back, Teens Volunteer for Vaccine Trials

The New York Times reported:

To reach students, some researchers have tapped school connections, local pediatricians and social media campaigns. While waiting for appointments in the vaccine research clinics, some teenagers, ignoring advice to keep their vaccine volunteering off of social media, have posted TikTok videos, which have inspired friends to sign up. But the adolescent COVID vaccine trials will be much smaller than the adult trials — two or three thousand subjects instead of 30,000.

“You want to enroll as many kids as necessary but as few as possible, to expose as few as possible,” said Dr. Robert W. Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital Medical Center.

To enroll in a trial, children must give “assent,” a legally required, age-appropriate version of “consent.” But researchers must also obtain the parent’s consent or permission. Information sessions for each can be protracted and painstaking. Objection by either child or parent terminates the application.

Insiders at COVID-19 Vaccine Makers Sold Nearly $500 Million of Stock Last Year

Wall Street Journal reported:

Executives and directors at Pfizer Inc., Moderna Inc. and other companies developing COVID-19 vaccines sold approximately $496 million of stock last year, reaping rewards of positive vaccine developments that drove up the value of the drugmakers’ shares.

Executives and directors at the same 13 companies sold about $132 million of stock in 2019, according to insider transaction data from research firm Kaleidoscope. More than 8.5 million shares were sold last year by insiders at these companies, compared with 4.7 million shares in 2019.

In dollar terms, much of the sales came at a single company, Moderna, maker of one of two COVID-19 vaccines authorized for use in the U.S. Executives and a director there sold more than $321 million of their stock in more than 700 transactions. Merck & Co. insiders sold $58 million of their shares. At Novavax Inc., executives sold more than $40 million of their shares after the company’s vaccine hit milestones in August and September.

My Teens Are Coronavirus Vaccine Guinea Pigs

The New York Times reported:

The day after my teenagers got their first shots in the Moderna COVID vaccine trial, I found my 13-year-old daughter, Zoe, sprawled out in bed during a distance-learning art class. Under a pile of blankets, she said she had chills. My heart skipped a beat. Any other time I would have worried about her missing school or Nordic ski practice, but this time I was elated when her temperature peaked at 100.5 degrees.

A fever meant she was probably reacting to a real mRNA vaccine, and not a placebo. Maybe she’d won the vaccine lottery!

When Pfizer and Moderna were granted emergency authorization to license their vaccines in December, the shots were approved for people as young as 16 and 18, respectively. But in order to end the pandemic, many experts said that younger children will need to be vaccinated.

The adolescent COVID vaccine trials, for kids 12 to 18, got off to slow starts, in part because they took a while to find participants — Pfizer didn’t fill its 2,259 slots until late January and Moderna is still screening applicants to fill its 3,000 spots. These trials also may require more months of data to complete (perversely, as infection rates decrease, it will take longer for enough teens to become infected to see how the vaccines perform; plus kids may contract the virus less frequently than adults).

AstraZeneca, Johnson & Johnson and Novavax, whose vaccines aren’t licensed in the United States for adults yet, haven’t begun testing in children. Still, Moderna is hoping adolescents can at least start getting vaccinated before the beginning of the next school year.

Brooklyn Woman Fired From Job After Not Getting Vaccine Because She Wanted to Wait

4 NBC New York reported:

“My husband and I just got married, and were planning on starting to try to have children in August,” Jacobson said. “It’s already been postponed, I would hate for something to happen and me get the vaccine and we have to hold off a few more years.”

She said that the restaurant initially told her getting the vaccine was not required. But just days ago, she said the tavern changed course, telling her in an email she received Monday that they respected her decision but “we have implemented this policy to maintain a safe working environment.”

She said that the restaurant initially told her getting the vaccine was not required. But just days ago, she said the tavern changed course, telling her in an email she received Monday that they respected her decision but “we have implemented this policy to maintain a safe working environment.”

The email to Jacobson then stated that getting the shot was mandatory, and that “at this time your employment will be terminated. We are sad to see you go.”

Jacobson said she was stunned by the move.

“I was just like wow, really? I worked for you through a pandemic. We’ve been 100 percent outdoors, I’ve been working in the heat, in the cold. I just worked a 13-hour double on Sunday, Valentine’s Day,” she said.

V.P. Kamala Harris Calls for Teachers to Get COVID Vaccine Priority

Chicago Tribune reported:

“Teachers should be a priority,” said Harris on Wednesday. “They should be able to teach in a safe place …. So teachers should be a priority along with other frontline workers.”

Harris told Today Show host, Savannah Guthrie that only about half the states are giving vaccine priority to teachers and called on states to put educators at the front of the line.

“We all want schools to reopen … All of us with children in our lives, they want to back to school …Teachers want to teach,” Harris said.

South Africa To Return 1 Million COVID-19 Vaccine Doses To Serum Institute

GreatGameIndia reported:

South Africa conducted a clinical trial that showed that vaccines by Serum Institute offer minimal protection against Coronavirus strain active in the country, after which South Africa stopped its COVID-19 vaccination program. Owing to this finding, South Africa has now decided to return approximately 1 million vaccine doses back to Serum Institute. These doses were supplied to South Africa in early February.South Africa had stopped the AstraZeneca Oxford COVID-19 vaccine program after disappointing results from trial data showed it gave minimal protection against mild to moderate infection caused by the country’s dominant coronavirus variant.

***

February 16

Four People in Oregon Who Received Both Doses of Vaccine Test Positive for Coronavirus

NBC News reported:

Four people in Oregon have tested positive for the coronavirus after receiving both doses of the COVID-19 vaccine, health officials said.

There are two cases each in Yamhill and Lane counties, the state’s Health Authority said in a series of tweets on Friday. The cases are either mild or asymptomatic.

“We are working with our local and federal public health partners to investigate and determine case origin,” the agency said. “Genome sequencing is underway, and we expect results next week.”

The agency referred to the individuals who tested positive as “breakthrough cases,” meaning that they got sick with the virus at least 14 days after receiving both doses.

The Health Authority said more breakthrough cases could pop up.

CDC to Investigate Nebraska Man’s Death Following COVID-19 Vaccination

PennLive News reported:

The Department of Health and Human Services has been made aware of the death of an individual in Nebraska, for which COVID-19 vaccine was listed as one of several causes of death, a report revealed.

A News Channel Nebraska report said the individual was “a male in his late 40s.” He had a “number of comorbidities” and was a long-term care facility resident.

The report said he died Jan. 17, “between 1 and 2 weeks after receiving his first dose of a COVID-19 vaccine,” which he received the first week of January.

The death has been entered in VAERS, News Channel Nebraska said.

California Woman, 78, Dies After Vaccination, Though No Sign of Link

NBC News reported:

A 78-year-old woman died shortly after being inoculated at a mass vaccination site in Los Angeles County, health officials announced Saturday, though there was no evidence the vaccine was at fault.

The patient’s family said she had a history of heart illness, said Dr. Michael E. Morris, director of Kaiser Permanente Southern California’s vaccination program, in a statement.

The woman “passed away unexpectedly” Friday after receiving Pfizer’s version of the COVID-19 vaccine about noon at the Kaiser-run site at Cal Poly Pomona, 30 miles east of downtown Los Angeles, the doctor said.

“While seated in the observation area after the injection, the patient complained of feeling discomfort and while being evaluated by medical personnel, she lost consciousness,” he said. “Paramedics on scene began CPR almost immediately and continued, but she ultimately could not be revived.”

Nearly a Third of U.S. Adults Are Undecided About the COVID Vaccine. Some Say Friends and Family Could Sway Them.

CNN Health reported:

Though officials and health experts say the end of the COVID pandemic will rely on a large proportion of Americans being inoculated, nearly a third of US adults say they have not decided if they will get the vaccine when it is offered to them.

About 31% of adults say they plan to “wait and see” how it works out for other people — and about two-thirds of that group say they may be persuaded to get one if they’re convinced it would be highly effective in preventing illness, according to an analysis released Friday of a previous study by the Kaiser Family Foundation.

“Wait and see” adults are “an important target for outreach and messaging” if the nation aims to increase the numbers of people willing to get the vaccine, but it is important to understand that their concerns vary, the foundation wrote.

WHO Authorizes Astrazeneca’s COVID Vaccine for Emergency Use

AP News reported:

The World Health Organization has granted an emergency authorization to AstraZeneca’s coronavirus vaccine, a move that should allow the U.N. agency’s partners to ship millions of doses to countries as part of a U.N.-backed program to tame the pandemic.

In a statement Monday, the WHO said it was clearing the AstraZeneca vaccines made by the Serum Institute of India and South Korea’s AstraZeneca-SKBio.

The WHO’s green light for the AstraZeneca vaccine is only the second one the U.N. health agency has issued after authorizing the Pfizer-BioNTech vaccine in December. Monday’s announcement should trigger the delivery of hundreds of millions of doses to countries that have signed up for the U.N.-backed COVAX effort, which aims to deliver vaccines to the world’s most vulnerable people.

Oxford-Astrazeneca Testing COVID Vaccine in Children as Young as 6

Fox News reported:

The University of Oxford has launched a trial to study the safety and efficacy of the AstraZeneca COVID-19 vaccine in children as young as 6. The study, which Oxford University said is the first of its kind, will involve 300 volunteers, 240 of which will receive the vaccine while the 60 others will receive a meningitis shot.

The university said the 60 who will receive the meningitis shot will serve as the control, and that the jab is safe in children but also is expected to produce similar reactions such as a sore arm.

The trial, which is aimed to study the AstraZeneca vaccine in children and teens aged 6 to 17 will build on previous data that showed the jab’s safe and effective when used on adults.

Pfizer recently announced that a trial involving children as young as 12 reached full enrollment, and Moderna is planning a trial for children ages 12-17.

CDC Updates COVID-19 Guidelines for Those Who Are Fully Vaccinated

WTVM reported:

As Americans continue to get both doses of the COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC) is releasing new quarantine guidelines for those who are fully vaccinated.

The latest data from the Georgia Department of Public Health’s Vaccine Distribution Dashboard shows nearly 1.45 million Georgians have gotten the COVID-19 vaccine. More than 403,000 Georgians have gotten a second dose of the Pfizer or Moderna vaccines, according to the state’s most recent data.

The CDC has three main criteria for those who have been fully vaccinated and exposed to someone suspected of having COVID-19.

“They would not have to quarantine if they’ve had both doses within the last three months. You had to have your second dose two weeks before that time that you were exposed, and also not showing any symptoms,” said Pamela Kirkland with the Columbus Health Department.

***

February 12

COVID-19 Vaccine Trials to Include Participants as Young as 6 Months

If you want the COVID-19 vaccine and aren’t in line to get it, there are still a number of vaccine trials- some involving kids.

There are 100, 12 to 17-year-olds participating in the Moderna adolescent trial through Houston Fights COVID. There are more trials coming, and the groups are now seeking participants as young as six months old.

“In about 30 days, we’re going to start another trial that is six months to 17 years old, but that’s about 30 days away,” said Elizabeth Hoff, the executive director at DM Clinical.

While that trial is 30 days away, Hoff is encouraging people to sign up now. She’s expecting a lot of interest in trials for children.

Children weren’t a part of the initial large phase three trials so this is a big step in getting closer to getting kids vaccinated.

“The more that adolescents are getting vaccinated, the more that our schools can open more safely and that the teachers do feel [safer] and that the parents do feel [safer],” said Hoff.

From the young to our seniors, Houston Fights COVID-19 is calling on those 65 and older to participate in several trials.

36-Year-Old Doctor Dies After Second Dose of COVID Vaccine

The Defender reported:

The Centers for Disease Control and Prevention (CDC) is investigating the death of a 36-year-old doctor in Tennessee who died Feb. 8, about a month after receiving the second dose of a COVID vaccination.

According to news reports, Dr. Barton Williams died from the adult form of multisystem inflammatory syndrome (MIS-A), a condition caused when the immune system attacks the body resulting in multi-system organ failure. MIS-A is considered extremely rare.

The Daily Memphian and other news sources reported that those involved in the investigation believe Williams developed MIS-A in response to an asymptomatic case of COVID-19, not the vaccine.

Dr. Stephen Threlkeld, an infectious disease specialist who treated Williams and is working with the CDC to investigate the death, told a Memphis ABC News affiliate that Williams tested negative for COVID while in the hospital and that Williams had told him that to his knowledge, he had not the virus.

653 Deaths + 12,044 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show

The Defender reported:

As of Jan. Feb. 4, 653 deaths — a subset of 12,697 total adverse events — had been reported to the Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccinations. The numbers reflect reports filed between Dec. 14, 2020 and Feb. 4, 2021.

VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirmation can be made that the reported adverse event was caused by the vaccine.

As of Jan. Feb. 4, 653 deaths — a subset of 12,697 total adverse events — had been reported to the Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccinations. The numbers reflect reports filed between Dec. 14, 2020 and Feb. 4, 2021.

VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirmation can be made that the reported adverse event was caused by the vaccine.

Fauci Says 20k Pregnant Women Got COVID-19 Vaccine With ‘No Red Flags’

The New York Post reported:

Dr. Anthony Fauci on Wednesday said about 20,000 pregnant women have received the COVID-19 vaccine “with no red flags.”

The top infectious disease expert announced the update at a Wednesday White House briefing, adding both the CDC and the FDA are monitoring the situation.

Guidance for pregnant women receiving the coronavirus vaccine have varied as they did not participate in either Pfizer-BioNTech and Moderna vaccine trials.

But Fauci said Wednesday that COVID-19 vaccine clinical trials for pregnant women and children are underway, with more to come.

The Centers for Disease Control and Prevention suggests pregnant women discuss with their healthcare provider the decision to get vaccinated.

The World Health Organization, however, does not recommend pregnant women receive the COVID-19 vaccine unless they are at high risk of exposure.

National Media Pushes Vaccine Misinformation — Coroner’s Office Never Saw Hank Aaron’s Body

The Defender reported:

Late last month, the mainstream media attacked me in a regimented swarm “debunking” my quote in The Defender questioning whether Hank Aaron’s death might have been related to the Moderna COVID-19 vaccine he received 18 days earlier.

I never said that the Moderna shot caused Aaron’s death. I simply made the factual observation that “Aaron’s tragic death is part of a wave of suspicious deaths among elderly closely following administration of COVID vaccines.”

Among the apoplectic hive of “fact checkers” that condemned this statement as “misinformation” were Meet the Press, NBC, The New York Times, The Washington Post, USA Today, Chicago Tribune, Inside Edition and many more.

The Daily Beast headline summarized the media’s moral revulsion at my query: “RFK Jr. Stoops to New Low by Falsely Tying Hank Aaron’s Death to Vaccine.”

Shortly after this high-tech media lynching, Instagram permanently deplatformed my 800,000 follower account.

The New York Times, citing the Fulton County coroner’s office, assured the public that “the Covid vaccine did not kill Hank Aaron.” NBC’s national wire service reported that the Fulton County coroner declared that Aaron’s death was from “natural causes unrelated to the vaccine.”

Require Workers to Get Vaccinated? Not on Main Street: Small Business Owner Survey

CNBC reported:

Barely more than one in five small business owners (22%) will require their employees to get COVID-19 vaccines when they become available, according to the latest CNBC|SurveyMonkey Small Business Survey. Twice as many (42%) say they won’t mandate vaccinations.

Whether to require workers to be vaccinated as soon as possible has become a controversial topic in the business community. With little guidance coming from the federal government, business leaders have been leftSome business owners view vaccinations as the key to a full reopening, some companies are even offering incentives to workers who get inoculated, while others want to avoid overstepping their bounds.

The new survey, conducted January 25-31 among 2,157 small business owners nationwide using SurveyMonkey‘s online platform and based on its survey methodology, reveals a particular hesitancy among the small business community, who have already spent the last year struggling to adapt as the pandemic rolls on.  to make decisions on their own.

Fauci: It’ll Be ‘Open Season’ for Vaccine Eligibility by April

Daily Beast reported:

The end may be in sight. Dr. Anthony Fauci, the nation’s top infectious disease expert and a scientific adviser to President Biden, said Thursday that it would be “open season” for adults to get the COVID-19 vaccine by April. “The number of available doses will allow for much more of a mass vaccination approach,” Fauci told NBC’s Today Show, citing the White House’s plans to ramp up distribution, and the pending approval of a third vaccine, made by Johnson & Johnson.

Later in the day, President Biden announced the U.S. will have enough doses to vaccinate 300 million Americans by the end of July. The administration purchased an additional 100 million vaccines from Moderna and 100 million from Pfizer.

“Virtually anybody, and anyone, in any category, could start to get vaccinated” by the end of April, Fauci said, though he added that it would likely take a few more months to achieve herd immunity. He also said officials were concerned about a new strain of the virus from the U.K. but vaccines have so far proven effective against it.

California man tests positive for COVID-19 weeks after getting second vaccine dose

The Mercury News reported:

Monday marked three weeks since a Lake Forest man received his second dose of the Pfizer COVID-19 vaccine, and one day since he got a positive COVID-19 test result.

“Yesterday, I got a phone call from the Orange County Health Department,” Gary Michael said. “They told me that, yes, I’m positive with coronavirus, and they went through my symptoms and the precautions of what I should do as far as quarantine.”

Michael was tested for the virus when he went to Mission Hospital in Mission Viejo on Saturday for an unrelated health issue.

“You might be surprised by this man’s story, this patient’s story, I’m not, and it’s not the first one that I’ve heard of,” Dr. Tirso del Junco Jr., chief medical officer of KPC Health, said. “I think I’ve heard of six or seven independent cases over the last three weeks of individuals that have been vaccinated with different timelines that have tested positive, and I think we’re going to continue to see that more and more.”

AstraZeneca Plans to Double COVID-19 Vaccine Output

The Wall Street Journal reported:

AstraZeneca PLC said it was fixing problems with the manufacturing of its Covid-19 vaccine and expects to roughly double monthly production to 200 million doses by April, as it seeks to move past a rocky start to the shot’s rollout.

The Anglo-Swedish drugmaker reported strong full-year earnings and forecast increased 2021 earnings growth. The forecast doesn’t factor in sales of the pandemic vaccine it developed alongside the University of Oxford.

Like other vaccine makers, AstraZeneca and Oxford are working on new versions of the shot to target existing and emerging variants of the coronavirus. The drugmaker said Thursday it hoped to reach production of an adapted vaccine at scale within six to nine months, using clinical-trial data and manufacturing agreements already in place.

Massachusetts Offered Vaccines to Seniors’ Caregivers. Some Are Offering Cash to the Elderly to Get in on the Deal.

Washington Post reported:

The suspicious posts began appearing on Craigslist on Thursday afternoon, a few hours after health officials in Massachusetts announced a key expansion of who could receive the coronavirus vaccine. “Companions” to those older than 75 were now eligible, the state said, but only if these caregivers helped accompany seniors to vaccination sites.

Suddenly, it seemed on the classifieds website, plenty of younger residents wanted to start spending time with septuagenarians. Especially if money was involved.

“Some people [are] posting online, trying to get a senior to bring them to a vaccination site, or in some cases asking to be paid to drive somebody to one,” Massachusetts Gov. Charlie Baker (R) said at a news conference Thursday, calling the ads “pretty disturbing.”

The ensuing fracas over the “companion system” has since been criticized by some state lawmakers, who say it all but guaranteed to encourage dangerous scams and fail to ensure Massachusetts’s most vulnerable populations will receive the vaccine first.

Biden Says U.S. Faces ‘National Emergency’ Amid Vaccine Shortage

Al Jazeera reported:

President Joe Biden said that the United States is facing a “national emergency” in the coronavirus pandemic and his administration is working to supply enough COVID-19 vaccine to inoculate 300 million Americans.

“We’re in a national emergency,” said Biden, wearing a mask during remarks to scientists at the National Institutes of Health just “This will be one of the most difficult operational challenges we have ever undertaken as a nation. It’s going to take time,” Biden said.

The U.S. is on pace to exceed Biden’s goal of administering 100 million vaccine doses in his first 100 days in office, with more than 26 million shots delivered in his first three weeks. The 300 million doses would be delivered by the end of the US summer, Biden said.

Biden Administration Finalizes Deal for 200 Million Vaccine Doses From Pfizer, Moderna

NBC News reported:

The U.S. has finalized a previously announced deal with Pfizer and Moderna for 200 million more coronavirus vaccine doses, which should provide enough to vaccinate nearly every American, President Joe Biden said Thursday.

During a visit to the National Institutes of Health, Biden said the federal government signed the final contracts Thursday afternoon for 100 million more doses of the Moderna vaccine and 100 million more from Pfizer and BioNTech.

Biden said last month that he was directing the federal government to secure the additional doses on top of the 400 million ordered during the Trump administration. With the new order in place, the U.S. will have enough supply to fully vaccinate 300 million people with the two-dose vaccines, Biden said.

Children Less Likely to Report Fever, Persistent Cough, or Appetite Loss, Large UK Study Finds

The BMJ reported:

Young people aged five to 17 with COVID-19 are less likely to report fever, persistent cough, or appetite loss than adults, according to a UK study of more than a million people.

The latest findings from the ongoing React-1 study, which involves swab testing more than 150 000 randomly selected people in England each month, found that symptoms varied with age. Researchers examined swab tests and questionnaires from between June 2020 and January 2021 and found that children aged five to 17 were more likely to suffer from headaches, while muscle aches and appetite loss were most common in people aged 18-54. Chills were linked with testing positive across all ages.

The study — published as a preprint1 paper — also found that around 60% of infected people did not report any symptoms in the week leading up to their positive test.

This comes after the UK Biobank SARS-CoV-2 Serology study found that around one in four people with evidence of past COVID-19 infection were completely asymptomatic, while 40% did not have one of the three classic symptoms used to determine whether someone needs testing—fever, persistent dry cough, or loss of sense of taste or smell.2

New Israeli Drug Cured 29 of 30 Moderate/Serious COVID Cases in Days — Hospital

The Times of Israel reported:

A new coronavirus treatment being developed at Tel Aviv’s Ichilov Medical Center has successfully completed phase 1 trials and appears to have helped numerous moderate-to-serious cases of COVID-19 quickly recover from the disease, the hospital said Friday.

Hailing a “huge breakthrough,” the hospital said Prof. Nadir Arber’s EXO-CD24 substance had been administered to 30 patients whose conditions were moderate or worse, and all 30 recovered — 29 of them within three to five days.

The medicine fights the cytokine storm — a potentially lethal immune overreaction to the coronavirus infection that is believed to be responsible for much of the deaths associated with the disease.

***

February 11

Fauci: Vaccines for Kids as Young as First Graders Could Be Authorized by September

ProPublica reported:

Children as young as first graders may be able to get the coronavirus vaccine by the time school starts in September, presuming trials are successful in those age groups, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview with ProPublica.

“We’re in the process of starting clinical trials in what we call age de-escalation, where you do a clinical trial with people 16 to 12, then 12 to 9, then 9 to 6,” Fauci said. When asked what was the youngest age group that might be authorized for the vaccine by September, he said, “I would think by the time we get to school opening, we likely will be able to get people who come into the first grade.”

Doctors Suspect COVID Delayed Immune Response in Young Surgeon’s Death

Daily Memphian reported:

A young orthopedic surgeon with OrthoSouth who died early Monday, Feb. 8, may be the nation’s first case of an adult who died of a delayed immune response to COVID and had received the vaccine.

Dr. J. Barton Williams died early Monday at Baptist Memorial Hospital-Memphis. He was 37.

“What we think so far is that he suffered from multi-system inflammatory syndrome (MIS),” said Baptist infectious disease expert Dr. Stephen Threlkeld.

The syndrome, more common in children, often looks and acts like Kawasaki disease, which causes inflammation in the blood vessels.

MIS is a reaction in someone who has had the COVID infection weeks or months earlier and mounted a severe, delayed immune reaction, which often causes significant damage to the organs.

Require Workers to Get Vaccinated? Not on Main Street: Small Business Owner Survey

CNBC reported:

Barely more than one in five small business owners (22%) will require their employees to get COVID-19 vaccines when they become available, according to the latest CNBC|SurveyMonkey Small Business Survey. Twice as many (42%) say they won’t mandate vaccinations.

Whether to require workers to be vaccinated as soon as possible has become a controversial topic in the business community. With little guidance coming from the federal government, business leaders have been left to make decisions on their own.

Some business owners view vaccinations as the key to a full reopening, some companies are even offering incentives to workers who get inoculated, while others want to avoid overstepping their bounds. The new survey, conducted January 25-31 among 2,157 small business owners nationwide using SurveyMonkey’s online platform and based on its survey methodology, reveals a particular hesitancy among the small business community, who have already spent the last year struggling to adapt as the pandemic rolls on.

More than four in 10 small business owners (43%) say they have had to shut down operations at some point as a result of the pandemic, including 20% who say they have since reopened at limited capacity; 10% who say they still have not reopened; and even 4% who say they shut down, reopened, and then shut down again.

How Merck, a Vaccine Titan, Lost the COVID Race

The New York Times reported:

From Ebola to H.I.V. to river blindness, the American pharmaceutical giant Merck has been on the front lines of the biggest public health emergencies in recent history.

So when the company announced last May that it was a late entrant in the race to develop a COVID-19 vaccine, Merck was a popular pick to win. Even if the company wasn’t first, proponents argued, its expertise as the world’s second-largest vaccine maker gave it a good shot at developing the best product — and manufacturing it quickly.

But then, last month, Merck exited the vaccine race, abandoning its two candidates after early clinical trials flopped. Now, in addition to testing two experimental COVID-19 drugs, the company says that it’s looking for ways to help competitors supply the world with vaccines.

“We are in regular conversation with governments, we’re in regular conversations with the public health authorities, with the foremost experts on all this,” said Michael T. Nally, the chief marketing officer at Merck. The company, he said, is now asking: “With all that we know today, what is the best way for us to help?”

***

February 10

UN: ‘Concerning News’ Vaccines May Not Work Against Variants

Associated Press reported:

The head of the World Health Organization said Monday the emergence of new COVID-19 variants has raised questions about whether or not existing vaccines will work, calling it “concerning news” that the vaccines developed so far may be less effective against the variant first detected in South Africa.

Tedros Adhanom Ghebreyesus said at a media briefing that South Africa’s decision on Sunday to suspend its vaccination campaign using the AstraZeneca vaccine is “a reminder that we need to do everything we can to reduce circulation of the virus with proven public health measures.”

He said it was increasingly clear that vaccine manufacturers would need to tweak their existing shots to address the ongoing genetic evolution of the coronavirus, saying booster shots would most likely be necessary, especially since new variants of the virus are now spreading globally and appear likely to become the predominant strains.

Tucker Carlson on COVID Vaccine Rollout: ‘Tons of Celebrity Endorsements, Not a Lot of Science’

The Defender reported:

Tucker Carlson has a few questions about COVID vaccines. At the top of his list is: “Why are Americans being discouraged from asking simple, straightforward questions about [vaccines]?”

On Tuesday’s “Tucker Carlson Tonight” segment, the Fox News commentator suggested there’s “nothing QAnon about questions like that.”

He continued:

“They are not conspiracy theories, they’re the most basic questions. In a democracy, every citizen has a right to know the answer, but instead we got fluff and propaganda.”

Carlson then went on to say:

“The media rollout for the vaccine came off like a Diet Pepsi commercial at the Super Bowl. Tons of celebrity endorsements, not a lot of science.”

Pfizer, Regeneron Hit With Patent Suits Over COVID-19 Tech

Law 360 reported:

Pfizer Inc. and Regeneron Pharmaceuticals Inc. were accused Monday of using poached technology in their development and testing of COVID-19 vaccines and treatments, according to a pair of patent infringement suits lodged in California and New York federal court.

San Diego-based Allele Biotechnology and Pharmaceuticals Inc. is claiming the pharmaceutical giants infringed its patented mNeonGreen technology, which it said is an important reagent used to develop therapeutics for the virus. The technology was patented in 2019, and it’s used in testing antibody and vaccine candidates, Allele said.

Notably, the technology was used in Regeneron’s experimental “antibody cocktail” given to President Donald Trump last week to treat his COVID-19 infection. Hundreds of organizations and universities have licensed the mNeonGreen technology, but Pfizer and Regeneron aren’t among them, according to Allele.

“This lawsuit follows because [Pfizer] made the deliberate and calculated decision to infringe rather than even so much as pick up the phone and seek to obtain the rights to use Allele’s valuable intellectual property,” Allele said in its suit against Pfizer.

Denver Mayor, City Officials Urge Immediate COVID Vaccines for the Homeless

FOX 31 reported:

Denver Mayor Michael Hancock and city officials continue to push for making people experiencing homelessness a priority in COVID-19 vaccination policies.

Instead of using the current age-based approach, Hancock and the Denver Joint Task Force said in a memo to state officials last week that a location-based prioritization strategy should be implemented to get COVID vaccines right away to homeless residents.

How COVID Vaccines Might Change the Dating Game

WTOP News reported:

Matchmakers have reported seeing intense demand for partners who have received both doses of the Pfizer or Moderna shots. Dating sites have recorded dramatic upticks in mentions of the word vaccine. Even if you eavesdrop on masked and distanced hangouts at public parks, it seems everyone is desperately seeking someone who has gotten injected.

“Getting vaccinated or being open to getting it is the hottest thing you could do right now,” said Michael Kaye, spokesperson for the dating site OKCupid.

Doctors Say Some Are Opting Out of Second Vaccine Dose in Fear of Side Effects

News Channel 5 reported:

Dr. Aaron Milstone of Williamson County Medical Center says some of his patients are reluctant to get the second dose of the COVID-19 vaccine, having heard of potential side effects.

While most side effects for the second dose range from fever to chills and muscle soreness, Dr. Milstone says misinformation has been shared across social media to make these side effects appear much worse.

“I’ve had a fair number of patients come in and say I’m only going to get the one dose. I felt good with it, I didn’t have any side effects, why go ahead and tempt fate,” Milstone said.

Dr. Milstone received both doses of a COVID-19 vaccine and says he did not react to the first dose. Only after receiving the second dose did he experience chills for about four hours. What Dr. Milstone knew is that this immune response is a sign that the vaccine is working.

He says it’s a normal response as your body begins to make the antibodies necessary to fight off the virus and develop immunity. With just one dose, Dr. Milstone says you’re only protected at about 50%. With both doses, you can reach more than 95% protection.

CVS, Walgreens, Other Pharmacies to Begin Delivering COVID-19 Vaccines Within Days

USA TODAY reported:

After weeks of vaccine distribution being largely limited to hospitals, health systems and local health departments, COVID-19 vaccines are poised to roll out at major pharmacies throughout the country, including the nation’s two largest chains, CVS and Walgreens.

While state-determined eligibility and availability will remain limited for the time being, experts say they’re hopeful that the nation’s established network of pharmacies will help speed up distribution amid consternation over the pace of the rollout so far.

“I have no doubt” that it will, said Bunny Ellerin, director of the Healthcare and Pharmaceutical Management Program at Columbia Business School.

She said that the major pharmacy chains are especially well-suited to handle the distribution campaign because they manage flu vaccinations for millions of Americans annually, giving them expertise that pop-up sites might lack.

South Africa Pivots to Unapproved Johnson & Johnson Vaccine After Scrapping Astrazeneca

Fox 29 reported:

South Africa will give the unapproved Johnson & Johnson vaccine to its front-line health workers beginning next week as a study to see what protection it provides from COVID-19, particularly against the variant dominant there, the health minister said Wednesday.

Zweli Mkhize said South Africa has scrapped plans to use the Oxford-AstraZeneca vaccine because it “does not prevent mild to moderate disease” of the variant.

The one-shot J&J vaccine is still being tested internationally and has not been approved in any country.

But Mkhize, in a nationally broadcast address, declared that the vaccine is safe, relying on tests of 44,000 people done in South Africa, the United States and Latin America.

Feb. 10 South Korea to Approve AstraZeneca as First COVID-19 Vaccine, Including for Elderly

Reuters reported:

South Korea on Wednesday said it would grant its first approval for a coronavirus vaccine to AstraZeneca, and will allow use in people 65 years or older, despite advisory panels’ warning of a lack of data on its efficacy for the elderly.

Regulators will grant AstraZeneca’s vaccine emergency authorisation under the condition the company must submit its full clinical trial results, Vice Health Minister Kim Gang-lip told a news conference.

“However, we have added a precautionary line for cautious decision for use of the shots the elderly aged 65 and older,” Kim said.

Several European countries have warned that the shot should only be given to those ages 18 to 64, and such concerns had threatened to upend South Korea’s plan to prioritise elderly residents and medical workers in the first round of vaccinations.

On Monday, authorities sought to reassure elderly residents after a panel of advisers urged caution over the use of the AstraZeneca vaccine for people older than 65 because of a lack of data.

Italy Teachers Balk at AstraZeneca Vaccine Plans

Associated Press reported:

 Italy’s main teachers’ union is balking at plans for educators under age 55 to receive the AstraZeneca vaccine rather than jabs it believes provide better protection, evidence that lobbying groups are vying to get specific shots as the virus and its variants spread across Europe.

The CISL School union said in a statement Monday that it wanted a meeting with Italy’s government scientific committee. It complained that it hadn’t been consulted about the decision to start up the vaccine drive for teachers ahead of schedule, with some of the first 250,000 AstraZeneca doses that arrived over the weekend.

The Italian government rejiggered its vaccination plans last week after Pfizer-BioNTech and Moderna reduced vaccine deliveries and Italy’s pharmaceutical agency gave “preferential use” for AstraZeneca shots for people aged 18 to 55. The government is now directing its Pfizer and Moderna shots to inoculate people over age 80 while designating the AstraZeneca jabs for younger, at-risk workers.

WHO Expert Panel Recommends Wide Use of Astrazeneca COVID Vaccine

Reuters reported:

In interim recommendations on the shot, the Strategic Advisory Group of Experts on Immunisation (SAGE) panel said the vaccine should be given in two doses, with an interval of around 8 to 12 weeks between the first and second doses.

SAGE also said that even where questions have been raised about the vaccine’s efficacy against a South African variant of the coronavirus, “there is no reason not to recommend its use”.

South Africa this week paused its rollout of the AstraZeneca vaccine after data from a small trial showed it did not protect against mild to moderate illness from the 501Y.V2 variant of the coronavirus now dominant in the country.

Astrazeneca’s COVID-19 Vaccine Has Been Confusing From the Start

The Verge reported:

The rollout of the AstraZeneca-Oxford vaccine has been messy from the start. The team behind it was one of the most vocally optimistic groups about the potential of its product, and the company said last spring that it could start delivering doses by September 2020. Former President Donald Trump’s Department of Health and Human Services jumped on those projections, saying vaccines would arrive in the United States in October 2020.

Those projections would prove unrealistic. Clinical trials of the vaccine were paused over safety concerns in September, slowing its progress, and initial data wasn’t released until late November. At that time, the company announced that the vaccine was up to 90 percent effective, a huge accomplishment. Later, it turned out that the high efficacy was only in a small number of people who were incorrectly given weaker doses of the vaccine. Weirdly, the company’s two full-strength doses seemed less effective. The data was hard to interpret and seemed counterintuitive to researchers.

Could a Single Vaccine Work Against All Coronaviruses?

The New York Times reported:

Dr. Modjarrad is one of many scientists who for years have been calling for a different kind of vaccine: one that could work against all coronaviruses. Those calls went largely ignored until Covid-19 demonstrated just how disastrous coronaviruses can be.

Now researchers are starting to develop prototypes of a so-called pancoronavirus vaccine, with some promising, if early, results from experiments on animals. Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Institute in San Diego, thinks scientists should join together in another large-scale vaccine-creation project immediately.

“We have to get a real work force to accelerate this, so we can have it this year,” he said. Dr. Topol and Dennis Burton, a Scripps immunologist, called for this project on broad coronavirus vaccines on Monday in the journal Nature.Opinion: We Need to Enroll Pregnant Women in Clinical Trials for the Coronavirus Vaccines

Washington Post reported:

Barring pregnant women from early clinical trials out of fear for their safety and the safety of their fetuses puts the onus on pregnant women and their doctors to weigh the risks and benefits of the vaccine without definitive evidence — and that’s not fair.

Our past mistakes must not deter pregnant women from getting vaccinated. But they must become the impetus for change.

Excluding pregnant women from trials has long been a common practice, in part because of concerns about safety for women and their fetuses and liability for those conducting the trials. But during pregnancy, women end up using drugs and vaccines that have not been tested on pregnant people.

Top UK Scientist Warns ‘Unpredictable’ COVID Evolution Threatens Vaccine Success

Financial Times reported:

One of the UK government’s top scientific advisers has warned that early signs the Oxford/AstraZeneca vaccine is less effective at stopping mild and moderate cases of the South African coronavirus variant are a “worrying harbinger” for 2021. Sir Jeremy Farrar, director of the Wellcome Trust medical charity and a member of the government’s Sage advisory committee, told the Financial Times that this year was “very unpredictable” as new viral variants less susceptible to current control methods were likely to undermine efforts to contain the virus.

Signs of the reduced efficacy of the Oxford/AstraZeneca vaccine against the 501.V2 variant in a limited South Africa study have already caused the country to suspend rollout of the jab, pending more data. Oxford university and AstraZeneca have said their vaccine should still protect against severe cases of the disease and that they are working on a tweaked shot that could be available before the end of the year.

Farrar warned that the question of vaccine efficacy was “not just a problem for South Africa”. Biological and immunological pressure would “undoubtedly” lead to more variants around the world this year that could have higher transmission rates, higher fatality rates and be more difficult to prevent, he said.

A Series of Knocks: Oxford/Astrazeneca’s Bumpy Road to COVID Vaccine Confidence

The Guardian reported:

The Oxford University/AstraZeneca vaccine against Covid has barely been out of the news from the moment the race to protect the world’s population from the novel coronavirus began. But not always in a good way.

Talented scientists at the Jenner Institute at Oxford University, led by Prof Sarah Gilbert, were incredibly quick off the mark in developing a potential vaccine, as soon as the virus in Wuhan had been sequenced and made globally available by Chinese scientists on 11 January. They were using an experimental but exciting approach they had tried in Mers (Middle East respiratory syndrome), caused by a similar coronavirus.

University academics cannot run the huge trials needed, in tens of thousands of people in different countries around the world, on their own. They went into partnership in April with AstraZeneca, a large multinational pharma company that – unlike some – was willing to develop and sell the vaccine for no profit for the duration of the pandemic. Oxford made that a precondition, intent on producing a vaccine that could save lives in poor and rich countries alike.

Eli Lilly’s Antibody Combination Receives FDA Emergency Use Authorization for COVID-19

Reuters reported:

Eli Lilly’s combination antibody therapy to fight COVID-19 has been granted emergency use authorization by the U.S. Food and Drug Administration, Lillys aid on Tuesday.

Lilly’s combination therapy of two antibodies, bamlanivimaband etesevimab, helped cut the risk of hospitalization and death in COVID-19 patients by 70%, data from a late-stage trial showedin January.

Lilly said the therapy will be available immediately.

“There are 100,000 doses ready immediately and an additional 150,000 doses will be available throughout the first quarter,”Lilly said in a statement.

***

February 9

Man in 70s Collapses, Dies After Getting COVID Vaccine in NY: Officials Saw No Sign of Allergic Reaction

Channel News8 reported:

Health officials confirmed early Monday that a man died shortly after getting the COVID-19 vaccine Sunday morning at the Jacob Javits Convention Center in Manhattan.

The man collapsed as he was leaving the Hudson Yards vaccination site, New York State Health Commissioner Howard Zucker said.

On-site security and first responders rushed to his side within seconds, however the man died at a local hospital a short time later, according to Zucker.

Doctors Link Pfizer, Moderna Vaccines to Life-Threatening Blood Disorder

The Defender reported:

For the second time in under a month, The New York Times has published an article about people who developed a rare autoimmune disease after receiving COVID vaccines.

Monday’s article featured two women, both of whom were described as healthy before they received the Moderna vaccine. The women, ages 72 and 48, are now being treated for immune thrombocytopenia (ITP), a condition that develops when the immune system attacks platelets (blood component essential for clotting) or the cells that create them, according to the Times.

On Jan. 13, the Times reported on the death of Dr. Gregory Michael, a Florida doctor who died 15 days after getting the Pfizer vaccine. Michael, who was 56 and described as “perfectly healthy” by his wife, developed ITP three days after being vaccinated. He died of a brain hemorrhage on Jan. 3. As The Defender reported on Jan. 13, Dr. Jerry L. Spivak, an expert on blood disorders at Johns Hopkins University, said it was a “medical certainty” the Pfizer vaccine led to Michael’s death.

Spivak, who was interviewed for Monday’s article in the Times, reiterated the link between the vaccine and ITP. Two other doctors, Dr. James Bussel, a hematologist and professor emeritus at Weill Cornell Medicine who has written more than 300 scientific articles on the platelet disorder, also said he thinks there is a “possible” association between the vaccines and ITP.

Bussel told the Times:

“I’m assuming there’s something that made the people who developed thrombocytopenia susceptible, given what a tiny percentage of recipients they are. Having it happen after a vaccine is well-known and has been seen with many other vaccines. Why it happens, we don’t know.”

New Data on Astrazeneca Vaccine Add to Worries Over Coronavirus Variant From South Africa

Bio Pharma Dive reported:

The world has bet more on the AstraZeneca and Oxford vaccine than any other. AstraZeneca expects to make more than 3 billion doses this year, the most of any vaccine maker, and a large chunk of those have been pre-ordered by several countries. The shot can also be stored and distributed in refrigerator conditions, making it a crucial part of the global immunization campaign.

Yet several setbacks and confusing clinical results have slowed the vaccine’s progress and dampened enthusiasm regarding its potential. Though the shot appears to prevent COVID-19 caused by the original strain of SARS-CoV-2, researchers still aren’t sure what the best dosing regimen is or how effective it is in the elderly. The vaccine also may slow transmission of the virus, though again, it’s unclear to what degree.

A large U.S. study, expected to read out in February or March, could finally clear up the confusion. But in the meantime, the fresh data presented Sunday raise new questions about its utility.

The study tested whether two doses of the vaccine or placebo could prevent mild to moderate COVID-19 14 days or more after the second shot. A preliminary analysis conducted after 42 cases, showed that 23 occurred in 717 placebo recipients, compared to 19 of 750 who got the vaccine — a roughly 22% reduction and well short of the goals established by regulators across the globe.Study: U.K. coronavirus variant doubling every 10 days in the U.S.

COVID-19 Vaccines Are Likely Safe During Pregnancy. When Will We Know for Sure?

VOX Media reported:

People who are pregnant should be able to decide if they want to get the coronavirus vaccine, U.S. health agencies and medical organizations resoundingly agree. And in the first couple months of vaccine rollout, many pregnant health care workers have already chosen to do so.

Israel also recently added higher-risk pregnant women to its vaccine priority list. But other countries, such as the UK, and the World Health Organization are saying most should wait.

Why the disagreement? The clinical trials of the new COVID-19 vaccines explicitly excluded pregnant people, and we don’t yet have enough follow-up data from individuals who have opted to get the shots to say for sure they are safe during pregnancy. And so some governments and the WHO are being extra cautious about greenlighting the vaccine for all pregnant people.

The U.S. and many national medical groups — including the American College of Obstetrics and Gynecology, the Society for Maternal-Fetal Medicine, and the Academy of Breastfeeding Medicine — say the vaccine should be offered to this group in large part because there’s strong evidence that pregnancy elevates the risk for severe Covid-19 and death. (Given this data, the American Society for Reproductive Medicine goes so far as to say the vaccine is “recommended” for those who are pregnant or considering pregnancy.)

***

February 8

Deaths After Pfizer Vaccination at Spanish Nursing Home Aggravate Concerns

Global Times reported:

Concerns over the mRNA vaccine intensified following a Russia Today report on Monday that all 78 residents at a nursing home in Madrid, Spain had tested positive for COVID-19 after being given their first dose of the Pfizer-BioNTech vaccine on January 13, and at least seven people have died.

A Chinese virologist advised elderly people, especially those with underlying conditions, not to take mRNA vaccine such as Pfizer’s, as it could induce their condition and worsen their health, while a vaccine expert warned the public to take appropriate measures even after being vaccinated, as people are likely to be infected with the virus before the vaccine takes effect.

Most of those who succumbed to the virus had pre-existing conditions, according to Spanish news agency EFE, while four residents are hospitalized, and 12 staff members have also been infected, Russia Today reported.

The report didn’t say whether the deaths and cases testing positive are directly linked to vaccination.

Defense Department Sending 1,000 Troops to Assist With Vaccinations

NBC News reported:

Biden administration officials said they will deploy 1,000 active duty troops to assist with Covid-19 vaccinations later this month and use the Defense Production Act to increase supplies of vaccine, tests and protective equipment.

The military personnel will begin arriving in California within the next 10 days and assist at state vaccination sites there, said COVID-19 coordinator Jeffrey Zients. The Pentagon is still weighing a broader request from FEMA for up to 10,000 troops, a U.S. military officer said.

Defense Secretary Lloyd Austin made the decision, which will involve units from the Army, Navy, Air Force and Marine Corps and include nurses and medical staff who will be administering the vaccinations, the officer said.

“The military’s critical role in supporting sites will help vaccinate thousands of people per day, and ensure that every American who wants a vaccine will receive one,” said Zients.

South Africa Pauses AstraZeneca Vaccine Rollout After Study Shows it Offers Less Protection Against Variant

CNN reported:

South African health officials said Sunday they’re pausing the country’s rollout of AstraZeneca’s coronavirus vaccine after a study showed it offered reduced protection from the Covid-19 variant first identified there.

During a briefing on Sunday, South Africa Minister of Health Dr. Zweli Mkhize said the hold would be temporary while scientists figure out how to most effectively deploy the AstraZeneca vaccine. Mkhize said South Africa will move forward with the deployment of vaccines made by Pfizer/BioNTech and Johnson & Johnson.

Early data released Sunday suggest two doses of the Oxford/AstraZeneca Covid-19 vaccine provided only “minimal protection” against mild and moderate Covid-19 from the variant first identified in South Africa.

The study, which has not been released, included about 2,000 volunteers who were an average of 31 years old; about half received the vaccine and half received a placebo, which does nothing.

Early data released Sunday suggest two doses of the Oxford/AstraZeneca Covid-19 vaccine provided only “minimal protection” against mild and moderate Covid-19 from the variant first identified in South Africa.

The study, which has not been released, included about 2,000 volunteers who were an average of 31 years old; about half received the vaccine and half received a placebo, which does nothing.

A Holistic View of Vaccine Hesitancy

New York Times reported:

It wasn’t necessarily that he didn’t trust vaccines, it was that he didn’t trust the government that was pushing it. This mistrust, I believe, is an underappreciated part of vaccine hesitancy, particularly among younger Black people.

It is now a well-established fact that Black people are getting the vaccine less than their white counterparts and also express more doubt about it. But those numbers are more complicated than the top-line takeaways might suggest.

A survey released Thursday by the National Foundation for Infectious Diseases found some interesting age variations. As CNN reported:

“The survey, which was conducted in December 2020, also revealed that older Black adults and men are more willing to get the COVID-19 vaccine. For example, 68 percent of adults age 60 and older said they planned to get the vaccine while only 38 percent of Black adults age 18-44 planned to get it. Many of the younger respondents expressed distrust in the healthcare system, saying it treats people unfairly based on race and ethnic background, according to the survey findings.”

Older and Disabled Texans Are Demanding Their Home Caregivers Be Vaccinated for COVID-19. but Many Workers Don’t Want It.

Texas Tribune reported:

Houston home health caregiver Rachel Fuentes is struggling between her need to stay employed and her fear of the COVID-19 vaccine.

Fuentes, 43, worries that her employer will make vaccinations mandatory, or that she won’t find clients who will let her care for them if she’s unvaccinated.

One of her co-workers, a 33-year-old, is already facing that reality: The assisted living facility where her client lives has said that if she’s not vaccinated by May 1, she won’t be allowed in.

Both women say they are more afraid of the injection than of catching COVID-19, which both say they have staved off by following safety protocols for a year.

“I don’t know what’s going to happen to me. Health care is all I’ve known,” said the 33-year-old, who asked to remain anonymous because she fears backlash from people who know her and because she hasn’t told the older man she cares for that she will probably have to stop caring for him.

Katie Price Reveals Son Harvey, 18, Is ‘Well’ After Reaction to COVID Jab Saw Him Rushed to Hospital With High Temperature… as She Urges Others to Get Vaccinated

Daily Mail reported:

Katie Price has revealed that her son Harvey is home and well, after he was rushed to hospital following a bad reaction to the COVID-19 vaccine.

The former glamour model, 42, took to her Instagram Stories with her 18-year-old offspring by her side on Sunday as she revealed he suffered a reaction after taking the first of his Oxford/AstraZeneca jabs on Friday.

And the mother-of-five revealed that once she got her eldest son home from the hospital, he was back ‘on form’, requesting chicken Kiev and chips at 4am.

NFL Tells White House It’s Ready to Make Every Stadium a Vaccination Site

CNN reported:

Every NFL team will make its stadium available as a mass vaccination site, NFL commissioner Roger Goodell wrote in a letter to President Joe Biden dated Thursday.

The offer comes as the Biden administration has promised the opening of mass vaccination sites as part of its push to ramp up the pace of Covid inoculations.

“This is currently being done at seven NFL stadiums today,” Goodell wrote. “We can expand our efforts to stadiums across the nation more effectively because many of our clubs have offered their facilities previously as COVID testing centers as well as election sites over the past several months.”

According to an NFL spokesman, the seven clubs that have already activated vaccination sites “at or near their stadium” are Arizona (State Farm Stadium), Atlanta (Mercedes-Benz Stadium), Baltimore (M&T Bank Stadium), Carolina (Bank of America Stadium), Houston (NRG Park), Miami (Hard Rock Stadium) and New England (Gillette Stadium).

The NFL has also been in communication with the White House regarding coronavirus response efforts on another front — Sunday’s Super Bowl. CNN reported earlier Thursday that the President and first lady Jill Biden have taped a video message thanking health care workers that will be shown before the game, according to a source familiar with the plans.

An administration official told CNN that the White House also hoped to use Sunday’s event to combat vaccine hesitancy and speak to the African American, Latino and White, rural “non-mask-wearing” communities in particular. The Super Bowl presents “an interesting opportunity to reach all three of those audiences,” the official said.

Annual Vaccines and Autumn ‘Booster’ Could Be Required to Combat New COVID Variants, Minister Says

The Independent reported:

The minister responsible for the coronavirus vaccine rollout has suggested annual jabs or a “booster in the autumn” could be required to combat new variants of the disease.

Nadhim Zahawi’s remarks came as official government data showed on Sunday that over 12 million people in Britain had now received a first dose of a COVID vaccine — putting the government on course to reach the 15 February target of inoculating 15 million in high priority groups.As Boris Johnson prepares to tell the nation how the government will begin unwinding the lockdown in two weeks, Mr Zahawi insisted he was confident the NHS would be able to reach the new “tough” target of immunising all those over the age of 50 by May.

***

February 5

The Many Faces of COVID-19 Experimental ‘Vaccine’ Deaths

Ghion-Journal reported:

These are but a few of the countless victims mainstream media refuse to mention and politicians conveniently overlook as they maliciously go about inflating the death count associated with COVID-19. It’s a most pernicious endeavor; opinion leaders on all fronts omit more and more people who are dying immediately after they take injections of a supposed “vaccine” or, as evidenced by the links I provided above, go out of their way to dismiss the “vaccine” as a the cause of death even though most of them were doing perfectly well up until they offered their arms as sacrificial limbs to Biotech corporations.

These same chiselers deceptively lump people who die as a consequence of heart disease, diabetes, cancer or a myriad of medical conditions into the COVID-19 mortality rate. There is of course a reason they do this; hospitals are incentivized financially to report COVID-19 deaths. Providers are being reimbursed by Medicare for each patient who is listed as being positive, on a ventilator and/or passes away from the dreadful virus. Doctors are likewise being paid directly by CMS upwards of $45 per injection. And of course we all know that our politicians are nothing more than harlots who are being pimped out by Wall Street; most of them being funded directly by Biotech corporations.

501 Deaths + 10,748 Other Injuries Reported Following COVID Vaccine, Latest CDC Data Show

The Defender reported:

As of Jan. 29, 501 deaths — a subset of 11,249 total adverse events — had been reported to the Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) following COVID-19 vaccinations. The numbers reflect reports filed between Dec. 14, 2020, and Jan. 29, 2021.

VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before confirmation can be made that an adverse event was linked to a vaccine.

As of Jan. 29, about 35 million people in the U.S. had received one or both doses of a COVID vaccine. So far, only the Pfizer and Moderna vaccines have been granted Emergency Use Authorization in the U.S. by the U.S. Food and Drug Administration (FDA). By the FDA’s own definition, the vaccines are still considered experimental until fully licensed.

According to the latest data, 453 of the 501 reported deaths were in the U.S. Fifty-three percent of those who died were male, 43% were female, the remaining death reports did not include the gender of the deceased. The average age of those who died was 77, the youngest reported death was of a 23-year-old. The Pfizer vaccine was taken by 59% of those who died, while the Moderna vaccine was taken by 41%.

The latest data also included 690 reports of anaphylactic reactions to either the Pfizer or Moderna vaccines. Of those, the Pfizer vaccine accounted for 76% of the reactions, and the Moderna vaccine for 24%.

58-Year-Old Woman Dies Hours After Getting First Dose of Pfizer Vaccine

The Defender reported:

State and federal officials are investigating the death of a 58-year-old woman in Virginia, who died hours after receiving the first dose of Pfizer’s COVID-19 vaccine.

Drene Keyes, described as a “gifted singer and grandmother of six,” found herself unable to breathe and began vomiting within a couple hours of being vaccinated, according to media reports. She was rushed to Riverside Tappahannock Hospital, where doctors administered an EpiPen, CPR and oxygen.

Keyes’ daughter, Lisa Jones, told WKTR:

“They tried to remove fluid from her lungs. They called it ‘flash pulmonary edema,’ and doctors told me that it can be caused by anaphylaxis. The doctor told me that often during anaphylaxis, chemicals are released inside of a person’s body and can cause this to happen.”

After being vaccinated, Keyes waited the recommended 15 minutes during which she was observed by healthcare workers.

Jones said her mother had underlying health conditions, was obese, diabetic, and took cholesterol and blood pressure medications, the Daily Express reported. Still, Keyes qualified for the vaccine, and as Jones told WBRZ, her mother “was wanting to protect herself, and it did not turn out that way.”

Pfizer Drops India Vaccine Application After Regulator Seeks Local Trial

Reuters reported:

Pfizer Inc. said on Friday it had withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India, after failing to meet the drug regulator’s demand for a local safety and immunogenicity study.

The decision means the vaccine will not be available for sale in the world’s two most populous countries, India and China, in the near future. Both countries are running their immunisation campaigns using other products.

Unlike other companies conducting small studies in India for foreign-developed vaccines, Pfizer had sought an exception citing approvals it had received elsewhere based on trials done in countries such as the United States and Germany.

Indian health officials say they generally ask for so-called bridging trials to determine if a vaccine is safe and generates an immune response in its citizens. There are, however, provisions under India’s rules to waive such trials in certain conditions.

Johnson & Johnson Seeks Emergency FDA Authorization for Single-Shot Coronavirus Vaccine

Washington Post reported:

Pharmaceutical giant Johnson & Johnson submitted its single-shot coronavirus vaccine to U.S. regulators Thursday afternoon for emergency use authorization after the vaccine was shown to be robustly effective against illness in a global trial — and especially at preventing severe disease and death.

FDA officials announced that outside experts would discuss the vaccine at a public meeting three weeks from now, on Feb. 26.

In a news release last week, the company announced its vaccine was 66 percent effective overall at preventing moderate to severe illness in a global clinical trial. It offered the best protection against severe cases of disease, proving 85% effective. There were no hospitalizations or deaths among people who received the vaccine. That result held up even in the South Africa portion of its trial, where a concerning virus variant that has shown the ability to evade some immunity has become dominant.

The data has not been peer-reviewed or published but will be carefully reviewed by career FDA scientists and an external panel of experts who will determine if the vaccine meets the safety and efficacy requirements for emergency use.

Can AstraZeneca’s Vaccine Prevent the Spread of COVID-19 Virus?

TIME reported:

In a new — yet to be peer-reviewed — study, the pharmaceutical company AstraZeneca and its partners at the University of Oxford report that their COVID-19 shot may not only protect against disease but also help to prevent spread of the SARS-CoV-2 virus. The news was heralded by policy makers desperate to see a vaccine that can curb spread of the disease, but scientists have been a bit more cautious. If confirmed, the results would represent a breakthrough in the COVID-19 vaccine race.

So far, the shots authorized or approved around the world have shown strong protection against moderate to severe disease, but haven’t definitively proven that people who get vaccinated are less likely to spread the COVID-19 virus. But the data, say some experts, is confusing, so it’s hard to adequately evaluate the company’s claim that the shot can actually slow the spread of COVID-19 or not.

In the study, published on the Lancet pre-print server (which means the results have not been peer-reviewed, a gold standard for ensuring the scientific rigor of the findings) AstraZeneca and Oxford scientists report that two doses of their vaccine was overall 66.7% effective in protecting against COVID-19 disease. As part of its analysis, the research team also collected nasal swabs from vaccinated and unvaccinated study volunteers in the U.K. every week and tested them for the virus. The scientists found that positive tests were about 50% lower among people who got two doses of the vaccine compared to those who weren’t vaccinated. Because people who do not test positive are less likely to spread the virus, the researchers extrapolated from those data that the AstraZeneca shot can lower transmission of the COVID-19 virus.

However, that may be a bit of a stretch, says Dr. Carlos del Rio, executive associate dean of Emory School of Medicine. “It’s a leap of science that I think still needs to be proven,” he says. “What they show is that there was [either] decreased viral shedding or decreased detection of virus,” However, they do not actually show that transmission was decreased. “We can say less transmission is a possibility but the data on that needs to come out,” says Del Rio. “We want to state the facts and don’t want to over state the facts.”

Bipartisan Lawmakers Call for Immediate Vote on COVID Vaccine Distribution Package

The Hill reported:

Members of the bipartisan Problem Solvers Caucus are calling for an immediate vote on a $160 billion COVID-19 vaccine distribution package in an effort to direct funding to the matter as soon as possible as Congress continues the reconciliation process on a broader package.

The measure reflects the language in the Biden administration rescue plan on vaccines and the numbers that have been discussed by congressional negotiations.

In addition to distributing federal funds toward vaccination efforts, the package would also boost overall funding.

The package includes $20 billion for the National Vaccine Program’s partnership with states, tribes, and territories; $50 billion for expansion of testing; $30 billion for the Disaster Relief Fund; $5 billion for Defense Production Act Title III, which provides the administration broad authority to allocate funds for certain policies and national security purposes; $5 billion for PPS for first responders, independent physicians offices and dentists; $15 billion to rebuild and restock the National Strategic Stockpile and $35 billion for the Provider Relief Fund, which would require 20 percent to be set away for rural hospitals.

Even After Witnessing COVID’s Toll, Many Georgia Health Workers Balk at Vaccine

AJC reported: 

They’ve seen the death and suffering up close. As COVID-19 has ripped across Georgia, caregivers at nursing homes and other senior care facilities have had to struggle to contain the virus, break news to families when loved ones test positive and seen beds emptied as residents they’ve cared for over months succumb.

Just this week, the state surpassed 4,000 resident deaths in long-term care, with 709 of those deaths in January, the deadliest month to date. More than 25,000 residents have been infected.

Their caregivers haven’t escaped the toll, either. More than 14,000 have been infected. At least 29 have died of COVID as of mid-January, federal nursing home reports show.

FDA Will Draft Guidance to Work With Vaccine, Drug and Testing Companies on COVID-19 Variants

USA TODAY reported:

Concerned about new variants of the virus that causes COVID-19, the U.S. Food and Drug Administration announced late Thursday that it is developing guidance to help vaccine, drug and testing manufacturers adapt.

Existing vaccines, treatments and tests still work well, emphasized the FDA’s acting commissioner Janet Woodcock. But now is the time to get ready for a future when they may not.

“We must prepare for all eventualities,” she said in a call with reporters.

Within the next few weeks, the FDA will provide draft guidance to manufacturers on how to adapt their products as needed, Woodcock said. Feedback from companies and others will help refine that guidance.

Amtrak Will Pay Employees to Get Coronavirus Vaccine

The Philadelphia Enquirer reported:

***

February 4

CDC Head: Vaccinating Teachers ‘Not A Prerequisite’ for Safe School Reopening

The Hill reported:

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky emphasized Wednesday that vaccinating teachers is not required for safely reopening schools, citing data from her agency to say it is possible to return to in-person classes as long as other precautions are taken.

“Vaccination of teachers is not a prerequisite for safe reopening of schools,” Walensky said during a press briefing.

She added that while a CDC advisory committee has put teachers in the “1B” category for getting vaccines — the second priority group for vaccination — “I also want to be clear that there is increasing data to suggest that schools can safely reopen and that … safe reopening does not suggest that teachers need to be vaccinated in order to reopen safely.”

From RFK Jr to Latin America, Poland’s Anti-Vaxxers Find Friends Abroad

Balkan Insight reported:

“This is a global problem that is being pushed by a global medical cartel, the global pharmaceutical companies and regulatory agencies,” Kennedy went on to claim. “And our response must be global as well. We need to create institutions that are enduring, persistent and strong enough to counter the unleashed power of this medical tyranny.”

Kennedy, an environmental lawyer turned anti-vax campaigner, is the son of the former U.S. attorney general and assassinated presidential candidate Robert F. Kennedy and nephew of former president John F. Kennedy. His appearance at the session was popular, with over 200,000 views and 6,000 shares on Facebook alone, and is indicative of how existing connections between domestic and foreign anti-vaxxers, far-right politicians and ultra-conservative groups are proving useful in disseminating anti-COVID vaccination rhetoric throughout Poland.

At the same time, the pandemic is helping to create new opportunities for these networks. While much has been made of Russian-produced disinformation – and this is an issue in Poland, too – many ‘COVID entrepreneurs’ from across Europe, the US, Latin America and elsewhere are contributing to the ‘infodemic’ in Poland while pursuing their own anti-democratic, anti-EU or populist agendas.

70% to 85% of Americans Need to Be Fully Vaccinated for a Return to Normal, Fauci Says. So Far It’s Less Than 2%

CNN reported:

About 70% to 85% of the U.S. population should be fully vaccinated against COVID-19 before the country can begin to return to a sense of normalcy, Dr. Anthony Fauci told CNN Tuesday night.

So far, less than 2% of Americans have received both doses of a COVID-19 vaccine, according to data from the Centers for Disease Control and Prevention.

Across the U.S., nearly 34 million COVID-19 vaccine doses have been administered, with more than 27 million people having received at least one dose — or just over 8% of the population.

About 6.4 million people have received both doses, the CDC data shows.

Fauci said he’s hopeful the country can get to that high level of vaccinations by the end of the summer to the beginning of fall.

Why Are so Many Health-Care Workers Resisting the COVID Vaccine?

The New Yorker reported:

Chance doesn’t want a coronavirus vaccine. (Because it’s not known how long naturally acquired immunity lasts, the C.D.C. recommends that people who have already had the virus still get vaccinated.) I asked her how she has come to believe that one vaccine saved her life but another threatens her health.

The vaccine “came out too fast,” she said. “I think they removed a lot of barriers to get it done faster.” She continued, “It’s not that I don’t believe they’re trying to do a good job. I think they have awesome scientists working really hard. I applaud them for doing what they’re doing. I just don’t believe there’s been enough research yet. There’s no way they’ve been studying it for long enough.”

Beyond the speed of development, Chance has questions — about how long vaccine-generated immunity lasts, about how serious the long-term side effects might be, and about what could happen if the virus mutates further. Until these questions are answered to her satisfaction, she has no plans to get immunized. “I’m not saying never,” Chance told me. “I’m just saying not now.”

Switzerland Refuses to Approve Astrazeneca Jab and Says ‘New Studies’ Are Needed After France, Germany and Sweden Rejected It for Over-65s

The Daily Mail reported:

Switzerland has refused to approve the AstraZeneca COVID, vaccine with regulators raising concerns over insufficient test data and arguing ‘new studies’ are needed.

It comes after France, Sweden and Germany advised against administering the jab to those over 65 and Emmanuel Macron claimed it was ‘almost ineffective’ for the age bracket.

That is despite Oxford data published this week suggesting the jab is 76% effective after just one dose, and may also prevent 67% of infection.

Continental objections to the jab come amid a furious row between the EU and AstraZeneca over lagging supply, which has seen newly-unshackled Brexit Britain storm ahead in its immunisation roll-out.

Israel Leads World in COVID Vaccinations, But Challenges Remain

Medical Xpress reported:

Israel has become the world leader in COVID-19 vaccine rollouts, inoculating millions of its citizens against the coronavirus in a matter of weeks.

But the nation is still under a full lockdown and likely will remain so for a while longer, given the highly infectious nature of new COVID-19 variants out of the United Kingdom, South Africa and Brazil, said Dr. Ran Balicer, chair of Israel’s COVID-19 National Experts Team.

“In this race the virus wins, especially given the fact that when you have like we do over 50% of your new cases caused by the British variant, which is obviously more infective and therefore disseminates more quickly,” Balicer said during a recent HD Live! interview.

Israel has administered more than 55 doses for every 100 people in the nation, according to Bloomberg News, compared to 10 doses per 100 citizens in the United States and 15 per 100 in the United Kingdom.

Pfizer Spent Months Working to Extract Sixth Dose From Vials as Vaccine Production Shortfalls Loomed

Washington Post reported:

Beginning in August, a half-dozen researchers at a Pfizer lab in Massachusetts sat down with vials of experimental coronavirus vaccine to learn how to transform the “overfill” in every vial — an extra amount of liquid that is standard for injectable pharmaceuticals — into a precious sixth dose.

Over the next few months, they tested dozens of different combinations of syringes and needles, drawing out vaccine and squirting it into a beaker resting on a digital scale, repeating the experiments 5 to 10 times for each.

By Jan. 6, the work paid off.

Pfizer won approval from the Food and Drug Administration to say its vials contained six doses, instead of the five the agency had approved less than a month earlier with its Dec. 11 emergency authorization of the vaccine.

After a Rocky Start, Novavax Vaccine Could Be Here by Summer

New York Times reported:

Manufacturing troubles had forced the little-known Maryland company, which in its 34-year history had never brought a vaccine to market, to delay the U.S. clinical trial of its experimental COVID-19 inoculation, jeopardizing its $1.6 billion contract with the federal government. And two COVID-19 vaccines made by its competitors were already shipping around the country, leaving some to wonder whether Novavax would ever catch up.

But the picture has significantly improved. The company announced last week that its vaccine showed robust protection in a large British trial and also worked, although not nearly as well, in a smaller study in South Africa against a contagious new variant.

And the scarcity of the two vaccines authorized in the United States, made by Moderna and Pfizer, seems to have made it easier for Novavax to recruit volunteers in its trial here. That speedy enrollment has put the company on track to have results this spring, with possible government authorization as early as April. If all goes right — and nothing is guaranteed — that would mean an influx of 110 million vaccine doses, enough for 55 million Americans at two doses each, by the end of June.

CDC Suggests Smokers Before Teachers for COVID-19 Vaccine

WKRN reported:

Updated Centers for Disease Control and Prevention guidelines prioritize smokers over teachers.

The reason? People who use tobacco have increased chances of hospitalization, and even death, caused by the coronavirus.

Smoking is now labeled by the CDC as a medical condition that increases risk of severe illness from COVID-19 explains Vanderbilt infectious disease doctor, David Aronoff.

“One of the things the CDC has been working really hard on is trying to identify risk factors for doing poorly with COVID-19 that might warrant prioritizing getting the vaccine.”

Scientists Test a New COVID-19 Vaccine Question: Mixing Different Doses

The Wall Street Journal reported:

As the world keeps adding to its armory of effective vaccines against COVID-19, scientists are starting to ask a new question: What happens if you mix and match?

Researchers are beginning human trials in which volunteers will receive an initial dose of one vaccine and a booster shot from another made by a different manufacturer. The goal is to see if such a strategy—known as heterologous prime-boost vaccination—could produce a more effective immune response against the virus that causes COVID-19 than using two shots of a single vaccine.

India Survey Finds a Quarter of Children May Have COVID Antibodies, More Than Average

Reuters reported:

More than a quarter of Indian children aged between 10 and 17 may have already contracted COVID-19, according to a government serological survey released on Thursday, higher than the 21.5% of the overall population found to have been infected.

The survey of more than 35,700 people above 10, conducted in the last two months, gave a much lower estimate for the average number of people to have contracted COVID-19 than other research.

***

February 3

7 Die at Spanish Care Home After Getting Pfizer COVID-19 Jab as All Residents Test Positive for Virus, Second Doses Still to Come

RT reported:

All 78 residents at a nursing home in central Spain have tested positive for COVID-19 after being given their first dose of the Pfizer-BioNTech vaccine, and at least seven people have died, staff confirmed on Monday.

Most of those who succumbed to the virus had existing conditions, according to Spanish news agency EFE, while four residents are currently hospitalized, and 12 staff have also been infected.

The huge outbreak is at the Lagartera Residence for the Elderly in the Toledo area, southwest of the capital Madrid.

Pentagon Says Unspecified Number of Troops Are Refusing to Get the COVID-19 Vaccine

Task & Purpose reported:

While countless Americans are anxiously awaiting for their chance to get vaccinated against the novel coronavirus (COVID-19), an unspecified number of service members and other Defense Department personnel have refused to get inoculated, defense officials said.

In December, defense officials announced that the COVID-19 vaccination program for roughly 11 million personnel would be voluntary because the vaccine had only been approved on an emergency use basis and that service members and other personnel would not face any penalties if they decided not to get inoculated.

Only if the U.S. Food and Drug Administration fully licensed the COVID-19 vaccine would the Defense Department consider making it mandatory, then-Pentagon spokesman Jonathan Hoffman said at the time.

So far, the Defense Department has inoculated about 336,000 people, of which about 46,000 have received two doses of a COVID-19 vaccine, according to the U.S. Centers for Disease Control and Prevention’s website. But not all department personnel who have been eligible to get vaccinated have done so, said Air Force Brig. Gen. Paul Friedrichs, Joint Staff Surgeon.

“We’re not compelling people to take a vaccine,” Friedrichs said. “This is truly something that they have to volunteer for. And we’ve been very careful to adhere to — not just the letter — but the intent of the guidance that’s been put on that under the emergency use authorization.”

Pfizer, Johnson & Johnson Balk at Shareholders’ Push for COVID-19 Vaccine Pricing Info

FiercePharma reported:

What’s the rationale behind COVID-19 vaccine and drug prices? You don’t have a need to know — or so say a couple of the leading contenders.

Two major players in the pandemic fight, Pfizer and Johnson & Johnson, are urging the Securities and Exchange Commission to forestall shareholder resolutions that would require them to disclose how they set prices on their COVID-19 vaccines.

Several not-for-profit groups are pushing the two companies — along with fellow pharmas Eli Lilly, Gilead, Merck & Co. and Regeneron—for information on their drug and vaccine pricing decisions, citing the federal money all have received, either for supplies, R&D or manufacturing scale-up. Or all three.

GSK Inks Deal to Produce Curevac’s COVID-19 Vaccine — and Develop a Next-Gen Version, Too

FiercePharma reported:

After a recent trial setback, GlaxoSmithKline and partner Sanofi’s COVID-19 vaccine program looks to be a more distant contender in the first wave of immunizations. But as one of the world’s largest vaccine makers, the British pharma doesn’t want to miss out on this pandemic opportunity.

GSK will help CureVac manufacture up to 100 million doses of the German biotech’s first-generation mRNA COVID vaccine candidate, CVnCoV, in 2021, the two companies said Wednesday. In the meantime, the two companies will also work on a next-gen vaccine to tackle emerging variants.

“The key is to make sure that we follow and get ahead of the future of this virus,” GSK CEO Emma Walmsley said. The mRNA technology’s ability to be quickly modified and manufactured makes it a good platform for this purpose, she added.

Biden Administration Announces Direct Vaccine Shipments to Pharmacies

CNN reported:

“Millions of Americans turn to their local pharmacies every day for their medicines, flu shots, and much more. And pharmacies are readily accessible in most communities, with most Americans living within five miles of a pharmacy,” White House COVID-19 response coordinator Jeff Zients said in a briefing.

The program, which will begin rolling out February 11, will start at about 6,500 stores that will receive a total of 1 million doses before eventually expanding, Zients said.

The administration also announced it is increasing the weekly allocation of vaccines going to states, tribes and territories by an additional 5%, bringing the weekly total of vaccines purchased per week a minimum of 10.5 million.

What Went Wrong With America’s $44 Million Vaccine Data System?

Technology Review reported:

Unless you’re in one of the few states using it, you may not have heard of VAMS. But it was supposed to be a one-stop shop where employers, state officials, clinics, and individuals could manage scheduling, inventory, and reporting for COVID shots — and free for anyone to use.

Instead, “VAMS has become a cuss word,” Marshall Taylor, head of South Carolina’s health department, told state lawmakers in January. He went on to describe how the system has badly hurt their immunization efforts so far. Faced with a string of problems and bugs, several states, including South Carolina, are choosing to hack together their own solutions, or pay for private systems instead.

Clinic workers in Connecticut, Virginia, and other states say the system is notorious for randomly canceled appointments, unreliable registration, and problems that lock staff out of the dashboard they’re supposed to use to log records. The CDC acknowledges there are multiple flaws it’s working to fix, although it attributes some of the problems to user error.

Russia’s Sputnik V COVID Vaccine Appears Effective, Study Finds

NBC News reported:

Russian scientists say the country’s Sputnik V vaccine appears safe and effective against COVID-19, according to early results of an advanced study published in a British medical journal.

The news is a boost for the shot that is increasingly being purchased by nations around the world who are desperate to stop the devastation caused by the pandemic.

Researchers say based on their trial, which involved about 20,000 people in Russia last fall, the vaccine is about 91% effective and that the shot also appeared to prevent people from becoming severely ill with COVID-19. The study was published online Tuesday in the journal, Lancet.

The most commonly reported side effects were flu-like symptoms, pain at the injection site and fatigue. Serious side effects were rare in both groups and four deaths were reported in the study, although none were considered to be the result of the vaccine.

***

February 2

Pfizer Sees $15 Billion in 2021 Sales From COVID-19 Vaccine

Reuters reported:

Pfzer Inc said on Tuesday it expects to generate $15 billion, or about a quarter of its total revenue this year, from the sale of its COVID-19 vaccine co-developed with German partner BioNTech.

The drugmaker is striving to deliver two billion doses of the vaccine in 2021 at a breakneck pace as countries rush to sign supply deals in an effort to control a pandemic that has killed over 2 million people globally.

Pfizer said its forecast could go higher if the company signs more supply contracts.

“2021 earnings and sales will see a significant benefit from the vaccine, and this benefit could increase throughout the year,” said Edward Jones analyst Ashtyn Evans.

Report: Many U.S. Nursing Home Staff Decline First COVID Shots

ABC News reported:

The CDC looked at more than 11,000 nursing homes and skilled nursing facilities that had at least one vaccination clinic between the middle of December and the middle of January. The researchers found that while 78% of residents got at least one shot, only 37.5% of staff members did.

Data previously showed that people who work in nursing homes and long-term care facilities get flu vaccines at lower rates than other health-care workers. Surveys suggest that long-term care workers are skeptical the shots work and don’t think viruses spread easily from them to the people they care for.

Had COVID? You May Need Only One Dose of Vaccine, Study Suggests

New York Times reported:

Shannon Romano, a molecular biologist, came down with COVID late last March, about a week after she and her colleagues shut down their lab at Mount Sinai Hospital. A debilitating headache came first, followed by a fever that kept rising, and then excruciating body aches. “I couldn’t sleep. I couldn’t move,” she said. “Every one of my joints just hurt inside.”

It was not an experience she wanted to repeat — ever. So when she became eligible for the COVID-19 vaccine earlier this month, she got the shot.

Two days after her injection, she developed symptoms that felt very familiar. “The way my head hurt and the way my body ached was the same headache and body ache I had when I had COVID,” she said. She recovered quickly, but her body’s intense response to the jab caught her by surprise.

A new study may explain why Dr. Romano and many others who have had COVID report these unexpectedly intense reactions to the first shot of a vaccine. In a study posted online on Monday, researchers found that people who had previously been infected with the virus reported fatigue, headache, chills, fever, and muscle and joint pain after the first shot compared more frequently than did those who had never been infected. COVID survivors also had far higher antibody levels after both the first and second doses of the vaccine.

EU’s Quick Approval of AstraZeneca Driven by Political Considerations: Expert

Global Times reported:

The AstraZeneca vaccines demonstrated about 60 percent efficacy in clinical trials, deemed to meet EU standards, and European Medicines Agency (EMA) recommended its application for all adults from 18 years of age onwards, the EMA said on Friday as it recommended authorization of the vaccine. There are no solid results on how well the vaccine will work for the older population (aged over 55 years old), but EMA experts considered that the vaccine can be used in older adults.

Also, on Friday, the EMA said it identified no safety concerns with the COVID-19 vaccine jointly developed by Pfizer and BioNTech, and attributed the 23 reported deaths among frail and elderly patients in nursing homes in Norway to an adverse reaction to the first dose of the vaccine.

Oxford Researchers Didn’t Tell COVID-19 Vaccine Trial Volunteers of a Dosing Mistake When It Was Discovered, a Letter Reveals

Business Insider reported:

About 1,500 of the initial volunteers in a late-stage clinical trial of the Oxford/AstraZeneca COVID-19 vaccine were given the wrong dose, but weren’t informed that a mistake had been made after the blunder was discovered, documents obtained by Reuters show.

Instead, the dosing mishap was presented to the trial participants in a letter dated June 8 as an opportunity for University of Oxford researchers to learn how well the vaccine works at different doses. The letter was signed by the trial’s chief investigator, Oxford professor Andrew J. Pollard, and sent to the trial subjects.

U.S. Inks Deal for Tens of Millions of 15-Minute At-Home COVID Tests With 95% Accuracy

Daily Beast reported:

The Biden administration’s coronavirus response team announced Monday that the Pentagon and the Department of Health and Human Services have inked a deal with the Australian diagnostics manufacturer Ellume to make tens of millions of at-home COVID-19 test kits. The deal, valued at $230 million, will hopefully allow the company to ramp up production of nearly 20 million tests per month by the end of the year. The tests, approved by the Food and Drug Administration last December, provide results within 15 minutes, with 95 percent accuracy. Andy Slavitt, a senior administration adviser on COVID-19, called increasing production “a high priority, with obvious benefits” for American workplaces, schools, and health-care facilities.

***

February 1

U.S. Children Will ‘Hopefully’ Get Vaccines in Late Spring or Early Summer, Says Fauci

The Guardian reported:

“Hopefully by the time we get to the late spring and early summer we will have children being able to be vaccinated,” Fauci said.

COVID-19 vaccines are not yet approved for children. Supplies for adults and the logistics of providing shots are proving steep challenges for manufacturers, the administration and state governments. As of Thursday, only about 1.3% of Americans had received the required two doses of “Children tend to not become as severely ill as adults [from COVID-19] but they can still become ill and some have tragically died,” Dr Leana Wen, a public health expert, told the Associated Press. “Children can also be vectors of transmission, and getting children vaccinated is important.”

The federal Food and Drug Administration has not yet approved vaccines for children, due to insufficient testing data. Fauci said data was being gathered through a process called “age de-escalation testing”. The Pfizer/BioNTech vaccine received emergency approval for use in people 16 and older. The next step, Fauci said, involves testing in children down to 12. If successful it will be followed by another round of testing, down to nine years old.

Congressman Stephen Lynch Tests Positive for COVID-19 After Receiving Both Vaccine Doses

Huffington Post reported:

Rep. Stephen Lynch (D-Mass.), who received a second dose of the COVID-19 vaccine earlier this month, tested positive for the virus on Friday.

Another Democrat from Massachusetts, Rep. Lori Trahan, announced Thursday she had also tested positive. Both lawmakers are reportedly asymptomatic.

Lynch received two doses of the Pfizer-BioNTech vaccine prior to the inauguration of President Joe Biden on Jan. 20, Molly Rose Tarpey, Lynch’s communications director, said in a statement.

“While Mr. Lynch remains asymptomatic and feels fine, he will self-quarantine and will vote by proxy in Congress during the coming week,” she said.

Tarpey did not specify the exact date Lynch received the second dose of the vaccine.

Pfizer CEO Vows to Speed up Vaccine Development to Under 100 Days to Combat the ‘High Likelihood’ That Current COVID-19 Shots Will Need Upgrades to Stay Effective

Business Insider reported:

Speaking at the virtual 2021 Davos World Economic Forum, Pfizer CEO Albert Bourla said he believed there was a “high possibility” that current coronavirus vaccines would not be effective against new strains of the virus in the future, though that hasn’t happened yet.

“It’s a very high likelihood that one day that will happen,” Bourla said.

To prepare, Pfizer is planning to be able to create new versions of its vaccine quickly, he added. The goal is for those shots to have the same 95% efficacy against the coronavirus as Pfizer’s current shot, he said.

FEMA Asks Pentagon to Ready as Many as 10,000 Troops to Support Nationwide Vaccine Push

CBS News reported:

The Federal Emergency Management Agency (FEMA) has asked the Pentagon to ready as many as 10,000 troops to support 100 COVID-19 vaccination sites nationwide, with the goal of administering 450,000 vaccinations a day.

The federal government envisions 50 “mega” vaccination sites capable of administering 6,000 shots per day, in addition to 50 “large” vaccination sites providing 3,000 shots per day, according to defense officials.

The first of the FEMA-powered vaccination sites are expected to be operating by mid-February, a senior White House official told CBS News, and will scale up as vaccine production intensifies in the coming months.

EU’s Push for Vaccine Supplies Gets Help From Bayer Agreement

Bloomberg reported:

Bayer AG agreed to produce CureVac NV’s experimental coronavirus vaccine to boost the rollout of a promising shot as European Union governments scramble for additional supplies to spur a plodding campaign.

The move won’t have an immediate effect, though it’s at least some good news for Europe after a week of chaos surrounding its program. The controversy escalated after the European Commission threatened curbs on vaccine exports — sparking global anger — in response to news that AstraZeneca Plc would miss delivery targets.

Bayer’s production effort extends its current pact with CureVac on regulatory clearance and global distribution, and will start to deliver at the end of the year. It follows commitments from fellow European pharma giants Sanofi and Novartis AG to put their manufacturing capacities behind scaling up Pfizer Inc. and BioNTech SE’s COVID-19 injection.

Behind AstraZeneca’s COVID-19 Vaccine Stumble

Wall Street Journal reported:

AstraZeneca PLC Chief Executive Pascal Soriot promised to churn out more COVID-19 vaccines, at a lower price, than any of his big pharma competitors.

Now, a production problem at a single factory in Belgium has delayed tens of millions of doses destined for Europe, endangering the continent’s already-slow inoculation drive and representing the greatest threat so far to Dr. Soriot’s extraordinary pledge last year to vaccinate the world—and do so for no profit. After disclosing the European problem, the drugmaker now says it has been troubleshooting similar production issues in recent weeks as far away as the U.S. and Australia.

The setbacks, which come on the eve of a decision from regulators whether to recommend the shot for use in Europe, suggest AstraZeneca is falling behind in the vaccine arms race. The company has relatively little experience in vaccines, a tricky, typically low-margin niche in the global pharmaceuticals industry. The manufacturing process the company uses, piggybacking on a chimpanzee cold virus, can be more difficult to quickly scale up than the one employed by Pfizer Inc. and Moderna Inc., both of which use a new genetic technology.

***

January 29

White House Asks CDC to Study How Many Have Died After COVID Vaccine Shots

The Daily Beast reported:

The White House coronavirus task force wants to know whether individuals who have received the shot died as the result of an adverse event linked to the vaccination, such as anaphylaxis, from a coronavirus-related illness such as pneumonia, or from something else entirely. 

Currently, the CDC does not have a good way to track deaths that occur after vaccination in real time, officials said. The study would have to come from state health departments, many of whom are already overwhelmed with other data collection efforts related to COVID-19, including testing, case positivity, hospitalizations, and vaccine distribution.

The CDC has worked throughout the last year to reduce COVID-19 data reporting gaps but has struggled to collect timely information from some state health departments. The agency’s COVID mortality dataset — its information on how many suffered coronavirus-related deaths—is currently about five weeks behind, officials said. Its system for tracking vaccine complications is far from comprehensive. With 4,000 people dying per day and another million getting the COVID vaccine, such shortcomings and lags in data can present a particularly blurred picture. The agency is working on a 2020 mortality report analyzing coronavirus-related deaths in the first year of the pandemic. It is set to be released sometime in the spring, officials said, adding that there are no current plans to include vaccination data in the current CDC COVID-19 mortality analysis.

Governments Sign Secret Vaccine Deals. Here’s What They Hide.

New York Times reported:

Governments have poured billions of dollars into helping drug companies develop vaccines and are spending billions more to buy doses. But the details of those deals largely remain secret, with governments and public health organizations acquiescing to drug company demands for secrecy.

Just weeks into the vaccination campaign, that secrecy is already making accountability difficult. The drug companies Pfizer and AstraZeneca recently announced that they would miss their European delivery targets, causing widespread concern as dangerous virus variants spread. But the terms of their contracts remain closely guarded secrets, making it difficult to question company or government officials about either blame or recourse.

Available documents, however, suggest that drug companies demanded and received flexible delivery schedules, patent protection and immunity from liability if anything goes wrong. In some instances, countries are prohibited from donating or reselling doses, a ban that could hamper efforts to get vaccines to poor countries.

329 Deaths + 9,516 Other Injuries Reported After Getting COVID Vaccine, Latest CDC Data Show

The Defender reported:

As of Jan. 22, 329 deaths — a subset of 9,845 total adverse events — had been reported to the Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) by people who received COVID-19 vaccinations. VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S.

According to the Washington Post, as of Jan. 29, 22 million people in the U.S. had received one or both doses of a COVID vaccine. Only the Pfizer and Moderna vaccines have been granted emergency use authorization in the U.S. by the U.S. Food and Drug Administration (FDA). By the FDA’s own definition, the vaccines are considered experimental until fully licensed.

Even with the updated injury numbers released today, the CDC said Thursday that safety data shows “everything is going well.” According to USA TODAY:

“Early safety data from the first month of COVID-19 vaccination finds the shots are as safe as the studies suggested they’d be.

“Everyone who experienced an allergic response has been treated successfully, and no other serious problems have turned up among the first 22 million people vaccinated, according to the Centers for Disease Control and Prevention.”

According to the VAERS data, of the 329 reported deaths, 285 were from the U.S., and 44 were from other countries. The average age of those who died was 76.5.

‘Our Message Is to Take the Vaccine,’ Says Family of Man Whose Death After COVID Shot Is Under Investigation

Los Angeles Times reported:

Any reports of death following the administration of vaccines are also investigated by the U.S. Food and Drug Administration and Centers for Disease Control and Prevention. The agencies work with healthcare providers to obtain medical histories and clinical follow-up information as part of their probe, FDA spokeswoman Abby Capobianco wrote in a statement. “It is important to note that report of an adverse event is not documentation that a vaccine caused the event,” she added.

Without any concrete answers, Zook’s family is hoping that public health agencies and the pharmaceutical companies who developed the vaccines will conduct more research to reduce any adverse effects of the vaccine.

“We want to urge and push the pharmaceutical companies to look into his death and do some more research,” said Ken Polanco, Rochelle Zook’s cousin. “If we can save one life then it’s worth it.”

Why Has Germany Advised Against Oxford/Astrazeneca Jab for Over-65s?

The Guardian reported:

The issue boils down to a lack of data on efficacy of the vaccine in this age group. The standing committee on vaccination of the Robert Koch Institute, Germany’s disease control agency, said: “There is insufficient data to judge how effective the vaccination is above 65 years.”

Writing in their Lancet study released last year, researchers said there were not enough COVID cases among older adults at the time to explore just how well the vaccine protected them against the disease.

EU Authorizes Oxford-Astrazeneca Coronavirus Vaccine for All Adults

Washington Post reported:

The European Union’s regulator recommended authorization of the Oxford-AstraZeneca coronavirus vaccine for use in the 27-country bloc on Friday, despite a lack of data about efficacy in older people.

European officials had raised concern about the limited knowledge of the vaccine’s effectiveness in older people, who represented only 6 percent of clinical trial participants, though they account for majority of coronavirus deaths and are high on most countries’ vaccination priority lists.

The United States is waiting for further trial data before authorization, and Germany announced on Thursday that it would recommend that the vaccine only be used in adults under 65.

Pain Relievers May Dull Effectiveness of COVID-19 Vaccine, Experts Warn

New York Post reported:

As the US continues to roll out vaccines from both Pfizer/BioNTech and Moderna to the general public, recipients have reported minor side-effects like temporary pain that have driven some to take preventative over-the-counter painkillers before inoculation.

But several experts who spoke with ABC News Wednesday warn that this practice may hinder the body’s ability to form the antibodies that protect against COVID-19.

“We do not recommend premedication with ibuprofen or Tylenol before COVID-19 vaccines due to the lack of data on how it impacts the vaccine-induced antibody responses,” Dr. Simone Wildes, an infectious disease expert and member of Massachusetts’ COVID-19 Vaccine Advisory Group, told the network.

COVID Death Toll at N.Y. State Nursing Homes 50 Percent Higher Than Reported, AG Says

NBC News reported:

Cuomo’s office said Thursday the state followed federal guidance when issuing its order on nursing homes.

Zucker added that “the report’s findings that nursing home operators failed to comply with the State’s infection control protocols are consistent with DOH’s own investigation.”

Asked at a previously scheduled news conference about the attorney general’s report, New York City Mayor Bill de Blasio said, “We have to get the full truth, and we have to make sure it never ever happens again, nothing like this happens again, and we have to be honest about the numbers.”

J&J One-Dose COVID Vaccine Is 66% Effective, a Weapon but Not a Knockout Punch

STAT reported:

Johnson & Johnson said Friday that its single-dose COVID-19 vaccine reduced rates of moderate and severe disease, but the shot appeared less effective in South Africa, where a new coronavirus variant has become common.

Overall, the vaccine was 66% effective at preventing moderate to severe disease 28 days after vaccination. But efficacy differed depending on geography. The shot was 72% effective among clinical trial volunteers in the U.S, but 66% among those in Latin America, and just 57% among those in South Africa. Though markedly below the levels seen with the first two authorized COVID-19 vaccines, those rates are above the thresholds originally set by the U.S. Food and Drug Administration for a vaccine to be considered useful.

The vaccine reduced severe disease alone by 85%, and prevented COVID-related hospitalization or death, Johnson & Johnson said.

***

January 28

Merck Scraps COVID Vaccines, Says It’s More Effective to Get the Virus

Mercola reported:

In a surprising move, Merck has canceled its COVID-19 vaccine trials and is switching to finding a treatment for the virus. The company said their vaccine candidates did so poorly that it would be better to simply get the virus through natural infection.

Their therapeutic drug candidates, however, are faring better they said. “Interim results from a Phase 3 study showed a greater than 50 percent reduction in the risk of death or respiratory failure in patients hospitalized with moderate to severe COVID-19,” the company’s statement noted of the MK-7110 drug.

Cardiothoracic Surgeon Warns FDA, Pfizer on Immunological Danger of COVID Vaccines in Recently Convalescent and Asymptomatic Carriers

The Defender reported:

In a letter to the U.S. Food and Drug Administration (FDA), Pfizer and the press, Dr. Hooman Noorchashm warns of an “almost certain immunological prognotication that if viral antigens are present in the tissues of subjects who undergo vaccination, the antigen specific immune response triggered by the vaccine will target those tissues and cause tissue inflammation and damage.

Noorchashm, M.D., Ph.D., is a physician-scientist and advocate for ethics, patient safety and women’s health. He specializes in cardiothoracic surgery and has taught and practiced medicine for nearly two decades.

“Dr. Noorchashm’s prognostications of harm in elderly individuals with cardiovascular disease coincides with the numerous reports of unexplained  cardiovascular deaths following COVID-19 vaccination in Norway, Germany, the UK, Gibraltar and the U.S.,” said Lyn Redwood, RN, MSN, director and president emerita of Children’s Health Defense.

Did CDC Deliberately Mislead Public on Allergic Reactions to Moderna Vaccine?

The Defender reported:

The CDC’s choice to use VAERS data to calculate the rate of anaphylaxis associated with Moderna’s vaccine is idiosyncratic and troubling. Why?

First, VAERS is a “passive” reporting system, which results in a high degree of underreporting. In fact, a 2010 study (Lazarus et al, 2010) commissioned by the CDC, concluded that “fewer than 1% of vaccine injuries” are reported to VAERS. A 2015 study (Shimabukuro et al, 2015) similarly concluded that vaccine adverse events are underreported.

The other problem with VAERS? Reports often get filed only weeks or months after the event, which means the data is not current.

There are other reporting systems that the CDC could have used to calculate anaphylactic reactions to Moderna’s vaccine.

Amid Sputtering COVID-19 Vaccine Rollout, 16 States Have Used Less Than Half of Distributed Doses

USA TODAY reported:

West Virginia Gov. Jim Justice said the CDC figures low-balled his state’s vaccine distribution. The agency reported the state had distributed nearly 77% of doses as of Wednesday; 9.5% of West Virginians have received at least one vaccine shot, a higher rate than all but Alaska’s 11.4%.

Justice said the state generally administers vaccine the same week it receives doses. The state has employed the West Virginia National Guard and partnered with 250 local and independent pharmacists to administer vaccines in clinics rather than relying on national chains CVS and Walgreens like other states.

“You can’t leave this stuff on a warehouse shelf – you’ve got to move,” Justice told USA TODAY.  “Every shot we’re getting in someone’s arm is a real shot we are saving someone’s life.”

To Promote Vaccines, New Orleans Dances With Its Heart on Its Sleeve

New York Times reported:

The advertisement is one of numerous efforts around the country to persuade people of the importance of getting a Covid shot. But its homegrown approach, using neighborhood personas and invoking local culture with “laissez les bons temps rouler” dance moves and costumes, may make it particularly effective, say experts in vaccine hesitance and behavioral change.

“I’m getting the vaccine so we can have Mardi Gras, y’all!” shouts Jeremy Stevenson, a Monogram Hunter Mardi Gras Indian, also known as Second Chief Lil Pie, as he sways wildly in a 150-pound, 12-foot-tall tower of turquoise feathers and beading, beneath the Claiborne Avenue overpass, a well-known festival meet-up.

Other locals prance forth to offer their own reasons, concluding with the tagline: “Sleeves Up, NOLA!”

Oklahoma Schools Turning to 3rd-Party Vaccine Administrators

FOX25 reported:

Canadian County schools have announced they will be administering COVID-19 vaccinations via third party.

Superintendent Craig McVay of El Reno Public Schools says his school will be using Passport Health to vaccinate the district’s 400 employees.

McVay anticipates the vaccines will be administered in February.

***

January 27

Worries About Vaccine Deaths, Injuries Aren’t Slowing Down

The Final Call reported:

Reports of deaths and injuries associated with or suspected to be caused by the experimental COVID-19 vaccines are coming in from across the United States and other parts of the world.

Baseball legend Hank Aaron’s passing came suddenly as the 86-year-old Hall of Famer’s death was announced Jan. 22. CNN reported that Mr. Aaron died in his sleep, and no cause of death was given.

Mr. Aaron, joined by several Black leaders, did receive the Moderna vaccine earlier in January at the Morehouse School of Medicine. He told the Associated Press taking the vaccine was his way of trying to help “zillions of people in this country.”

Healthcare Worker Dies 4 Days After Second Pfizer Vaccine, Death Under Investigation

The Defender reported:

Tim Zook, an x-ray technologist at South Coast Global Medical Center in Santa Ana, was hospitalized on Jan. 5, several hours after being vaccinated. Zook’s wife, Rochelle Zook, told the Orange County Register that her husband’s health rapidly deteriorated over the next few days. He died Jan. 9.

Rochelle Zook said her husband believed in vaccines, and that she didn’t blame “any pharmaceutical company” for his death. She also said:

“But when someone gets symptoms 2 1/2 hours after a vaccine, that’s a reaction. What else could have happened? We would like the public to know what happened to Tim, so he didn’t die in vain. Severe reactions are rare. In reality, COVID is a much more deadly force than reactions from the potential vaccine itself.”

Inclusion of Pregnant and Lactating Persons in COVID-19 Vaccination Effort

Annals of Internal Medicine reported:

As the U.S. Food and Drug Administration issues emergency use authorizations for vaccines, the Advisory Committee on Immunization Practices is issuing recommendations about who should receive the vaccine and their priority for receipt (1).

It is important to recognize where pregnant persons fit into this national framework.

Health care workers, of whom as many as 300 000 may be pregnant, are in the highest-priority tier for vaccination and are currently being vaccinated. The next wave of vaccinations will be offered to persons with medical conditions, many of whom may also be pregnant.

CDC’s Vaccine Injury Reporting System ‘Temporarily’ Down

The Defender reported:

Anyone hoping to find the latest information on vaccine injuries that have been reported to the Centers for Disease Control and Prevention (CDC) is out of luck, at least temporarily.

The CDC’s Vaccine Adverse Event Reporting System (VAERS) allows the public to search the database of vaccine injuries reported to the system. Visitors to the site can search by a number of criteria, including type of injury and vaccine product.

When The Defender reached out to the CDC’s media department to find out why the system is down, and when it’s expected to be working again, we got a recording that said the media department was experiencing an “unusually high volume of calls,” and that callers should “hang up and try again later.”

Anyone who suspects they’ve been injured by a vaccine can still report the injury here — the reporting part of the VAERS website is still working. Children’s Health Defense also asks that people report injuries to VaxxTracker and file a report on the CHD website.

CDC Says Risk of Coronavirus in Schools Is Small

The Hill reported:

New research published Tuesday by the U.S. Centers for Disease Control and Prevention (CDC) suggests the risk of COVID-19 spread in classrooms is relatively low, adding new questions over the continued closure of in-person education across the nation.

Attending close social gatherings or interacting with members outside of their households was a leading cause of infection, but in-person school attendance was not.

Similar results were recorded when examining 11 school districts in North Carolina, featuring 90,000 students and staff occupying school classrooms for nine weeks.

Vaccine Rollout Stumbles as a ‘Hunger Games’ Approach Leaves States and Counties to Fend for Themselves

CNN reports:

Eighty-year-old Belma Requejo of Los Angeles County is trapped in her home with her 83-year-old husband and two other elderly relatives.

They are waiting for a coronavirus vaccine. Every day for a week, her daughter, Maria — who lives in the same household with her two children — has tried to get on the county’s website to make an appointment. And every time, Maria is told there is no availability.

Meanwhile, COVID-19 has ravaged their densely populated section of Long Beach; just last week the disease claimed the life of a neighbor.

***

January 26

Fauci Says Drop in COVID Cases Not Due to Vaccine: ‘We Don’t Want to Get Complacent’

NBC News reported:

Dr. Anthony Fauci on Monday said that a drop in COVID-19 cases and hospitalizations in most of the country cannot likely be attributed to vaccines, meaning people should continue to be as cautious as possible.

“I don’t think the dynamics of what we’re seeing now with the plateauing is significantly influenced, yet — it will be soon — but yet by the vaccine,” Fauci, director of the National Institute of Allergy and Infectious Diseases, said on NBC’s “TODAY” show.

The chief medical adviser to the president said the drop was more likely due to a natural plateauing of cases following a spike after the holiday season.

Oklahoma Children Participate in COVID-19 Vaccine Trial

KTUL News reported:

An Oklahoma City laboratory is one of just a few locations nationwide testing the COVID-19 vaccine on children.

The Lynn Health Science Institute says these studies are vital to ending the pandemic.

This week, kids as young as 12 were given a shot in the arm and a shot at immunity from COVID-19.

The vaccine is not currently FDA approved for anyone younger than 18, but these kids, with their parent’s permission, are part of the process to push the vaccine forward.

Caution Needed in Using mRNA-Based Vaccines to Prevent Unknown Risks Including Death

Global Times reported:

The large-scale use of mRNA-based COVID-19 vaccines including those produced by Pfizer and Moderna may contain unknown risks, Chinese experts warned, and called for the cautious use of such vaccines following the death of a patient in the US.

Unlike inactivated vaccines, the large-scale use of mRNA vaccines carries the risk of causing abnormal immune dysfunction, allergy or even death especially among the elderly and people with underlying diseases, the Chinese immunologist said, while some observers call for more investigation over the death before drawing a conclusion that mRNA vaccines are unsafe.

The patient, from Placer county, California, died hours after receiving a coronavirus vaccine, triggering concerns over the safety of mRNA vaccines, despite Placer county officials rejecting the link between the person’s death and the vaccine, KTLA reported.

Health Departments Battle Vaccine Concerns

KOMU reported:

“I couldn’t help but notice, also, there was a lot of conversation on social media about vaccines, but in particular, the HPV vaccine,” Dr. Luisi said.

From there she posed the question of if there was a relationship between what was happening on social media and the way the HPV vaccine was perceived.

And Facebook seemed to have her answer. She found that nearly 40% of posts focused on the risks of the HPV vaccine.

“Particularly posts that were talking about the risk of the vaccine, like the vaccine being dangerous, were receiving significantly greater engagement,” she said. “And they were also the ones that had momentum for being shared as well.”

Pet Cats and Dogs May Need Their Own COVID Vaccine, Scientists Suggest

Evening Standard reported:

A separate rollout to vaccinate pet cats and dog against COVID-19 may be necessary in the future to curb the spread of the virus, scientists have suggested.

As the government racked up nearly 7 million jabs for the UK population, experts said it was “not unthinkable” that domestic animals who are able to contract the virus might need to receive a jab to help bring the virus under control.

Coronavirus can infect a wide range of species, including cats, dogs and mink, experts from the University of East Anglia (UEA), Norwich-based research facility the Earlham Institute and the University of Minnesota have said.

In an editorial for the journal Virulence, they wrote that continued evolution of the virus in animals followed by transmission to humans “poses a significant long-term risk to public health”.

Vaccine Tourism on the Rise as Wealthy International Tourists Eye an Opportunity in the U.S.

NBC News reported:

Shortly before the COVID-19 vaccine made its debut last month in the United States, an Indian travel agency called Gem Tours & Travels announced it was registering customers for an exciting new package: a four-day trip from Mumbai to New York City with a coronavirus shot thrown in for about $2,000.

“Vaccine tourism,” Nimesh Shah, the company’s business development specialist, called it.

“We are only taking registrations of Indians with a valid 10-year U.S. visa,” Shah told ThePrint. “We are not taking any money but just collecting data for the moment. We are proud to have coined the term ‘vaccine tourism.’”

Soon, competitors like the Kolkata-based Zenith Holidays were registering customers for vaccination packages.

Pronab Sarkar, president of Indian Association of Tour Operators, condemned the companies for peddling these junkets. But Zenith Holidays, which generally does not offer travel packages to the U.S., still has on its website a “Vaccine Tourism“ tab where customers can fill out a registration form, click send, and within minutes an email from the company pops up in their inbox promising more information soon.

Budweiser Joins Coke, Pepsi Brands in Sitting Out Super Bowl, Shifting Money to Vaccine Awareness

Wisconsin News reported:

But the decision to not do an anthemic Budweiser ad — which over nearly four decades has made American icons of frogs chirping “Budweiser,” guys screaming “Whassup!”, and of course the Budweiser Clydesdales — showcases the caution with which some advertisers are approaching the first COVID-era Super Bowl.

“We have a pandemic that is casting a pall over just about everything,” said Paul Argenti, Dartmouth College professor of corporate communication. “It’s hard to feel the exuberance and excitement people normally would.”

The Anheuser-Busch move follows a similar announcement from PepsiCo., which won’t be advertising its biggest brand, Pepsi, in order to focus on its sponsorship of the halftime show. (It will be advertising Mountain Dew and Frito-Lay products). Other veteran Super Bowl advertisers like Coke, Audi and Avocados from Mexico are sitting out the game altogether.

Regeneron Pitches COVID-19 Antibody Cocktail for ‘Passive Vaccination’ With Fresh Trial Data

FiercePharma reported:

As the demand for COVID-19 vaccines from Moderna, Pfizer and AstraZeneca continues to outstrip supply and alternative vaccines struggle to make it out of the pipeline, the world is desperate for new ways to end the pandemic. Regeneron says it’s offering a potential solution.

The New York-based biotech released preliminary data from an ongoing phase 3 trial of its antibody cocktail REGEN-COV in people at high risk of contracting COVID-19 because of exposure to family members with the disease. The results justify using the drug for “passive vaccination,” the company said today.

REGEN-COV was 100% effective at preventing symptoms of COVID-19 in the trial as compared to placebo, the company announced. Passive vaccination with the drug slashed the overall rate of infection by half. All the infections that did occur among trial participants on the drug were asymptomatic, lasted no more than one week and showed a “short duration” of the viral shedding that can drive the illness to other people, Regeneron said.

***

January 25

Pfizer Says COVID-19 Vaccine Trial in Children Between 12-15 Is Fully Enrolled

Reuters reported:

Pfizer Inc. says trial testing its COVID-19 vaccine in children between 12-15 is fully enrolled with more than 2,000 participants.

California Man Dies Several Hours After Receiving COVID Vaccine, Cause of Death Unclear

The Defender reported:

Multiple local, state and federal agencies are investigating the Jan. 21 death of a California man several hours after receiving the COVID vaccine.

Placer County Sheriff’s office said in a Jan. 23 Facebook post that agencies are “actively investigating this case.” They also mentioned that the man had tested positive for COVID in December. The U.S. Centers for Disease Control and Prevention (CDC) recommends that individuals who have already had COVID and fully recovered should still get vaccinated.

Merck Shuts Down Covid Vaccine Program After Lackluster Data

Bloomberg reported:

Merck & Co. is discontinuing development of its two experimental COVID-19 vaccines after early trial data showed they failed to generate immune responses comparable to a natural infection or existing vaccines.

The U.S. drug giant, which has a history of successfully developing vaccines, had adopted a different strategy from rivals Pfizer Inc., Moderna Inc. and Johnson & Johnson, using a more traditional approach of focusing on shots based on weakened viruses. One, called V590, borrowed technology from Merck’s Ebola inoculation, while the other, V591, is based on a measles vaccine used in Europe.

Vaccinated People May Spread Virus, Says Van-Tam

BBC reported:

Writing in the Sunday Telegraph, Prof Jonathan Van-Tam stressed that scientists “do not yet know the impact of the vaccine on transmission.”

He said vaccines offer “hope” but infection rates must come down quickly.

Matt Hancock said 75% of over-80s in the UK have now had a first virus jab.

Both the Pfizer-BioNTech and Oxford-AstraZeneca vaccines require two doses, and figures so far reflect those given the first dose.

The health secretary told the BBC’s Andrew Marr that around three quarters of care homes had also been vaccinated.

Bills for COVID-19 Vaccine Religious Exemptions for Children Don’t Pass Virginia Senate Committee

Wavy.Com reported:

Two Virginia bills that would have allowed a parent or guardian to refuse a COVID-19 vaccine for their child citing religious practices will not advance.

The Senate Education and Health Committee killed the two bills Thursday morning.

The bills, SB 1116 and SB 1117 would have allowed the refusal of the COVID-19 vaccine even if an emergency or epidemic was declared by the State Board of Health.

Under current law, the only exception to the State Health Commissioner’s power to require immediate immunization of all persons in case of an epidemic of any disease of public health importance for which a vaccine exists is for a person to whose health the administration of a vaccine would be detrimental as certified in writing by a physician licensed to practice medicine in the Commonwealth.

CDC Recommends Against Getting Other Vaccines Close to When You Get the COVID-19 Vaccine

WGNTV Chicago reported:

If you’re going to get the COVID-19 vaccine, some health experts want to make sure you’re not getting another vaccine too close together.

A health official said there are too many unknowns about the side effects of the COVID-19 vaccine being administered right before or after another vaccine, such as the flu or shingles shot.

“The current CDC recommendation is 14 days to wait between receiving different vaccines. This is not a hard stop, though. It’s simply a recommendation,” Heather Wright, an infection preventionist at SSM Health St. Joseph Hospital in Missouri, said.

Care Homes Consider Legal Challenge to Force Their Workers to Take Vaccine

The Times reported:

Care providers are seeking legal advice over whether they can force staff to have a coronavirus jab, as a poll reveals some young people are shunning vaccines.

The National Care Association has taken the unprecedented step of seeking a legal opinion on whether care home workers can be made to accept vaccination after thousands refused. Between 6% and 8% of the 1.5 million adult social care workforce in England are declining jabs, despite the number of coronavirus cases in care homes trebling in the past month, according to industry reporting of uptake across the country.

Moderna Says It’s Working on COVID Booster Shot for Variant in South Africa, Says Current Vaccine Provides Some Protection

CNBC reported:

Moderna said Monday it’s accelerating work on a COVID19 booster shot to guard against the recently discovered variant in South Africa.

The company’s researchers said its current coronavirus vaccine appears to work against the two highly transmissible strains found in the U.K. and South Africa, although it looks like it may be less effective against the latter.

The two-dose vaccine produced an antibody response against multiple variants, including B.1.1.7 and B.1.351, which were first identified in the U.K. and South Africa, respectively, according to a Moderna study conducted in collaboration with the National Institute of Allergy and Infectious Diseases. The study has not yet been peer reviewed.

Fauci Said Second COVID-19 Vaccine Shot Knocked Him Out for 24 Hours

The Hill reported:

The nation’s top infectious diseases expert Anthony Fauci told reporters on Thursday that the second round of the COVID-19 vaccine knocked him out for 24 hours.

“I did. I had it on the 19th. I was hoping that I wouldn’t get too knocked out. I did for about 24 hours. Now I’m fine,” Fauci said after he was asked if he received the second dose of the vaccine at a White House event.

“Fatigued. A little achy. You know. Chilly. Not sick,” Fauci clarified.

The second dose of the COVID-19 vaccine can leave people feeling tired and achy. Other symptoms include chills and a fever.

Pfizer COVID-19 Vaccine Has Caused Life-Threatening Allergic Reactions in 21 Americans, Report Shows

StudyFinds reported:

The Pfizer COVID-19 vaccine comes in two doses, but a new report reveals nearly two dozen Americans suffered serious allergic reactions before making it to their second shot.

The study in JAMA warns that patients with a history of allergies to foods, animals, insect stings, or medical products should be observed for up to 30 minutes after receiving the vaccination. Study authors advise that plenty of epinephrine, the gold standard in treating allergic attacks, should also be on hand at vaccination sites.

The Centers for Disease Control and Prevention (CDC) identified 21 cases of anaphylaxis among almost 1.9 million people getting their first dose of the Pfizer drug.

Dr. Tom Shimabukuro and Dr. Narayan Nair say four people had to be hospitalized for an allergic reaction to the vaccine. Three of the patients ended up in the intensive care unit. The other 17 experiencing a reaction received treatment in local emergency departments and released.

“Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours,” the study authors write in their report.

CDC Quietly Changes COVID Vaccine Guidance to Ok Mixing Pfizer and Moderna Shots in ‘Exceptional Situations’

CNBC reported:

The Centers for Disease Control and Prevention quietly changed its guidance on Covid-19 vaccine shots, saying it’s now OK to mix Pfizer’s and Moderna’s shots in “exceptional situations” and that it’s also fine to wait up to six weeks to get the second shot of either company’s two-dose immunization.

While Pfizer’s and Moderna’s vaccines, which both use messenger RNA technology, were authorized to be given 21 and 28 days apart, respectively, the agency now says you can receive either shot so long as they are given at least 28 days apart, according to new guidance posted Thursday on its website.

FEMA Would Operate up to 100 Federally Run Mass Vaccination Sites Under Biden Plan

Washington Post reported:

Enlisting FEMA, an agency of the Department of Homeland Security, is among the clearest signals that Biden intends to involve the federal government more directly in the administration of vaccines, instead of leaving the final step of the massive effort to state and local authorities.

“FEMA … will mobilize thousands of clinical and nonclinical staff and contractors who will work hand-in-glove with the National Guard and state and local teams to assist, augment, and expedite the distribution and administration of coronavirus vaccines,” the FEMA document states.

If requested by states and other jurisdictions, the draft notes, “the U.S. Government would develop, equip, provide information management, and staff and operate the site.”

***

January 22

Fauci Says New Data Shows COVID Vaccines Appear to Be Less Effective Against Some New Strains

CNBC reported:

New data shows that the COVID-19 vaccines currently on the market may not be as effective in guarding against new, more contagious strains of the coronavirus, White House health advisor Dr. Anthony Fauci said on Thursday.

A handful of new strains of the coronavirus have emerged overseas that have given scientists some cause for concern. Some variants that have been identified in the United Kingdom, South Africa and Brazil appear to be more transmissible than previous strains but not necessarily more deadly.

Home Run King Hank Aaron Dies of ‘Undisclosed Cause’ 18 Days After Receiving Moderna Vaccine

The Defender reported:

Baseball legend Hank Aaron, who received the Moderna COVID vaccine on Jan. 5, has died. According to the New York Times, the Atlanta Braves confirmed the 86-year-old Hall of Famer’s death today, but did not provide further details.

CNN reported that Aaron died “peacefully in his sleep,” and that no cause of death was disclosed.

Aaron made headlines earlier this month when he was photographed getting the Moderna vaccine. He told the Associated Press at the time that getting vaccinated “makes me feel wonderful.” He added:

“I don’t have any qualms about it at all, you know. I feel quite proud of myself for doing something like this. … It’s just a small thing that can help zillions of people in this country.”

Recipients Testing Positive in Israel Sparks Concern Over Pfizer Vaccine Efficacy

Global Times reported:

More than 12,400 in Israel were reportedly infected after accepting Pfizer’s COVID-19 vaccine, which led to doubts over the vaccine’s efficacy, despite the reported 95 percent efficacy in Phase III clinical trials.

This can be a sign that the vaccine’s efficacy is not necessarily the same as data from experiments, which is affected by many elements such as the experiment environment and the population tested on, some experts said.

More importantly, experts warned that a vaccine is not a panacea. The public should learn that the most effective way is wearing masks and protective suits, they said.

Door to Door in Miami’s Little Havana to Build Trust in Testing, Vaccination

Kaiser Health News reported:

But during the pandemic, a group called Healthy Little Havana is zeroing in on this area with a very specific assignment: persuading residents to get a coronavirus test.

The group’s outreach workers have been heading out almost daily to walk the quiet residential streets, to persuade as many people as possible to get tested for COVID-19. On a recent afternoon, a group of three — Elvis Mendes, María Elena González and Alejandro Díaz — knocked on door after door at a two-story apartment building. Many people here have jobs in the service industry, retail or construction; most of them aren’t home when visitors come calling.

Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine

JAMA reported:

Notifications and reports of suspected severe allergic reactions and anaphylaxis following vaccination were captured in the Vaccine Adverse Event Reporting System (VAERS), the national passive surveillance (spontaneous reporting) system for adverse events after immunization. Physicians at the US Centers for Disease Control and Prevention (CDC) evaluated these reports and applied Brighton Collaboration case definition criteria to classify case reports as anaphylaxis or not anaphylaxis. Non-allergic adverse events, mostly vasovagal or anxiety-related, were excluded from the analysis. Anaphylaxis and non-anaphylaxis allergic reaction cases with symptom onset occurring later than the day after vaccination were also excluded because of the difficulty in clearly attributing allergic reactions with delayed onset after vaccination. Because the Moderna COVID-19 vaccine was only available beginning December 21, 2020, this article focuses on the Pfizer-BioNTech COVID-19 vaccine.

How Many Vaccine Shots Go to Waste? Several States Aren’t Counting.

ProPublica reported:

Jha said he thinks that the true number of wasted doses across the country is far higher than a handful. After he detailed one anecdote he heard about an ER physician forced to waste vaccine doses in a thread on Twitter, his phone quickly filled with more than a dozen messages from other medical workers, confirming what he suspected: At a time when the U.S. is desperately short on vaccines, a significant number of doses are ending up in the trash.

Clinics and hospitals have “gotten slammed” when the media has learned of them wasting even a few doses, he said. “And the signal to everybody else is, if you have waste, don’t report it. Because if you do, you’re gonna get into a lot of trouble. That combination means, at least in my assessment, there’s a lot of waste and a lot of underreporting of that waste.”

Blaze at Facility of World’s Biggest Vaccine Maker Kills 5 People

CNN reported:

A fire that broke out at a facility of the world’s biggest vaccine maker that killed five people would not affect vaccine production, the head of the company said Thursday.

The blaze at the Serum Institute of India (SII) in the western city of Pune was brought under control on Thursday though the cause is still under investigation, according to Murlidhar Mohol, the city’s mayor.

Four people were rescued from the six-floor building but five others died, Mohol said. They are believed to have been construction workers as the building was still under construction at the time of the fire.

***

January 21

Senator Files Bill to Repeal Oklahoma School Vaccination Laws

McAlester News reported:

Oklahoma requires vaccinations before children can attend any school with some exemptions, but a state senator wants to stop vaccination requirements altogether.

District 7 State Sen Warren Hamilton, R-McCurtain, filed Senate Bill 350 to repeal Oklahoma’s School Vaccination Laws and prohibit vaccination requirements as a condition of admittance to any school.

“As a parent, you or I are responsible for our child’s health, not necessarily the school,” Hamilton said. “If the school wants to offer those things, I think that’s fantastic. If the school wants to mandate those things, then that’s not.”

Florida Bill Would Protect People From Being Discriminated Against Based on Vaccine Status

Stand for Health Freedom reported:

Senator Joe Gruters (D 23) filed SB364 to protect Floridians from facing discrimination based on their vaccination decisions. This is one of the most important bills of our time and needs your support today.

In the middle of nonstop media coverage of coronavirus and intense public pressure from government and community leaders, many people are wondering if they will be forced to get the COVID-19 vaccine to keep their job or source of income.

There are numerous reasons why someone might choose to decline the vaccine. Among the most common are conscientious objections, religious convictions, a history of prior vaccine injury and concerns over safety, including the lack of short and long-term safety data.

Moderna Says It’s Safe to Use a Huge Lot of Moderna Vaccines Paused After Allergic Reactions

San Francisco Chronicle reported:

California is releasing hundreds of thousands of doses of coronavirus vaccine that it had put on pause Sunday after the vaccine batch was linked to a cluster of allergic reactions in San Diego last week.

The matter was examined by the state committee that reviews coronavirus vaccine safety and other agencies, according to state health officer Dr. Erica Pan.

“Yesterday, we convened the Western States Scientific Safety Review Workgroup and additional allergy and immunology specialists to examine the evidence collected,” the California Department of Public Health said in a statement Wednesday night. “We had further discussions with the County of San Diego Department of Public Health, the FDA, CDC and manufacturer, and found no scientific basis to continue the pause. Providers that paused vaccine administration from Moderna Lot 41L20A can immediately resume.”

Brits Told Not to Hug Kids Amid Fears Millions Will Ignore COVID Rules Once They Have Jab

Evening Standard reported:

Britons should not hug their children even once they’ve been vaccinated, an expert has stressed, amid warnings that millions are likely to begin ignoring coronavirus lockdown rules once they have had the jab.

Scientists have expressed concern that recipients of a Covid-19 vaccine will feel more relaxed about social distancing, which could “offset” the benefits of the national vaccination programme.

Asked whether people who had received the jab could hug their children, Janet Lord, director of Birmingham University’s Institute of Inflammation and Ageing, said: “I would certainly advise not to do that at the moment because as you probably know with the vaccines they take several weeks before they are maximally effective.”

All Overweight D.C. Residents Will Get Priority for the Coronavirus Vaccine. Experts Are Skeptical.

Washington Post reported:

The District plans to give priority for coronavirus vaccines to the broadest possible swath of people with preexisting health conditions — a decision that will make hundreds of thousands eligible for scarce doses of the vaccine and that some public health experts say might not make medical sense.

The plan, the details of which were confirmed by vaccine director Ankoor Shah, would offer vaccines to people whose weight and medical history would not qualify them for early access to the vaccine in almost any state in the country.

D.C. Health Director LaQuandra Nesbitt told members of the D.C. Council last week that she made the decision to open up vaccine access, possibly as soon as February, to such a large group in the hope of quickly vaccinating anyone who might suffer the worst outcomes if they contract the virus.

Fire Hits Building at Indian Producer of COVID-19 Vaccines

ABC New reported:

PUNE, India — At least five people were killed in a fire that broke out Thursday at a building under construction at Serum Institute of India, the world’s largest vaccine manufacturer, officials said. The company said the blaze would not affect production of the COVID-19 vaccine.

Murlidhar Mohol, mayor of Pune city in southern Maharashtra state, said five bodies were found in the rubble after the flames were extinguished by firefighters.

Read the Full Letter Amazon Sent to Biden Offering to Help With COVID-19 Vaccines

NBC News reported:

Amazon on Wednesday offered to help with the national effort to distribute the COVID-19 vaccine, according to a letter addressed to President Joe Biden, which was obtained by CNBC.

“As you begin your work leading the country out of the COVID-19 crisis, Amazon stands ready to assist you in reaching your goal of vaccinating 100 million Americans in the first 100 days of your administration,” Dave Clark, CEO of Amazon’s worldwide consumer business, wrote in the letter, which was first reported on by Reuters.

Clark said Amazon stands ready to leverage its operations, information technology and communications capabilities and expertise to “assist your administration’s vaccination efforts.” He added that Amazon has reached an agreement with a third-party health-care provider to administer vaccines on site at the company’s warehouses.

The letter comes as Amazon has been vying for its front-line workers to have priority access to the COVID-19 vaccine.

***

January 21

Moderna Says Possible Allergic Reactions to COVID Vaccine Under Investigation

Reuters reported:

“A higher-than-usual number of possible allergic reactions were reported with a specific lot of Moderna vaccine administered at one community vaccination clinic. Fewer than 10 individuals required medical attention over the span of 24 hours,” the epidemiologist said in a statement here.

The vaccine maker said it was unaware of comparable cases of adverse events from other vaccination centers which may have administered vaccines from the same lot or from other lots of its vaccine.

COVID Vaccines May Need Updating to Protect Against New Variant, Study Suggests

The Guardian reported:

Coronavirus vaccines may need to be redesigned this year to boost protection against a new variant that emerged rapidly in South Africa, research suggests, while past COVID sufferers may not be protected against reinfection.

Research by South African government scientists reveals that mutations of the new variant, known as 501Y.v2 or B1351, make the variant substantially resistant to antibodies in blood plasma donated by COVID patients.

The findings suggest it may be more likely to reinfect people who have already had COVID, and that vaccines being rolled out across the globe may be less effective. Since the variant emerged late last year, it has prompted travel bans around the world.

More Than 4,000 Vaccine Doses Sent to Maine Potentially Spoiled Because of Temperature Issues

Portland Press Herald reported:

More than 4,000 doses of COVID-19 vaccine delivered to Maine clinics this week were set aside and not given to patients because the boxes became too warm during shipping, officials said Tuesday.

Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, said 35 of 50 sites in Maine that accepted shipments of Moderna vaccines on Monday received boxes that displayed a red checkmark, a sensor indicating that internal temperatures exceeded the  safety threshold at some point while in transit. The Moderna vaccine is shipped in containers at minus 4 degrees Fahrenheit.

As a result, the Maine CDC instructed clinics not to administer the 4,400 doses to individuals. Additional doses to replace those that were set aside were expected to arrive Tuesday and Wednesday, Shah said.

Elderly Begin to Drop Out of Novavax Vaccine Trial to Get Pfizer and Moderna Shots

Washington Post reported:

We hope Novavax vaccine will not be derailed by the fact that subjects in the trial would leave the trial to get access to a known vaccine,” Moncef Slaoui, the chief scientific adviser to Operation Warp Speed, said last week at a JP Morgan conference. Novavax and the Food and Drug Administration, which oversees trials, say they remain hopeful the Novavax study can achieve full recruitment.

It is the latest in a series of challenges for Novavax, a Maryland biotechnology company that in July received $1.6 billion in federal taxpayer money via Operation Warp Speed development and manufacturing contracts. Earlier in the year it received nearly $400 million from the Coalition for Epidemic Preparedness Innovations (CEPI), a Norway-based nonprofit that supports global vaccine development.

Nearly 12,000 COVID-19 Vaccine Doses Ruined on Way to Michigan

New York Post reported:

Almost 12,000 doses of Moderna’s COVID-19 vaccine were spoiled en route to Michigan because they got too cold, state health officials said.

Twenty-one shipments of the vaccine – or 11,900 doses — sent Sunday by a Texas-based distributor, McKesson Corporation, were deemed unusable after falling below the federally recommended range of minus 13 degrees to 5 degrees Fahrenheit.“Although it is unfortunate that this vaccine will not be able to be used, we are pleased that the safeguards put into place to ensure the integrity of the vaccine worked,” the state’s chief medical executive, Dr. Joneigh Khaldun, said in a statement.

***

January 19

All 4 Nurses in a Kansas County’s Health Department Refused to Give Out COVID-19 Vaccines

Business Insider reported:

All four nurses working in the health department of Coffey County in Kansas said they wouldn’t give people the COVID-19 vaccine, a sign of how misinformation about the shots is spreading even among health professionals.

In a January 4 county commission meeting, health department administrator Lindsay Payer said that they were not willing to give the COVID-19 vaccine, The Daily Beast reported.

“My staff is not comfortable with that. It’s a new technology we’ve never seen before,” Payer told the Board of Commissioners in the meeting, which is available on YouTube.

Developer of India’s Controversial COVID-19 Vaccine Warns Some to Avoid the Shot

Los Angeles Times reported:

The company that developed India’s controversial homegrown COVID-19 vaccine is warning people with weak immunity and other medical conditions, such as allergies, fever and bleeding disorders, to consult a doctor before getting the inoculation — and, if possible, to avoid it altogether.

The company, Bharat Biotech, said Tuesday that those receiving COVID-19 vaccinations should disclose their medical condition, medicines they are taking and any history of allergies. It said severe allergic reactions among vaccine recipients may include difficulty breathing, swelling of the face and throat, rapid heartbeat, body rashes, dizziness and weakness.

Bharat Biotech’s vaccine, Covaxin, ran into controversy after the Indian government allowed its use without disclosing concrete data showing its effectiveness in preventing COVID-19. Tens of thousands of people have been given the shot in the past three days after India started immunizing healthcare workers over the weekend in one of the world’s largest mass-vaccination campaigns.

Dr. Scott Gottlieb Estimates Only About 120 Million People in U.S. Really Want COVID Vaccine

CNBC reported:

Dr. Scott Gottlieb told CNBC on Tuesday the rollout of COVID vaccines in the U.S. may eventually be slowed by not enough people wanting to receive the shot.

While the incoming Biden administration will initially be focused on increasing access to vaccines, Gottlieb said public-health efforts also must combat concerns held by some Americans.

“I think we need to also …. work on the demand side of this equation. We can’t lose sight of that and just take for granted that everyone wants this vaccine,” the former Food and Drug Administration commissioner said “Squawk Box.”

Tens of Thousands Skip India’s COVID Vaccination Drive

Al Jazeera reported:

India has stepped up efforts to bolster trust in coronavirus vaccines after it was revealed that nearly one-third of those invited to receive the vaccine at the launch of a nationwide drive failed to turn up.

The government confirmed late on Monday that two post-vaccination deaths had been reported. One was a 52-year-old man who the health ministry said died on Saturday in the northern state of Uttar Pradesh from “cardiopulmonary disease” and not the injection.

A post-mortem is being conducted on a 43-year-old man in Karnataka state who suffered a heart attack.

The government said that over the first three days of vaccinations, 580 people had reported adverse symptoms.post-vaccination deaths had been reported.

A Nursing Home Network Is Offering Cash Bonuses to Employees Who Get a COVID-19 Vaccination. How Effective Are Such Incentives?

Chicago Tribune reported:

Some studies have shown that incentivizing vaccines can increase participation, but some experts are wary of the practice. At least one Texas health system is offering a similar cash bonus, paying workers a $500 bonus for choosing to become vaccinated, according to news reports, and Chicago Public Health Commissioner Allison Arwady at a City Council hearing on Wednesday threw out the idea of giving stipends to health care workers as an incentive to boost vaccine rates, though a health department spokesman said there are no immediate plans to do this.

Overall, employers and governmental agencies are looking for ways to assure the public that the COVID-19 vaccines are safe, often using educational tools and publicizing vaccines taken by high-profile people to show that the shot is safe. A Chicago bar is even offering $10 gift cards to those who show proof of inoculation.

Washington State Taps Starbucks for Help With COVID Vaccine Rollout

NBC News reported:

Starbucks has assigned 11 employees with expertise in labor and deployment, operations, and research and development to work full time on vaccine distribution in its home state, the company said, adding that the number of employees could change.

Inslee said the state is also arranging for over 2,000 pharmacies to administer vaccinations and setting up drive-by vaccination sites. Microsoft, another Seattle area-based corporation, will also set up a site to perform 5,000 vaccinations a day, he said.

Microsoft Campus Near Seattle Will Be Used to Administer COVID-19 Vaccine

GeekWire reported:

The company will provide both space and support staff to help administer vaccines for Washington residents. Smith said the goal by next month is to have its campus be one of the mass vaccination sites across the state.

“This is not going to be a site for Microsoft employees; this is going to be a site for people in the community,” Smith said.

Smith added that Microsoft is helping reduce the cost of administering vaccines and helping uninsured people get vaccinated.

Supermarket Chain Aldi to Pay U.S. Workers Who Get COVID-19 Vaccination

Reuters reported:

German supermarket chain Aldi on Tuesday became the latest firm in the grocery sector to offer incentives for U.S. employees getting a COVID-19 vaccine, saying it would give up to four hours of pay to those who choose to receive inoculations.

The retailer, which has more than 2,000 stores in 37 U.S. states, said it would cover costs associated with vaccine administration and implement on-site vaccination clinics at its warehouse and office locations.

Small Biotech Launches Human Trials of a Potential ‘Backstop’ for COVID-19 Vaccines

STAT reported:

A small biotechnology firm said that it will start human testing of an experimental COVID-19 vaccine it hopes can target potential strains of the SARS-CoV-2 virus that could evade current vaccines — if such strains ever exist and become a problem.

“We all hope that this will not be necessary,” said Andrew Allen, the CEO of the firm, Gritstone Oncology, in an interview with STAT. “I think it’s prudent to have it developed as a backstop. We all talk about pandemic preparedness. So that’s what this is about.”

“We have a good vaccine that is delivering benefit in the short term, but we need to be ready for scenarios where those vaccines lose effectiveness, because that historically has been seen many times and we should be ready for that and not be caught short again,” Allen said.

COVID-19 Supply Deal Lets Vaccine Maker Earmark Doses For Employees And Their Families

NPR reported:

Operation Warp Speed, the Trump administration’s push to make a COVID-19 vaccine available in record time, added $628 million to a federal contract with Emergent BioSolutions, a Maryland-based contract manufacturer, “to advance manufacturing capabilities and capacity for a potential COVID-19 vaccine as well as therapeutics,” the Department of Health and Human Services announced in June.

The company has also inked separate deals worth hundreds of millions of dollars to manufacture COVID-19 vaccine doses for AstraZeneca, Johnson & Johnson and Novavax, all three of which are part of Operation Warp Speed.

According to Emergent’s federal contract, the company can keep “a reasonable quantity of vaccines” to inoculate its “employees and critical subcontractors, and their respective immediate families.”

***

January 18

Wisconsin Nursing Home Staff Laid Off for Refusing COVID-19 Vaccine

Milwaukee Journal Sentinel reported:

Employees at a Janesville nursing home risk losing their job if they do not take the COVID-19 vaccine, a policy that has caused outrage among many staff members.

Officials at Rock Haven, a Rock County-owned facility, issued a memo in December telling employees that the vaccine was “a requirement for all staff” and that employees who failed to get the vaccine would be laid off. A copy of the memo was obtained by the Milwaukee Journal Sentinel through an open records request.

According to the memo, a laid-off employee will not be eligible to return to work until they complete the two-dose vaccine regimen.

China Health Experts Call for Suspension of COVID Vaccines as Norway Investigates 33 Deaths, Germany Investigates 10 Deaths

The Defender reported:

Chinese health experts say Norway and other countries should suspend the use of mRNA vaccines like those produced by Pfizer and Moderna, especially among the elderly, according to Global Times.

Norway health officials confirmed last week they were investigating the deaths of 23 elderly people who died shortly after receiving the vaccine, and had confirmed 13 of those were directly related to the vaccine.

Today, Bloomberg reported that the number of deaths under investigation in Norway had risen to 33 and that all had occurred in people ranging from age 75 to 80. According to Bloomberg, Camilla Stoltenberg, head of the Norwegian Institute of Public Health, said at a press conference today:

“It is important to remember that about 45 people die every day in nursing homes in Norway, so it is not a given that this represents any excess mortality or that there is a causal connection.”

California Health Officials Call for Pause on Moderna Vaccine Batch Due to Reports of Allergic Reactions

The Defender reported:

California health officials are calling for a pause on the use of a huge batch of Moderna’s COVID vaccine due to its ”higher-than-usual number of possible allergic reactions.”

California’s top epidemiologist Dr. Erica S. Pan issued a statement Sunday evening recommending providers pause the administration of lot ‘041L20A’ of the Moderna COVID-19 vaccine due to possible allergic reactions that are under investigation.

“A higher-than-usual number of possible allergic reactions were reported with a specific lot of Moderna vaccine administered at one community vaccination clinic. Fewer than 10 individuals required medical attention over the span of 24 hours,” Dr. Pan said.

Biden to Deploy FEMA, National Guard to Set Up COVID Vaccine Clinics Across the U.S.

CNBC reported:

President-elect Joe Biden plans to use FEMA and the National Guard to build coronavirus vaccine clinics across the United States, according to new details of his Covid-19 vaccination plan released by his transition team on Friday.

The Biden administration will also “quickly jumpstart” efforts to make the vaccines available at local pharmacies across the U.S., which should ensure that Americans have access to doses at facilities not far from their homes, according to the plan.

Nursing Homes Make Big Push to Change Minds of Workers Who Refused Vaccination

NBC News reported:

Nursing homes across the country are facing the same struggle, as workers have been more reluctant than residents to be vaccinated. Though rates vary widely, the American Health Care Association, which represents for-profit nursing homes, estimates that about 50 percent of long-term care staff members have been hesitant to get vaccinated. The majority of direct-care workers in nursing homes are people of color, who have generally been more hesitant to get vaccinated, based in part on their distrust of the federal government and the United States’ history of medical racism.

Lyft and Uber Want to Take You to Your Vaccination Appointment

NBC News reported:

Operation Warp Speed has hit another speed bump: Now that the vaccines are rolling out, how are we supposed to get everyone to their vaccination appointments, twice?

For people with cars and child care options, the answer may be more simple. For others, it’s a scramble.

The ride-share companies Lyft and Uber, fielding requests from states and municipalities, are highlighting this gap in lobbying efforts aimed at President-elect Joe Biden’s incoming administration and offering “free rides.” But someone has to pay for them.

France, Once a Vaccine Pioneer, Is Top Skeptic in COVID-19 Pandemic

Wall Street Journal reported:

France’s mass vaccination campaign is off to a glacial start, with only around 422,000 people receiving the vaccine in more than three weeks since European regulators authorized the drug, far behind most other developed nations. A big reason: French officials are running up against deeply ingrained opposition that has made France among the world’s top vaccine skeptics.

An Ipsos poll conducted in December found that France ranked at the bottom of 15 countries on willingness to take a Covid-19 vaccine, with only 40% of the public saying they wanted the shot. Polls show that more than three-quarters of nursing home workers—who are among the government’s first target groups for the vaccine—don’t want to take it.

Thousands of COVID-19 Vaccines Wind Up in the Garbage Because of Fed, State Guidelines

NBC News reported:

Why is this happening? COVID-19 vaccines have a short shelf life once they are thawed out for use, Jha said. And because of federal and state mandates, hospitals and other health care providers would rather risk a dose going bad than give it to somebody who isn’t scheduled to get a shot.

At the same time, states like Massachusetts now have rules requiring hospitals to report the number of vaccine doses that have been discarded, Jha said.

“The problem is that hospitals that do report this get pilloried in the press for wasting vaccines,” Jha said. “So, many hospitals are not reporting and this is happening across the country.”

A black Market for Illegal Coronavirus Vaccines Is Thriving in the Philippines

Washington Post reported:

No coronavirus vaccine has been approved for general use in the Philippines, nor is one expected to arrive, officially, until at least February. It is illegal to import unauthorized pharmaceuticals. But soaring demand among Chinese workers, many of them employed in the Philippines’ lucrative online casinos catering to gamblers in China, is driving a black market in which vaccine doses are sold for many times the standard $30 price in China.

NIH Updates Its Position on Ivermectin

CovExit reported:

NIH concludes from its current analysis that, “results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide further guidance on the role of ivermectin in the treatment of COVID-19.”

The previous position of NIH, dated August 27, recommended against Ivermectin.

“The COVID-19 Treatment Guidelines Panel recommends against the use of ivermectin for the treatment of COVID-19, except in a clinical trial” stated then the NIH Panel, arguing that the “available clinical data on the use of ivermectin to treat COVID-19 are limited.”

***

January 15

Disneyland as a Vaccination Site? Airports as Test Centers? The Travel Industry Pitches In

New York Times reported:

Five months ago, San Francisco International Airport opened the first airport rapid coronavirus testing site in the United States. Nine months ago, some of the world’s most luxurious hotels, including Claridges in London and the Four Seasons in New York, began housing frontline doctors and nurses. And now another entity in the travel world is performing its own pandemic shift: Disneyland. This week the Anaheim, Calif., theme park began serving as a vaccination super site.

The coronavirus, which has killed more than 384,000 Americans and infected millions more, has brought the travel industry to its knees. The U.S. Travel Association, a trade group that promotes travel to and within the country, estimates that nearly 40 percent of all travel jobs have been eliminated since the virus took hold in March.

Willie Nelson Receives his COVID-19 Vaccine in Austin Area

WAA8 reported:

A famous Texan is proving that getting vaccinated is “Willie” cool.

Austinite Willie Nelson received the COVID-19 vaccine via drive-thru on Jan. 13. The shot was given to him at the Family Hospital Systems (FHS).

The country singer showed a proud “thumbs up” after receiving the shot. FHS shared photos of the vaccination on its Facebook page, encouraging others to get vaccinated.

Trader Joe’s, Instacart to offer employees incentives to get COVID-19 vaccines

Fox Business reported:

Beginning Feb. 1, Instacart will offer a $25 stipend for all eligible employees including shift leads, in-store shoppers and full-service shoppers.

The vaccine support stipend is “to ensure that, when the time comes, you don’t have to choose between earning income as an essential service provider or getting vaccinated,” the company said in its announcement.

Likewise, grocery chain Trader Joe’s, which has more than 50,000 employees, announced that it will give employees two hours of pay per dose for getting the vaccine. The Monrovia, California-based company said it will also shift around schedules to make sure employees have time to get vaccinated.

Their announcements came just 24 hours after Dollar General issued an incentive to encourage its team to receive the vaccine when it’s available to them.

First Pfizer COVID Vaccine Shot Cuts Risk of Infection by 50 Percent: Study

Newsweek reported:

A study published in the BMJ reviewing the results of a Phase III clinical trial, previously found that the vaccine may provide some early protection, but this only begins around 12 days after the first dose.

The BMJ study found that vaccine efficacy between the first and second doses was 52 percent when they were given 21 days apart.

The aforementioned estimates differ slightly from figures released by two of Israel’s four main health maintenance organizations (HMOs) on Tuesday, based on data from 400,000 patients in each area.

As Vaccine Eligibility Expands in U.S., So Does Confusion

New York Times reported:

The evolving distribution system for coronavirus vaccines in the United States has opened up the prospect of inoculations to millions more people this week, but has simultaneously set off a new wave of confusion.

At least 28 states and Washington, D.C., have begun vaccinating older people, a New York Times survey shows, in many cases marking a shift in earlier plans that put medical workers and nursing home residents at the front of the line for the inoculations.

EMA Warns Over Doctored COVID-19 Vaccine Data Hacked and Leaked Online

TechCrunch reported:

The European Medical Agency (EMA) has warned that information on COVID-19-related medicines and vaccines, which was stolen in a cyber attack last December and leaked online earlier this week, includes correspondence that’s been manipulated prior to publication “in a way which could undermine trust in vaccines”.

It’s not clear exactly how the information — which includes schematics of drug structures and correspondence relating to evaluation processes for COVID-19 vaccines — has been doctored.

One security researcher, Lukasz Olejnik, who has raised concerns about the leak via Twitter suggested the doctored data will be “perfect for sowing distrust” because the biotechnical language involved in the leaked correspondence will not be widely accessible.

India: Doctors Call for Investigation Into Allegations of Ethical Abuse in COVID-19 Vaccine Trial

The BMJ reported:

Multiple health groups in India have called for an investigation into allegations of ethical violations during a clinical trial of a COVID-19 vaccine developed jointly by India’s Bharat Biotech and the Indian Council of Medical Research.

In a statement released on 14 January, groups of doctors and health rights advocates asked the Indian government to halt the trial at the People’s Hospital in Bhopal, exclude any data from the site during trial analysis, and take action against those responsible for violations.

The Bharat Biotech vaccine is among two COVID-19 vaccines granted accelerated approval on 3 January by India’s drug regulatory authority for restricted emergency use, relying on safety and immunogenicity data without efficacy data.

Biden Picks Former FDA Chief to Lead Federal Vaccine Efforts

New York Times reported:

President-elect Joseph R. Biden Jr. has chosen Dr. David Kessler to help lead Operation Warp Speed, the program to accelerate development of Covid-19 vaccines and treatments, according to transition officials.

Dr. Kessler, a pediatrician and lawyer who headed the Food and Drug Administration during the presidencies of George Bush and Bill Clinton, has been a key adviser to Mr. Biden on Covid-19 policy and is co-chair of the transition team’s Covid-19 task force.

At Risk of Extinction, Black-Footed Ferrets Get Experimental COVID Vaccine

KHN reported:

In late summer, as researchers accelerated the first clinical trials of COVID-19 vaccines for humans, a group of scientists in Colorado worked to inoculate a far more fragile species.

About 120 black-footed ferrets, among the most endangered mammals in North America, were injected with an experimental COVID vaccine aimed at protecting the small, weasel-like creatures rescued from the brink of extinction four decades ago.The effort came months before U.S. Department of Agriculture officials began accepting applications from veterinary drugmakers for a commercial vaccine for minks, a close cousin of the ferrets. Farmed minks, raised for their valuable fur, have died by the tens of thousands in the U.S. and been culled by the millions in Europe after catching the COVID virus from infected humans.

***

January 14

Unexpected String of Allergic Reactions Causes Delays at ‘Vaccination Super Station’ Near Petco Park

NBC San Diego reported:

During the county’s weekly COVID-19 briefing, Dr. Eric McDonald, Director of Epidemiology for the county, said vaccinations were slowed down after allergic reactions were detected in six vaccine recipients.

While allergic reactions are expected in mass vaccination operations, that amount seen Wednesday was slightly higher than expected for that time period so the Super Station slowed down vaccinations so they could investigate, Dr. McDonald said. The site also swapped the vaccines it was using for a new batch out of an abundance of caution, in case the reactions had to do with the original batch.

A county spokesperson confirmed the vaccines associated with the allergic reactions were from Moderna, one of two pharmaceutical companies with FDA-approved COVID-19 vaccines.

Second Dose of COVID Vaccine Could Provide More ‘Intense’ Symptoms, Ezike Says

NBC Chicago reported:

Illinois’ top doctor said Tuesday that the second dose of the COVID-19 vaccine could provide recipients with more “intense” symptoms.

Illinois Department of Public Health Director Dr. Ngozi Ezike said that with the second dose of the coronavirus vaccine, some people have experienced “a more intense reaction.”

“People who said, ‘I didn’t feel anything on the first,’ some of them are saying, ‘Yeah, I felt some headache. I felt more pain,'” Ezike said. “So there is a more robust immune response that is manifest in that second dose.”

Johns Hopkins Scientist: ‘A Medical Certainty’ Pfizer Vaccine Caused Death of Florida Doctor

The Defender reported:

According to the New York Times:

“Dr. Jerry L. Spivak, an expert on blood disorders at Johns Hopkins University, who was not involved in Dr. Michael’s care, said that based on Ms. Neckelmann’s description, ‘I think it is a medical certainty that the vaccine was related.’

“‘This is going to be very rare,’ said Dr. Spivak, an emeritus professor of medicine. But he added, ‘It happened and it could happen again.’”

Spivak told the Times he based his reasoning on the fact that Michael’s disorder came on quickly after the shot, and “was so severe that it made his platelet count ‘rocket’ down.”

Spivak also offered two other reasons to back up his theory. One, the fact that Michael was healthier and younger than most people who develop chronic forms of ITP. And two, the fact that about 70% of people who develop ITP are women.

Coronavirus Cases Among Lawmakers Who Sheltered in Lockdown Show One Vaccine Dose May Not Immediately Protect Against Infection

Washington Post reported:

Three members of Congress may have contracted the coronavirus while sheltering in a crowded room as a pro-Trump mob stormed the Capitol, testing positive shortly after getting a first dose of the coronavirus vaccine.

Those positive tests do not mean the vaccines were faulty, experts said, noting that immune protection takes more than a week to kick in. Both the Pfizer and Moderna vaccines that are available to Americans require two doses for full protection; a single dose is not as effective as both.

“Early protection against COVID-19 may occur from about 12 days after dose one,” said Naor Bar-Zeev, an infectious diseases physician and epidemiologist at Johns Hopkins Bloomberg School of Public Health. People “should not really consider themselves protected really until after a week or two following dose two.”

Moderna Needs at Least 3,000 Adolescent Volunteers for Its COVID-19 Trial. They’re Struggling to Find Them

USA Today reported:

Not enough adolescents are signing up for Moderna’s COVID-19 vaccine trial, a federal official said this week, potentially delaying vaccine authorization for this age group.

Last month, the U.S. Food and Drug Administration OK’d use of the Pfizer-BioNTech vaccine for 16- to 17-year-olds, as well as adults. The companies did not have enough data in younger adolescents to apply for use in that age group, and Moderna had tested its vaccine only in adults, so it is authorized only for those 18 and up.

About four weeks ago, Moderna launched a trial in 12- to 17-year-olds, but apparently, the company is struggling to find enough adolescent volunteers.

Moncef Slaoui, the scientific head of Operation Warp Speed, the government’s vaccine effort, said Tuesday that while a vaccine trial in adults is accruing 800 volunteers per day, the teen trial is getting only about 800 per month.

CDC Says Vaccine Side-Effects ‘Tend to Be Mild’ in Response to Indiana Woman’s Claims in Viral Video

Courier Press reported:

Shawn Skelton, the Oakland City woman who went viral with Facebook claims that a COVID-19 vaccine caused her uncontrollable shaking and tongue spasms, is home from the hospital.

Saying she was discharged from Deaconess Orthopedic Neuroscience Hospital with body shaking that doesn’t stop and still no answers, Skelton said Tuesday she doesn’t know what lies ahead. She said an MRI, CT scan and blood cultures failed to produce anything.

“I have no hope so far,” she said. “I’m praying a lot.”

Doctors at the neuroscience hospital at Deaconess Gateway told Skelton her problem is likely stress-related, said her fiance, Rich Vidiella.

U.S. Vaccine Shift Stirs New Unease as 128 Million Join Line

Bloomberg reported:

In recommending that states start immunizing all residents 65 and older, along with all those between 16 and 64 with medical conditions that make them more vulnerable to serious disease, U.S. health officials are clearing a path for about 128 million more Americans to be vaccinated.

About 10 million people have received the first dose of a COVID vaccine since immunizations started in late December, according to Bloomberg’s vaccine tracker. The rapid shift in strategy has raised worries that an accelerated rollout, for which many states may not be ready, could lead to new shortfalls down the road.

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January 13

Dollar General Offers Workers Four Hours Pay to Get COVID-19 Vaccine

The Hill reported:

Dollar General announced on Wednesday that it is offering its workers four hours of pay if they go and get the COVID-19 vaccine.

The company said the offer is currently only applicable to frontline workers, but it plans to extend it to its distribution and transportation teams. The offer is only an incentive and the company will not require its workers to get the vaccine.

“We do not want our employees to have to choose between receiving a vaccine or coming to work, so we are working to remove barriers (e.g., travel time, mileage, child care needs, etc.) by providing frontline hourly team members with a one-time payment equivalent of four (4) hours of regular pay after receiving a completed COVID-19 vaccination and salaried team members with additional store labor hours to accommodate their time away from the store,” the announcement states.

Which U.S. Demographics Are More Likely to Refuse a COVID-19 Vaccine?

Medical News Today reported:

• A new survey indicates that over 31% of individuals queried had no intention of getting vaccinated against infection with SARS-CoV-2.
• According to the same source, the groups most likely to reject a COVID-19 vaccine are Black people, women, and those with conservative political leanings.
• The researchers who led the survey emphasize that policymakers must find better ways of communicating with and reassuring the public about the effectiveness and safety of COVID-19 vaccines.

Israel Expects to Start Vaccinating Children by March, Virus Chief Says

Reuters reported:

Israel may include children over the age of 12 in groups receiving COVID-19 vaccines within the next two months if research shows this is safe, a top health official said on Tuesday.

Vaccinating at a world-record pace, Israel says it aims to have administered one or both shots to 5 million of its 9 million citizens, and reopen the economy, by mid-March.

Operation Warp Speed Chief Resigns at Biden Team’s Request, Will Stay Through Transition, Sources Say

CNBC reported:

Slaoui was criticized when he took the job for his ties to the pharmaceutical industry; he resigned from the board of Moderna around the time his role was announced. He sold his shares in the company and said he donated their increase in value during the few days he held them while at the Operation Warp Speed helm.

He declined, though, to sell his shares in GlaxoSmithKline, where he spent 30 years and oversaw vaccine development, calling the stock his retirement.

Some Montana Schools Begin Preparing to Administer COVID Vaccines

3KRTV reported:

It’s not quite time yet, but some Montana school districts have begun planning to administer COVID-19 vaccinations to their teachers and staff when they are available.

According to the latest draft of the state’s COVID-19 Vaccination Plan, Frontline Essential Workers will receive the vaccine in Phase 1c. The Centers for Disease Control and Prevention says that group includes education workers such as teachers and support staff like bus drivers and school administrators. There are some cases where school district employees could fall into Phase 1b in Montana, including if they are over the age of 70 and/or if they have a qualifying, high-risk medical condition, which the state says includes cancer, COPD, heart conditions, and others.

Mayo Doctor Warns Against Mixing and Matching COVID-19 Vaccines

KARE11 reported:

According to updated U.K. guidelines, if the same vaccine is not available or if the first product received is unknown, it is reasonable to offer one dose of the locally available vaccine. But the guidelines also say every effort should be made to do two doses of the same vaccine. Mary Ramsay, head of immunizations at Public Health England, told Reuters mixing and matching was not recommended and would only happen on extremely rare occasions.

“I understand that thinking as a sort of desperation measure, but it’s not the same thing as evidence-based dosing,” said Dr. Greg Poland, professor of medicine and infectious diseases at Mayo Clinic and director of Mayo’s Vaccine Research Group.

Dr. Poland stressed this is why we have clinical trials.”The way we decide whether a vaccine is safe and effective is to subject it to clinical trials. Those clinical trials in the case of both the Moderna and the Pfizer vaccine suggested that we need two doses, and we need two doses a certain amount apart. Those trials only included two doses of the same vaccine. Once you depart from that, then we can no longer be confident about the safety, the efficacy or even the durability,” Dr. Poland said.

U.K. Delaying Second Dose of COVID Vaccines to 12 Weeks. Is That Even Safe?

Fortune reported:

The United Kingdom has veered into uncharted territory by changing tack and introducing a revised COVID-19 vaccination protocol, one that involves distributing the second dose at 12 weeks, rather than the prescribed 21 days.

It’s a move being watched the world over.

British health officials say that it’s the best way to apportion a limited number of doses and contain a deadly wave of contagion that has pushed the country into a series of extended lockdowns and has overwhelmed hospitals in the past month.

Why You Should Still Wear A Mask And Avoid Crowds After Getting The COVID-19 Vaccine

NPR reported:

Can I spread the virus to others even if I’m fully vaccinated?

This is an important question, but scientists studying the shots’ effectiveness don’t have an answer yet. And for public health experts, that lack of knowledge means you should act like the answer is yes.

Here’s why: Before approving the Moderna and Pfizer vaccines, the FDA asked the vaccine manufacturers only whether their products protect people from COVID-19 symptoms. They didn’t ask if the vaccines stop people who’ve been vaccinated from nevertheless spreading the virus to others. The emergency authorizations by the FDA that have allowed distribution of the two new vaccines cite only their ability to keep you — the person vaccinated — from becoming severely sick with COVID-19.

In the words of the Centers for Disease Control and Prevention, “Experts need to understand more about the protection that COVID-19 vaccines provide before deciding to change recommendations on steps everyone should take to slow the spread of the virus that causes COVID-19.”on vaccinated — from becoming severely sick with COVID-19.

JPM: ‘Very Soon,’ says Johnson & Johnson CEO as World Waits for Its COVID-19 Vaccine Data

FiercePharma reported:

Johnson & Johnson’s one-dose COVID-19 vaccine regimen could jump-start an immunization push that’s faltering in spite of the millions of doses Pfizer, BioNTech, AstraZeneca and Moderna are rolling out around the world.

And the J&J shot is on the verge of its next big step forward.

The pharma giant is in the “final stages” of data analysis for its phase 3 trial, CEO Alex Gorsky said Monday at the annual J.P. Morgan healthcare conference. The company hopes “to have that information very soon,” he added.

U.S. to Change COVID Vaccine Allocation to Favor States That Quickly Administer Shots

CNBC reported:

The federal government is changing the way it allocates coronavirus vaccine doses, now basing it on how quickly states can administer shots and the size of their elderly population, Health and Human Services Secretary Alex Azar said Tuesday.

States will be given two weeks to prepare for the change, Azar told reporters during a news briefing. That should give states enough time to improve their data reporting to the government and ensure all vaccinations are being “promptly” documented, he said.

States aren’t currently reporting vaccinations in a timely matter, Azar said, adding that vaccine doses “are sitting in freezers in hospitals.”

Bangladesh’s Beximco Could Start Private Sales of AstraZeneca Vaccine Next Month

Reuters reported:

Bangladesh’s Beximco Pharmaceuticals will buy up to 3 million doses of the AstraZeneca vaccine from Serum Institute of India at about $8 each for sale on the private market, Beximco’s chief operating officer told Reuters.

The COO, Rabbur Reza, said that was about twice the price of around $4 that Beximco had agreed for separate supplies of 5 million doses a month, over the first half of the year, for the Bangladeshi government’s subsidised mass-vaccination programme.

Serum Institute will begin deliveries of the shot later this month, both those for state and private use, Reza told Reuters on Tuesday. The vaccine is administered in two separate doses per patient, typically with weeks between them.

 

 

View archived entries January 12th – November 17th, 2020