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TGA Admits Minors Mistakenly Given AstraZeneca Vaccine and Says Woman’s Death an ‘Atypical Case’
More than a dozen teenagers as young as 14 have been given the AstraZeneca jab despite there being no vaccine approved for use in minors in Australia, as the Therapeutic Goods Administration confirmed the same jab was “likely” linked to the death of 48-year-old New South Wales woman Genene Norris.
The TGA has confirmed that as of 13 April they have received 13 reports of a teenager aged between 14 and 17 being vaccinated against medical advice.
A spokeswoman for the TGA said in most cases this was due to “an oversight in clinical practice, such as confirming patient age or prior vaccination.”
They have also received five reports of AstraZeneca vaccine dosing errors in adults.
Scientists Warn of ‘Vaccine Treadmill’ as Vaccine Makers Gear Up for COVID Booster Shots
Vaccine makers are telling investors and the media that COVID booster shots are already in the works. In some cases, companies say the boosters may be needed because the vaccine’s effectiveness may run out. In other instances, they suggest booster shots will be needed to combat new COVID variants.
Annual COVID booster shots are music to the ears of investors. But some independent scientistswarn that trying to outsmart the virus with booster shots designed to address the next variant could backfire, creating an endless wave of new variants, each more virulent and transmissible than the one before.
Pfizer CEO Albert Bourla said Thursday a third dose of the company’s COVID vaccine was “likely” to be needed within a year of the initial two-dose inoculation — followed by annual vaccinations.
FDA orders shutdown at Emergent’s troubled plant 2 weeks after handing J&J the keys
Two weeks after the U.S. stepped in and handed control of vaccine manufacturing at the plant to J&J, Emergent agreed to temporarily halt producing new drug substance there.
In March, the factory had to discard up to 15 million vaccine doses when it mixed up materials for the J&J and AstraZeneca vaccines. The New York Times reported an additional batch of between 10 million and 15 million doses of the AZ vaccine was lost last November because of suspected contamination at the plant.
The recent action comes after an FDA inspection last week. On Friday, at the FDA’s request, the company agreed to suspend manufacture of new drug substance and quarantine existing material manufactured there, “pending completion of the inspection and remediation of any resulting findings,” according to an 8-K filing.
As Blood Clot Concerns Mounted, J&J Reached Out to Rival COVID-19 Vaccine Makers to Form Alliance
Over the past year, rival drugmakers have worked in unusual solidarity to research and manufacture vaccines and therapeutics to combat COVID-19. But even crisis camaraderie has its limits.
Johnson & Johnson reached out to vaccine rivals — including AstraZeneca, Moderna and Pfizer — last week, hoping to join forces to study cases of rare and severe blood clots cropping up in some vaccinated people, The Wall Street Journal reported Friday, citing people familiar with the discussions.
The goal: to forge an alliance that would communicate the vaccines’ benefits and risks to allay fears among the public, the Journal reports.
The Blood-Clot Problem Is Multiplying
The Vaccine Safety Datalink, a collaboration between the CDC and nine large health-care organizations tracking data from anonymized medical records of millions of patients, was already watching for some clotting events, according to Ed Belongia, an investigator with the program and the director of the Center for Clinical Epidemiology and Population Health at Marshfield Clinic Research Institute, in Wisconsin. He told me the Vaccine Safety Datalink had not identified a risk from any of the three vaccines now authorized for emergency use in the U.S. The program is in the process of adding an alert for cerebral venous sinus thrombosis, the form of clotting that turned up in the six Americans who received the Johnson & Johnson vaccine.
The pandemic is still raging around the globe, and there is a real urgency to solve the riddle of the rare blood abnormalities linked to the AstraZeneca shot, and to figure out whether other vaccines carry the same risk. But recent history suggests that health officials might have to decide whether to restrict or resume vaccinations before scientists reach agreement. During the swine-flu pandemic of 2009, for example, a vaccine known as Pandemrix was given in Europe, and then some evidence emerged in Finland that it might be linked to narcolepsy. (The vaccine never became available in the U.S., and it’s no longer manufactured.) Although many scientists consider the narcolepsy risk well established, there is still no consensus on this point.
First Dose of Chinese COVID-19 Vaccine Offers Little Protection, Chile Learns
Several days after receiving his first dose of a Chinese-made coronavirus vaccine, Rodrigo Jordán fell ill and tested positive for COVID-19. The 61-year-old was hospitalized near his home in the Chilean capital, Santiago, for nine days and needed supplemental oxygen to pull through.
Across Chile — which has mounted one of the world’s most rapid vaccination campaigns using the vaccine made by Chinese drugmaker Sinovac Biotech Ltd. — health authorities are scrambling to deal with a surge in new infections and deaths.
More than 7.6 million people, half of Chile’s adult population, have already received at least one vaccine dose, most made by the Chinese drugmaker, making the country a real-world testing ground for a vaccine that Beijing is supplying to countries across the developing world.
The problem, public-health officials say, was that people in general overestimated the effectiveness of the vaccine after only one of the two recommended doses and moved to ease up on pandemic-control restrictions too soon.
‘We Were Flying Blind’: A Dr.’s Account of a Woman’s J&J Vaccine-Related Blood Clot Case
Researchers suspect that in these rare cases, the vaccine causes an intense reaction by the patient’s immune system, which churns out antibodies that activate platelets, a blood component needed for clotting. An unusual syndrome results, with extensive clotting that leaves the patient with low platelet levels and a tendency to bleed at the same time. Why this occurs in some people, many of them younger women, is not known, and experts say that they have so far been unable to identify traits or underlying conditions that may make some people susceptible.
In a statement issued on Wednesday, Johnson & Johnson said: “The safety and well-being of the people who use our products is our number one priority, and we strongly support awareness of the signs and symptoms of this extremely rare event to ensure the correct diagnosis, appropriate treatment and expedited reporting by health care professionals. We continue to believe in the positive benefit-risk profile of our vaccine.”
The company also said, in a letter published on Friday in The New England Journal of Medicine, that no causal link had been established between its vaccine and the clotting disorder.
COVID-19 Vaccine Demand is Slowing in Parts of the U.S. Now an Uphill Battle Starts to Get More Shots Into Arms
When health officials in Ohio’s Mercer County opened their first COVID-19 vaccine drive-thru clinic in January, available slots filled up instantly, and more than 500 people were vaccinated in a single day.
Nearly three months later, with plenty of vaccine supply on hand and eligibility open to all residents 16 and older, officials struggled to fill appointments, said Kristy Fryman, the emergency response coordinator and public information officer for the Mercer County Health District. About 264 people received their first dose at the district’s clinic earlier this month — roughly half the number of people who were signing up at the start of the rollout.
“It’s very concerning,” she said. The rural county is home to roughly 41,000 people and earlier in the pandemic had the highest COVID-19 case rate in the state, Fryman said. “We don’t want to go backwards,” she added.
Pfizer Backs Down Over ‘Unreasonable’ Terms in South Africa Vaccine Deal
Pfizer has backed down over its controversial demand that the South African government put up sovereign assets guaranteeing an indemnity against the cost of any future legal cases.
During COVID-19 vaccine negotiations, the company sought indemnity against civil claims from citizens who had experienced adverse vaccine effects – meaning that the government would have to cover the costs instead.
On Wednesday, the South African health minister, Zweli Mkhize, voiced frustrations about “difficult and sometimes unreasonable” terms his country’s government had been presented with during contract negotiations with vaccine manufacturers including Pfizer.
In a briefing letter sent ahead of his appearance at the parliamentary health committee, Mkhize said one condition in particular demanded by Pfizer was “too risky” – that the country put up sovereign assets as potential collateral.
J&J Scientists Refute ‘Class Effect’ to Blame for Clots in Those Who Got Its COVID-19 Vaccine
The blood clots in patients who received the J&J vaccine bear close resemblance to 169 cases in Europe reported with the AstraZeneca vaccine, out of 34 million doses administered there.
Both vaccines are based on a new technology that uses a modified version of adenoviruses, which cause the common cold, as vectors to ferry instructions to human cells.
The U.S. Food and Drug Administration is scrutinizing this design behind both vaccines to see if it is contributing to the risk.
In a letter on Friday in the New England Journal of Medicine, J&J scientists refuted a case report published earlier this week by Kate Lynn-Muir and colleagues at the University of Nebraska, who asserted that the rare blood clots “could be related to adenoviral vector vaccines.”
TGA Admits Minors Mistakenly Given AstraZeneca Vaccine and Says Woman’s Death an ‘Atypical Case’
More than a dozen teenagers as young as 14 have been given the AstraZeneca jab despite there being no vaccine approved for use in minors in Australia, as the Therapeutic Goods Administration confirmed the same jab was “likely” linked to the death of 48-year-old New South Wales woman Genene Norris.
The TGA has confirmed that as of 13 April they have received 13 reports of a teenager aged between 14 and 17 being vaccinated against medical advice.
A spokeswoman for the TGA said in most cases this was due to “an oversight in clinical practice, such as confirming patient age or prior vaccination.”
They have also received five reports of AstraZeneca vaccine dosing errors in adults.
National Cabinet Agrees to Fast-Track AstraZeneca Vaccinations for Over-50s
“The medical advice remains that the AstraZeneca COVID-19 vaccine is safe and recommended for Australians over 50 years old and all states will continue to be prioritised AstraZeneca for Australians over 50 years old.”
Earlier on Monday, Morrison hosed down hopes of a swift escalation of the vaccine program to allow the reopening of borders, while flagging the likely fast-tracking of the program for the over-50s.
He also suggested states could implement different quarantining regimes once international travel resumed, but warned it would be “many months” before borders would be relaxed, given the pandemic was “raging” overseas.
COVID Booster Shot Could Be Needed After 9 to 12 Months, White House Says
“We need to see what would be the sequence, and for how often we need to do that, that remains to be seen,” Bourla told a CNBC reporter during an event with CVS Health. The CEO’s comments were released on Thursday, but they were filmed two weeks ago.
Bourla added: “A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role.”
… “In order for us to even have the possibility of getting back to normal by the fall we need to massively scale up our genomic surveillance,” said Esther Krofah, who directs the Faster Cures initiative of the Milken Institute. “It’s the insurance program that you need to have in place not just now, not just for COVID, but going forward for other pathogens of concern.”
Scientists Warn Pfizer, Moderna Vaccines May Cause Blood Clots, Too
A study released today by Oxford University found the number of people who developed CVST blood clots after COVID vaccines was about the same for Pfizer, Moderna and AstraZeneca, MarketWatch reported. (J&J is not approved for use in the EU, where the study originated).
According to the study, 4 in 1 million people experienced CVST during the two weeks following vaccination with the Pfizer or Moderna vaccine, versus 5 in 1 million people for the AstraZeneca vaccine.
Although researchers found a significantly higher incidence of blood clots in people who were infected with COVID, the incidence of blood clots following vaccines was still much higher than the background incidence of 0.41, a strong signal that the vaccines pose this specific risk.
Latest VAERS Data Show Reports of Clotting Disorders From All Three Emergency Use Authorization Vaccines
Data released today by the Centers for Disease Control and Prevention (CDC) on the number of injuries and deaths reported to the Vaccine Adverse Event Reporting System (VAERS) following COVID vaccines revealed reports of blood clots and other related blood disorders associated with all three vaccines approved for Emergency Use Authorization in the U.S. — Pfizer, Moderna and Johnson & Johnson (J&J). So far, only the J&J vaccine has been paused because of blood clot concerns.
VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Every Friday, VAERS makes public all vaccine injury reports received through a specified date, usually about a week prior to the release date. Today’s data show that between Dec. 14, 2020 and April 8, a total of 68,347 total adverse events were reported to VAERS, including 2,602 deaths — an increase of 260 over the previous week — and 8,285 serious injuries, up 314 since last week.
Are Conversations About COVID Vaccines Fracturing Your Family? Here’s What You Need to Know.
Surveys conducted in March by Kaiser Family Foundation and Monmouth University show at least 20% to 25% of Americans remain resolutely uninterested in getting the shots — even in the face of family pressure.
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to three experimental vaccines — those developed by Pfizer-BioNTech, Moderna and Johnson & Johnson (J&J) through its subsidiary Janssen.
COVID Infection Rate is Approaching Highest Level Ever, WHO Chief Warns
“Around the world, cases and deaths are continuing to increase at worrying rates,” WHO Director-General Tedros Adhanom Ghebreyesus said in a briefing focused on Papua New Guinea and the western Pacific.
“Globally, the number of new cases per week has nearly doubled over the past two months. This is approaching the highest rate of infection that we have seen so far during the pandemic,” he continued.
“Some countries that had previously avoided widespread transmission are now seeing steep increases in infections,” Tedros said, citing Papua New Guinea as one example.
Malawi to Bin 16,000 AstraZeneca Doses Amid Fears of Rise in Vaccine Hesitancy
The vaccines are among 102,000 doses donated by the African Union (AU) to the Malawian government last month.
Health campaigners are concerned that the possible link with rare cases of blood clots and rumours that people were being given out-of-date doses of the vaccine were putting people off coming forward.
Norway’s Health Experts Recommend Banning AstraZeneca Jab As Nordics Get Cold Feet
While the EU touted its latest milestone in its vaccine rollout earlier this week, leading public health officials in Denmark decided to ban the AstraZeneca-Oxford COVID-19 jab over the risks of rare but sometimes fatal cerebral blood clots. And in the latest sign that the Nordic nations are fixing to block the AstraZeneca jabs, as leading public health experts in Norway officially recommended that their government implement a similar ban.
In a press release published Thursday, the agency announced that after examining the risks of the jab in concert with other government experts, they had determined that the continued use of the AstraZeneca jab – which, like the J&J jab, is based on the adenovirus platform – wouldn’t be appropriate.
COVID-19 Vaccines Are Entering Uncharted Immune Territory
The benefits of vaccination still far outweigh the risks: Experts told me they had no safety concerns about vaccinating people with weakened immune systems, who are often at higher risk of getting severe COVID-19. And in signing up for their shots, Rick and others like him can also help fill the data void that the clinical trials left, and potentially advance our understanding of how vaccines guard against the virus. Certain immunosuppressive drugs will undermine the vaccines in different ways; by pinpointing where, how, and in whom the shots most often falter, scientists might be able to discover which parts of the immune system are most essential for immunity against the coronavirus. “We still don’t understand why only certain people get so sick and die [from COVID-19],” Meena Bewtra, a clinical epidemiologist at the University of Pennsylvania who treats patients with inflammatory bowel disease, told me.
Australia Records First Fatality from Blood Clots Linked to AstraZeneca COVID Vaccine
Following a meeting of Australia’s Vaccine Safety Investigation Group on Friday, the Therapeutic Goods Administration said experts had concluded the case of the New South Wales woman, who died this week, “was consistent with causal association to immunisation.”
“In the absence of an alternative cause for the clinical syndrome, VSIG believed that a causative link to vaccination should be assumed at this time,” the TGA said in a statement.
CDC Reports 5,800 COVID Infections in Fully Vaccinated People
About 5,800 people who have been vaccinated against coronavirus have become infected anyway, the US Centers for Disease Control and Prevention tells CNN.
Some became seriously ill and 74 people died, the CDC said. It said 396 — 7% — of those who got infected after they were vaccinated required hospitalization.
It’s the first indication from CDC of how effective the vaccine is in real life — and the first indication the vaccines do not protect completely against severe disease and death.
Healthy 43-Year-Old Man Suffers Stroke From Blood Clot Hours After Receiving J&J Vaccine
A healthy 43-year old man in Mississippi suffered a stroke hours after being vaccinated with Johnson and Johnson’s (J&J) COVID vaccine. Brad Malagarie, father of seven, had received the vaccine a little after Noon and was found unresponsive by co-workers at his desk, WSAZ News Channel 3 reported.
“They called me and said he had that vaccine and something is wrong, we think it’s a stroke,” said Celeste Foster O’Keefe, Malagarie’s aunt and boss.
Malagarie was rushed to the hospital and diagnosed with a stroke after a blood clot had lodged in his left middle cerebral artery. O’Keefe said the family believes without a doubt that the vaccine caused the stroke.
“He’s a young, healthy 43-year-old, and I immediately thought it, and I said be sure to tell the doctors he took that J & J vaccine and that, to me, is what caused his stroke,” she told WSAZ.
O’Keefe said her nephew’s only health issue before the vaccine was high blood pressure, which was controlled with medication. One week after receiving the vaccine Malagarie remains hospitalized at Ochsner’s Medical Center in New Orleans and is in critical, but stable condition.
“He can’t talk now and he can’t walk. He’s paralyzed on the right side. He knows who we are and he will just cry when he sees us,” O’Keefe said.
18 Reasons I Won’t Be Getting a COVID Vaccine
A few friends have asked my thoughts on the COVID jab(s) so I thought it was time to write an article on the topic.
Knowing how contentious this issue is, part of me would rather just write about something else. But I believe the discussion/news is so one-sided that I should speak up.
As I always strive to do, I promise to do my best to be level-headed and non-hysterical.
I’m not here to pick a fight with anyone, just to walk you through some of what I’ve read, my lingering questions and explain why I can’t make sense of these COVID vaccines.
Stanford Begins Testing Pfizer Vaccine in Babies and Young Children
The littlest research volunteers arrived at Stanford University on Wednesday, accompanied by their parents, to participate in a pivotal study of the COVID-19 vaccine in very young children.
“We want our kids to be protected from the virus, and not to spread it to others if they do get infected,” said Zinaida Good of Palo Alto, whose 3-year-old son Andel sat still for a shot, then went home to play and take a nap. The family’s 7-month-old baby Soren is scheduled for a shot next month.
The goal of the trial at Stanford Health Care, the only site on the West Coast to test the Pfizer vaccine in children younger than five, is to identify the strongest dose with the fewest side effects.
As adult vaccinations expand, an increasing number of grownups can socialize, blissfully mask-free. About 75 million American adults are now fully vaccinated.
Johnson & Johnson ‘Pause’ Shakes Vaccinations Worldwide
After considering whether to reinstate the vaccine, a panel of expert advisers to the Centers for Disease Control and Prevention determined on Wednesday that it needed more time to assess a possible link to a rare but serious blood-clotting disorder.
In South Africa, health officials have stopped giving the Johnson & Johnson shot, two months after dropping another vaccine, from AstraZeneca. The European Union said it would not make any more purchases of the Johnson & Johnson vaccine or of AstraZeneca’s, which has raised similar concerns. If the perception takes hold that rich countries are dumping second-rate shots on poorer nations, suspicions about the efficacy of the vaccines could harden, slowing the worldwide rollout of desperately needed doses.
‘Young, Healthy’ South Mississippi Man Suffers Stroke Hours After Receiving J&J Vaccine
It started out as a normal day for 43-year-old Brad Malagarie of St. Martin. This busy father of seven spent the morning at his D’Iberville office before heading to get a Johnson & Johnson vaccine a little after noon.
He returned to work, and within three hours coworkers noticed he was unresponsive at his desk.
“They called me and said he had that vaccine and something is wrong, we think it’s a stroke,” said Celeste Foster O’Keefe, Malagarie’s aunt.
Dr. Anthony Fauci on What the Johnson & Johnson Vaccine Reactions Could Mean for Women
These are women of childbearing age. Does this suggest that it could be hormonal?
Absolutely and that’s one of the things that we wanna investigate. There have been similar types of phenomena that have occurred during pregnancy. Clotting abnormalities are known in women who take birth control pills, so certainly there could be a hormonal aspect to this.
Do you think birth control might play a role?
We don’t know that. And that’s one of the questions that’s gonna be asked about these people, was there a commonality of people on birth control pills? We don’t know the answer to that right now.
You pointed out this is less than one in a million chance that you may have this. It’s very, very rare. But will this fuel vaccine hesitancy?
Well, certainly that is a concern. The question that is often asked, does this have anything to do with the other vaccines, the mRNAs, from Moderna and from Pfizer? You know, absolutely not. Because you look at it, 121 million people have received at least one dose of a vaccine. Only 6.85 million of those were J&J. The rest were Moderna and Pfizer, and there’s no negative or adverse or red flag signal coming from any of those vaccines, which is very good news. In other words, they are very safe.
Moderna Hopes to Have COVID Booster Shot for Its Vaccine Ready by the Fall, CEO Says
Last month, the National Institutes of Health began testing a variety of offerings from Moderna to use as a third shot designed to boost immunity protection as concern grows about emerging variants — including the one first discovered in South Africa, also known as the B.1.351 variant.
The Food and Drug Administration’s approach to authorizing modified COVID vaccines is similar to that of annual flu vaccines, meaning they could be cleared for emergency use without lengthy clinical trials.
Norway Postpones Decision on AstraZeneca vaccine
Norway’s Institute of Public Health (FHI) recommended ending the use of the AstraZeneca vaccine, in line with a Danish decision announced on Wednesday, but the government needs more information before making a final call, the minister said.
Norway on March 11 suspended the rollout of the vaccine after a small number of younger inoculated people were hospitalised for a combination of blood clots, bleeding and a low count of platelets, some of whom later died.
‘Mix and Match’ UK COVID Vaccine Trial Expanded
Combining vaccines might give broader, longer-lasting immunity against the virus and new variants of it, and offer more flexibility to vaccine rollout.
Their second dose could be the same again, or a shot of Moderna or Novavax.
Chief investigator on the trial Prof Matthew Snape, from the Oxford Vaccine Group, said he hoped to recruit 1,050 volunteers who had already received one dose on the NHS in the past eight to 12 weeks.
Former World Leaders Urge Biden to Waive COVID Vaccine Patents
In an open letter shared by Oxfam on Wednesday, the signatories also urged Biden to support a proposal spearheaded by South Africa and India demanding the World Trade Organization (WTO) temporarily waive COVID-19 vaccine patents.
The measure would allow vaccine manufacturing to ramp up globally, the letter reads, as public health experts have raised concerns that low-income countries are behind left behind without access to critical coronavirus jabs.
At the current rate, the world’s poorest nations will have to wait until at least 2024 to reach “mass immunisation”, the signatories, which included former UK Prime Minister Gordon Brown, ex-French President François Hollande and Muhammad Yunus, winner of the Nobel Peace Prize, said.
World Struggles to Maintain Vaccination Drives Amid Mounting Reports of Side Effects
Governments around the world are scrambling to sustain already slow-moving vaccination drives amid troublesome news of very rare but severe side effects from two of the most prominent vaccines developed to fight the pandemic.
Multiple countries had already restricted use of the Oxford-AstraZeneca shot after European regulators flagged the vaccine as having potential links to extremely rare but potentially fatal blood clots.
Now that U.S. federal authorities have recommended pausing administration of the Johnson & Johnson vaccine due to similar clots, and while regulators investigate, governments in Australia, Europe and South Africa are also halting the shot’s rollout or scrapping plans to purchase more doses.
Johnson & Johnson Woes Continue, CDC to Announce Updated Recommendations Today
A 29-year-old woman told NBC News she was one of the six people who reported a case of a “rare and severe” type of blood clot after receiving the J&J vaccine. The woman said she got the vaccine March 19 and experienced a fever, trouble breathing and uncontrollable shaking. She was hospitalized for a week and placed in the intensive care unit.
“Since then, [I] have just had a few strange symptoms that could have been chalked up to a viral infection, mostly just a headache that persisted for two weeks, and some leg pain and swelling,” she told NBC News during a phone interview from her hospital bed.
Though the CDC is reviewing clinical data on six women who developed blood clots after receiving the J&J vaccine, VAERS shows 55 reports of blood coagulation disorders from the J&J vaccine through April 1 and 1,123 reports from all three vaccines combined, including Pfizer and Moderna through April 1.
Tucker Carlson: Either the Vaccines Work. Or They Don’t.
Carlson said the public was assured the vaccines are safe, that the risks were so small we could ignore them completely. In fact, we were told that the clinical trials revealed “no evidence at all” that the vaccines could cause any life-threatening injuries,” Carlson said.
But after Tuesday’s decision by federal health officials to shut down the Johnson & Johnson vaccine rollout — because six people experienced blood clots, including one who died — Carslon had a lot of questions.
‘This Week’ With Mary + Polly: ‘Not Even a Handful’ of Children Should Get This Vaccine
This week, Mary Holland, Children’s Health Defense president, and Polly Tommey, co-producer of “Vaxxed,” cover the latest on vaccine passports and how they’re more about getting everyone on the “digital platform” than about vaccines and public safety, attempts to weaken existing rules about research on human embryos, latest attacks on CHD and its chairman, Robert F. Kennedy, Jr. and what doctors in Israel think about COVID vaccines for kids … and much more.
Johnson & Johnson Vaccine: Local Family’s Sorrow Coincides With Pause Over Blood-Clot Worries
Aumann’s death is not counted among those six cases although her family alerted the CDC April 1 through the Vaccine Adverse Events Reporting System. One reason the government pauses the distribution of a drug is to learn whether others also have suffered the rare reaction.
The CDC system says 1,170 total deaths have been reported after inoculation with the Moderna vaccine, in use since January; 1,050 with the Pfizer-BioNTech vaccine, in use since December, and 54 with the J&J drug, in use since early March.
3 Different Futures for the Johnson & Johnson Vaccine
Based on what we know so far, the future of the J&J vaccine can fork in at least three different directions. In one, the vaccine flames out; unless many, many more cases come to light soon, this seems unlikely. Either of the other two — in which officials end the pause and return the nation to its regularly scheduled vaccine programming, with or without restrictions on who gets J&J next—are more likely. No matter the outcome, though, today’s announcement won’t quickly be forgotten. Pauses in clinical trials, sprinkled through the past year, have already stoked vaccine hesitancy, skepticism, and outright denialism in many circles. The Johnson & Johnson vaccine, previously stigmatized for being “less effective,” now risks a second label: “less safe.” It’s on the precipice of becoming our country’s grody vaccine; maybe it’s already toppled over the edge. An altered reputation in the U.S. will reverberate throughout the world, and set back the global struggle to contain the coronavirus.
The Challenges of Unravelling Long COVID
Another example of where we might be overstepping the evidence involves the COVID-19 vaccine. Soon after the rollout began expanding in the U.S., reports of long COVID patients feeling much better after their shot began to emerge. Some scientists have put forth possible theories for how this could be happening. If their symptoms were tied to lingering remnants of the virus, for instance, the boost in immunity might help the body clear these traces. Yet another plausible explanation hardly ever brought up is that many people, including those with long COVID, would understandably feel an overwhelming sense of relief from vaccination — relief that could alleviate, if only for a time, some of the symptoms they’re feeling. Interestingly enough, some long COVID sufferers have reported feeling worse following vaccination, while others haven’t felt any change. So there are really no clear indications of whether there is a true cause-and-effect link between vaccination and long COVID outcomes right now.
Vaccines Alone Will Not Stop COVID Spreading — Here’s Why
Australian virologist Ian Mackay, the first to use the Swiss cheese model in relation to the pandemic, says, in reality, the cheese’s holes will constantly open, shut and shift location depending on our behaviour.
This is why he and other scientists say, even in places with widespread vaccine coverage, we need to continue using multiple measures to stop the Swiss cheese’s holes aligning and letting the virus through.
U.S. Pauses Johnson & Johnson Vaccine, Citing ‘Rare’ Blood Clots
Federal agencies today said they will stop using the single-shot Johnson & Johnson (J&J) COVID vaccine at mass vaccination sites while they investigate the vaccine’s possible link to potentially dangerous blood clots. States and other providers also are expected to pause vaccinations.
In a joint statement from the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA), the agencies said they are investigating six cases of blood clots in the U.S. All six occurred in women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.
One woman died and a second woman in Nebraska was hospitalized and is in critical condition, The New York Times reported.
Rare Immune Response May Cause Blood Clots After AstraZeneca Vaccine, Researchers Say
Two teams of researchers have published detailed observations of patients who developed thrombotic thrombocytopenia after receiving the AstraZeneca vaccine and have speculated about a possible mechanism.
Both groups suggest that the development of serious blood clots alongside falling levels of platelets is an immune response that resembles a rare reaction to the drug heparin, called heparin induced thrombocytopenia. The researchers have labelled the syndrome vaccine induced immune thromboticthrombocytopenia.
Among more than 20 million people who have been vaccinated with the AstraZeneca vaccine in the UK so far, 79 cases of rare blood clots with low platelets have been reported, as well as 19 deaths. The European Medicines Agency and the UK’s Medicines and Healthcare Regulatory Agency have concluded that unusual blood clots with low blood platelets are a possible and rare side effect of the AstraZeneca vaccine but a causal relation has not been established.
Pfizer Vaccine May Put People at Higher Risk for COVID Variants, Israeli Study Shows
A new study by Israeli researchers found that a South African variant of COVID may put people who have been vaccinated with the Pfizer-BioNTech vaccine at higher risk of breakthrough infection compared to unvaccinated people.
The study also showed an increased incidence of the UK variant in those who received one dose of the Pfizer shot.
The study, released April 10, reviewed the positive COVID-19 test results of 800 people — 400 people who tested positive for COVID 14 days or more after they received one or two doses of the Pfizer vaccine against 400 unvaccinated people to see if those vaccinated were more likely to be infected with the UK or South African variant compared with unvaccinated individuals.
Why I Won’t Take the Johnson & Johnson Vaccine — a Scientist’s Perspective
Everyone is talking about DNA/RNA vaccines. Can they alter our own genetic codes?
The vaccine lobby says “Never!” I, however — laboring beneath the weight of a Ph.D. in virology — would instead quote Gilbert and Sullivan: “Well, hardly ever.”
Most people don’t know very much about DNA or RNA, so I’ll start with a 30-second chemistry discussion. DNA and RNA are both polymers, long strings (in this case, very long strings) composed of seemingly endless repetitions of a single basic chemical building block, called a nucleotide.
Children’s of Alabama Approved as New COVID-19 Vaccine Study Site for Young Children
Families who enroll their child or children in the study would help researchers figure out what doses are needed for young children to have COVID-19 protection. Pfizer recently completed research on children from 12-15 years old, and now vaccine companies are looking at what’s needed to give a vaccine safely to someone even younger.
“People have this misconception that children are not really sick or not many children get infected – which is true to a certain extent. But here at Children’s we’ve seen many people who get admitted to the hospital,” said Dr. Suresh Boppana, Professor Pediatrics at UAB.
Boppana has seen the impact of COVID-19 on young children and has worked to bring critical vaccine research to the hospital.
Amid COVID Surge, India Fast-Tracks Approval for Foreign Vaccines
India will fast-track emergency approvals for COVID-19 vaccines that have been authorised by Western countries and Japan, paving the way for possible imports of Pfizer-BioNTech, Johnson & Johnson, Novavax and Moderna shots.
The move, which will drop the need for companies to do small, local safety trials for their vaccines before seeking emergency approval, came following the world’s biggest surge in cases in the country this month.
Gilead to Stop Late-Stage Study of COVID-19 Treatment
Gilead Sciences Inc said on Monday it had decided to stop a late-stage trial of its intravenous treatment, Veklury, in high-risk non-hospitalized patients with COVID-19.
The company said it no longer believes that developing a multiple day injection that requires administration in a healthcare setting addresses an unmet need for non-hospitalized patients.
Researchers Studying ‘Breakthrough’ COVID-19 Cases of Infection After Vaccination
“We’ve seen some reports of what are called breakthrough infections where somebody has been fully immunized, and they still get infection,” he said. “What we suspect is that there may be a potential for someone who’s fully vaccinated to carry the virus to someone who hasn’t been vaccinated.”
Still, Flores said the vaccine protects against severe illness. Breakthrough cases give scientists a chance to understand what needs to be done to lengthen immunity and protect against variants.
“What we expect is that there’s probably going to be a need for a booster either annually or periodically,” he said.
People on the Caribbean Island Where a Volcano Went Off Are Being Evacuated on Cruise Ships — But Not Without a COVID-19 Vaccine
Cruise ships have been dispatched to the island that is being partially evacuated after the 4,000-foot high volcano La Soufrière erupted on Friday.
… But most of the islands would require vaccination before they take anybody in.
“If people are willing to welcome you at a time of COVID-19, they will wish you to have the highest level of protection possible,” Gonsalves told reporters on Saturday.
5 Reasons Johnson & Johnson Is Having a Very Bad Month
At the beginning of the month, the vaccine maker had to throw out 15 million doses of its vaccine after they were contaminated with AstraZeneca vaccine ingredients at an unapproved manufacturing plant. The setback contributed to last week’s announcement that the company won’t be able to deliver on its promise of 24 million additional doses of its one-shot vaccine by the end of April.
Those weren’t the only negative headlines. Last week, J&J vaccine sites in four states had to shut down after reports of adverse reactions. There also were multiple reports of COVID breakthrough cases in people who received the vaccine, marketed under its subsidiary, Janssen.
‘TRUTH’ With RFK, Jr. and Dr. Joseph Mercola: The Shadowy Alliance Between Big Pharma and Big Tech
In the latest episode of “TRUTH” with Robert F. Kennedy, Jr., Kennedy interviews Dr. Joseph Mercola on the fear-driven COVID-19 narrative, ongoing efforts to resist government restrictions and the loss of freedom seen around the world.
Nearly 40% of Marines Have Declined COVID-19 Vaccine
As of Thursday, approximately 75,500 Marines have received vaccines, including fully vaccinated and partially vaccinated service men and women. About 48,000 Marines have chosen not to receive vaccines, for a declination rate of 38.9%.
… The military cannot make the vaccines mandatory now because they have only emergency use authorizations from the Food and Drug Administration, meaning service members who are required to receive a series of other vaccinations have the option of declining shots to protect against COVID-19.
New York Sending COVID-19 Vaccines Directly to Colleges
Syracuse University Chancellor Kent Syverud told CNN over the weekend that the “vast majority” of faculty and staff members have already been vaccinated.
Over 4,000 SU students have already received shots as well, he added. The school has over 22,000 students total.
SU is making Covid vaccines mandatory for all students and staff.
EU Agency Examines Reports of Blood Clots with J&J COVID Vaccine
The EU’s drug regulator is reviewing reports of rare blood clots in four people who received Johnson & Johnson’s COVID-19 vaccine and has expanded its inquiry into AstraZeneca’s shot to include reports of a bleeding condition.
Of the four serious cases of clotting and low platelets, three occurred in the US during the rollout of J&J’s vaccine from its Janssen pharmaceuticals unit, the European Medicines Agency (EMA) said on Friday, adding that one person had died and one case was reported in a clinical trial. It was the first news of EMA’s inquiry into the J&J vaccine.
The EMA has already confirmed possible links between AstraZeneca’s coronavirus vaccine and very rare blood clots in the brain and abdomen.
More Colleges Say They’ll Require Students to Have COVID-19 Vaccines for Fall
… Current COVID-19 vaccines have been authorized by the Food and Drug Administration under an emergency use authorization, or EUA, which introduces a “new situation” for colleges, says Reiss. “We’ve never had the vaccine for the entire population authorized under EUA before.” So legal arguments have a little asterisk, she says, until vaccines are officially approved by the FDA, which could come as early as this summer.
“There almost certainly are going to be legal challenges because the anti-vaccine movement is already preparing for them,” says Reiss. “The main arguments will include the EUA question and the fact that these vaccines are early [in use].”
AstraZeneca’s Farxiga Fails Phase 3 COVID-19 Test
The DARE-19 trial showed that giving Farxiga (dapagliflozin) to COVID-19 patients at risk of developing severe complications wasn’t able to reduce the risk of organ dysfunction and death from any cause, or boost their chances of recovery.
The study was started a year ago at Saint Luke’s Mid America Heart Institute in the US, and was the first to test a drug in the SGLT2 inhibitor class for its potential in COVID-19.
The rationale for using the drug was that people with heart, kidney or metabolic conditions like diabetes are often more likely to develop severe disease and complications like organ failure.
Pfizer, BioNTech Seek U.S. Emergency Nod for COVID-19 Vaccine in Adolescents
The vaccine is currently authorized for emergency use in the United States for people aged 16 and up. The companies said on Friday that they requested an expansion of the authorization from the U.S. Food and Drug Administration to include the younger age group.
In March, the drugmakers said the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year olds in a clinical trial.
Study Bolsters the Case that Antibody Drugs Can Protect Against COVID-19
A monoclonal antibody cocktail developed by the drug maker Regeneron offered strong protection against COVID-19 when given to people living with someone infected with the coronavirus, according to clinical trial results announced on Monday. The drug, if authorized, could offer another line of defense against the disease for people who are not protected by vaccination.
The findings are the latest evidence that such lab-made drugs not only prevent the worst outcomes of the disease when given early enough, but also help prevent people from getting sick in the first place.
9-Year-Old Twins First Participants in Pfizer Vaccine Trial for Children
Pfizer’s vaccine trial in children under the age of 12 is already underway.
The first phase of the trials is to evaluate the safety of the vaccine in younger children and to determine what dose of vaccine should be given in the next larger phases of testing.
The initial study includes just 144 children who will all receive the actual vaccine. Nearly two weeks after getting the vaccine, 9-year-old twins Alejandra and Marisol Gerardo are doing well. They are the first participants in the trial for children under 12.
Latest VAERS Data Show Vaccine Injury Trends Continue, CDC Fails to Respond to The Defender’s Inquiries
Every Friday, VAERS makes public all vaccine injury reports received to the system for the previous week. Today’s data show that between Dec. 14, 2020 and April 1, a total of 56,869 total adverse events were reported to VAERS, including 2,342 deaths — an increase of 93 over the previous week — and 7,971 serious injuries, up 245 over the same time period.
More Johnson & Johnson Vaccine Clinics Hit Pause — 18 People Suffer Reactions at N.C. Site, 4 Hospitalized
The report followed Wednesday’s news that a J&J vaccine site in Colorado shut down after 11 people experienced reactions, and two were hospitalized.
According to a Wake County press release, more than 2,300 J&J vaccines were administered at the PNC Arena clinic in Raleigh. Eighteen patients suffered immediate adverse reactions and were evaluated by Wake County emergency medical personnel. Fourteen were treated on site and four people were transported to area hospitals.
‘No Medical Certainty’ Pfizer Vaccine Caused Death of 56-Year-Old Doctor, Medical Examiners Say
Dr. Gregory Michael developed the first signs of immune thrombocytopenic purpura (ITP), an autoimmune blood disorder which causes excessive bleeding, three days after receiving his first dose of the vaccine. He died Jan. 3 from a brain hemorrhage, after a team of doctors was unable to control his bleeding.
Medical examiners established that Michael died of complications from ITP, but officially categorized the death as natural because, according to Darren Caprara, director of operations for the Miami-Dade County Medical Examiner Department, there was “no medical certainty” the vaccine caused Michael’s death.
J&J COVID-19 Vaccine Deliveries to Drop Sharply Next Week
Deliveries of Johnson & Johnson’s COVID-19 vaccine doses throughout the U.S. are expected to plunge by more than 80% next week, according to state officials and federal data, as J&J grapples with manufacturing challenges.
The federal government has allocated just 700,000 doses of J&J’s vaccine to U.S. states, territories and certain cities and federal agencies next week, compared with 4.9 million doses that were allocated for this week, according to information posted online by the Centers for Disease Control and Prevention.
In Mississippi, 73,000 Vaccine Slots and Few Takers
In some ways, the growing glut of appointments in Mississippi is something to celebrate: It reflects the mounting supplies that have prompted states across the country to open up eligibility to anyone over 16.
But public health experts say the pileup of unclaimed appointments in Mississippi exposes something more worrisome: the large number of people who are reluctant to get inoculated.
“It’s time to do the heavy lifting needed to overcome the hesitancy we’re encountering,” said Dr. Obie McNair, an internal medicine practitioner in Jackson, the state capital, whose office has a plentiful supply of vaccines but not enough takers.
India’s Serum Institute Asks Government for $403 Million to Boost AstraZeneca Vaccine Output
The Serum Institute of India, the world’s biggest vaccine manufacturer, has asked the government for a grant of 30 billion rupees ($402.97 million) to increase its capacity to make AstraZeneca’s COVID-19 vaccine.
It is seeking the money to ramp up monthly production to more than 100 million doses by the end of May, the government said in a statement on Wednesday, noting output was currently around 65-70 million doses a month.
One Side Effect of the COVID-19 Vaccine Could Be a Heavier Period
There’s also a potential relationship between the nanoparticles used in the COVID-19 vaccines and changes in bleeding patterns. In some people, the nanoparticles end up creating a temporary immune reaction that kills off platelets, a type of blood cell involved in clotting, Clancy says. They regenerate quickly, but if someone has a bleeding event like a period just after they get a shot, it could make it heavier. She’ll be collaborating with Anirban Sen Gupta, a platelet researcher at Case Western Reserve University, to try to understand that potential mechanism.
Howard Dean Pushes Biden to Oppose Generic COVID-19 Vaccines for Developing Countries
Dean’s claim that global vaccine manufacturing is already at capacity is patently false. Foreign firms have lined up to offer pharmaceutical plants to produce vaccines but have been forced to enter into lengthy negotiations under terms set by the intellectual property owners. The waiver, however, would allow generic drug producers to begin copying the vaccine without delay.
Many of the manufacturing plants prepared to mass produce low-cost vaccines are centered in India, which has committed to supplying the poorest countries in the world. But the waiver petition, Dean wrote, “is unreasonable and disingenuous; it’s a ruse to benefit India’s own industry at the expense of patients everywhere. President Biden would be wise to reject it.”
Free Beer for COVID Vaccine: Samuel Adams Announces Incentive on National Beer Day and How to Get Free Coors Pure
The beer brand released a new national TV spot “Your Cousin From Boston Gets Vaccinated” Wednesday “to help combat skepticism amongst drinkers with humor” and announced the #ShotForSam vaccine incentive program.
A couple of caveats: The free beer for the COVID-19 vaccine offer starts April 12 – National Beer Day is held annually April 7 – and is for the first 10,000 drinkers who “share evidence of their vaccination on social media” by May 15 or while supplies last.
Henry Ford Health System to Run Clinical Trial of Moderna Vaccine for Children
The Henry Ford Health System will contribute to an ongoing national studying the efficacy of the Moderna COVID-19 vaccine in children, in a study similar to the one it conducted with adults last year.
Dr. Adnan Munkarah, Chief Clinical Officer, said that the hospital system will begin looking for parents to volunteer children between the ages of 6 months and 12 years old to take part in the study in the coming weeks.
The news came as staff at the Henry Ford Health System continued to deal with an onslaught of COVID-19 cases. Dr. Munkarah said more of the COVID patients being admitted are in their teens and twenties.
Obligatory Jabs ‘Necessary in Democratic Society’: Europe Rights Court
The European Court of Human Rights ruled on Thursday that obligatory vaccinations can be seen as necessary in democratic societies, in a landmark judgement after a complaint brought by Czech families over compulsory jabs for children.
This is the first time that the ECHR has delivered a judgement about compulsory vaccination against childhood diseases.
Experts say it could have implications for any policy of compulsory vaccinations against COVID-19.
Johnson & Johnson Vaccine Site Shut Down After 11 People Suffer Reactions, 2 Hospitalized
More than 600 people with appointments were turned away from a mass vaccination site in Commerce City, Colorado, after several vaccine recipients suffered adverse reactions to the Johnson & Johnson (J&J) one-shot COVID vaccine.
Centura Health, which helped run the community vaccination center at Dick’s Sporting Goods Park, said in a statement posted to Twitter that 11 patients who received the vaccine experienced adverse reactions. Two people were transferred to the hospital after medical staff determined they required additional observation. Centura officials did not specify what reactions were observed or their severity.
Could mRNA Vaccines Permanently Alter DNA? Recent Science Suggests They Might.
A March 10 press release pronouncing mRNA vaccines the clear winners of the COVID-19 vaccine race noted that all major pharmaceutical companies are now “testing out the [mRNA] technology by entering into license agreements and/or collaboration with well-established RNA companies.”
In old Disney cartoons, viewers often witnessed Donald Duck’s rich uncle, Scrooge McDuck’s, “bulging eyes [turn] into oversized Vegas slot machine dollar signs” when contemplating opportunities to increase his already immense wealth.
Judging by pharmaceutical company executives’ willingness to overlook mRNA vaccines’ long-term — and possibly multigenerational — risks, they must be similarly entranced by dollar-sign visions of a never-ending pipeline of “plug and play” mRNA products.
‘Perfectly Healthy’ Miami Doctor’s Death Two Weeks After Getting Pfizer Vaccine Ruled as Natural Causes Because Medical Examiner Cannot Find Any Medical Proof Jab was Responsible
A Miami doctor’s death two weeks after he received a Pfizer vaccine was due to natural causes, a medical examiner’s office has found.
Dr Gregory Michael, 56, died in January from a condition that can cause internal bleeding but experts found no link to the shot.
… However he died from a hemorrhagic stroke – when blood from an artery bleeds into the brain – before he could undergo the surgery.
… ‘My husband had conversations with the doctors who said it was highly probable that the vaccine was the cause.
‘It seems possible to me that somehow it instructed his body to attack the wrong thing, the platelets.’
One in 4 U.S. Adults Is Now Fully Vaccinated
The U.S. reached a milestone in its vaccination efforts on Wednesday, with new data showing that close to 25 percent of adults in the country have been fully vaccinated.
The data from the Centers for Disease Control and Prevention also show that 40 percent of adults and 75 percent of seniors have received at least one dose.
People Who Got the Moderna COVID-19 Vaccine Say They Have More Side Effects
Over 3,600,000 people who got their first dose of a COVID-19 vaccine before February 21st enrolled in v-safe and checked in at least once. Around 70 percent of those people said they had some kind of injection site reaction, like pain or swelling, and half had a more generalized reaction like fatigue or chills. For both, people who got a Moderna shot were more likely to have a side effect — 73 percent had an injection site reaction, compared with 65 percent of people who had a Pfizer / BioNTech dose. Around 51 percent of Moderna recipients had full-body symptoms, compared with 48 percent of people who got Pfizer / BioNTech.
COVAX Vaccines Reach More Than 100 Countries, Despite Supply Hits
The COVAX vaccine facility has delivered nearly 38.4 million doses of COVID-19 vaccines to more than 100 countries and economies across six continents as of Thursday, six weeks after it began to roll out supplies, a statement said.
The Big Hole in America’s Plan to Fight COVID-19 Variants
Finding vaccines that can ward off more contagious or virulent strains is only half the battle. The United States has virtually no capacity to manufacture revised vaccines or booster shots alongside the original versions, according to a half-dozen vaccine experts and Biden administration health officials. Setting up additional facilities could take months or even years.
Vaccine makers like Pfizer, Moderna and Johnson & Johnson coped with intense global demand for their original shots by manufacturing millions of doses while the vaccines were still in clinical trials. But that is not an option now, because the companies are still racing to fulfill orders for their existing COVID-19 vaccines — and some, including Johnson & Johnson and AstraZeneca, are struggling with major production setbacks. Pumping out second-generation shots would require factories to switch over manufacturing lines now used for the first wave of vaccines, and in some cases fire up new production processes.
With Virus Origins Still Obscure, WHO and Critics Look to Next Steps
The group is seeking a new inquiry that would include biosecurity and biosafety experts, one that could involve the W.H.O. or a separate multination effort to set up a different process to explore the beginnings of the pandemic and its origins in China.
Jamie Metzl, an author, senior fellow of the Atlantic Council, an international policy think tank and signer of the scientists’ letter, said the renewed calls for a more thorough investigation reflected the need for greater monitoring of and restrictions on what viruses can be studied in labs around the world.
The head of the W.H.O., Dr. Tedros Adhanom Ghebreyesus, said later that the mission’s consideration of a possible lab leak was not “extensive enough.”
NIH to Study Allergic Reactions to Pfizer and Moderna COVID-19 Vaccines
“A clinical trial is underway to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an immediate, systemic allergic reaction,” the NIH said in a statement.
“In addition, investigators will examine the biological mechanism behind the reactions and whether a genetic pattern or other factors can predict who is at most risk.”
A mast cell disorder is caused by a type of white blood cell that’s abnormal, overly active, or both. The disorder predisposes a person to life-threatening reactions that look like allergic reactions.
EU Regulators Find ‘Possible Link’ Between Blood Clots and AstraZeneca Vaccine, But Claim ‘Benefits Still Outweigh Risks’
The European Medicines Agency (EMA) did not recommend restricting use of the vaccine based on age, gender or other risk factors, but did say cases of blood clotting after vaccination “should be” listed as a possible side effect, according to a statement issued today by the agency’s safety committee.
Today’s recommendations followed the agency’s review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of March 22. Eighteen of the cases were fatal.“
A plausible explanation for these rare side events is an immune response to the vaccine similar to one seen in patients treated with heparin,” said EMA’s executive director, Emer Cooke, noting that the condition is called heparin-induced thrombocytopenia.
Senior Trump and Biden Officials Knew for Months About Problems at Vaccine Plant
Senior officials in the Trump and Biden administrations knew of oversight and quality assurance problems at Emergent BioSolutions’ Baltimore plant months before the company accidentally contaminated 15 million doses of Johnson & Johnson’s COVID-19 vaccine, according to two people with direct knowledge of the matter and an internal report.
Officials with the Trump administration’s vaccine program, Operation Warp Speed, and the Department of Health and Human Services were sent a report in June 2020 on Emergent’s inner workings. Written by a government official, the document concluded that the company’s plan for manufacturing urgently needed COVID-19 vaccines was inadequate. Emergent’s problems hiring and retaining skilled workers meant that it could not guarantee success in producing the shots, said the two people, who read the report and described it to POLITICO.
5 States Report Half Of New U.S. COVID Cases as Governors Demand More Jabs
As Texas watches COVID cases fall despite having scrapped all mandatory restrictions on businesses, masks and movement, a phenomenon that has befuddled Dr. Anthony Fauci, Johns Hopkins reports that roughly half of the new cases being reported in the US are coming from just 5 states, almost all of them controlled by Democrats: New York, Michigan, Florida, Pennsylvania and New Jersey.
Together, these states accounted for 44% of the nation’s new COVID infections, or nearly 197,500 new cases over 7 days. Total US infections during the same period was 452,000. In total, the US reported just under 63K total cases over the last 24 hours, while deaths retreated to just 353.
Drugs Targeting Immune Response To COVID-19 Show Promise
Researchers are reporting some progress in their search for drugs that tamp down the overwhelming immune reaction that can kill a patient with COVID-19.
These reactions are triggered by coronavirus infections, and can veer out of control in some people. It’s this reaction, rather than the virus itself, that is the real peril for people seriously ill with COVID-19.
Doctors last year recognized that a cheap and readily available steroid drug called dexamethasone can often rein in this overreaction, which is a form of inflammation. In fact, it’s the only COVID-19 drug so far that clearly saves lives.
… Gandhi says it’s important to remember that there are also drugs that can help keep people with COVID-19 out of the hospital in the first place. These are monoclonal antibodies that are customized to target and neutralize the coronavirus. They are available nationwide for people at elevated risk for hospitalization with COVID-19 and are available through a government program at no cost. But they are not used as widely as they could be.
Livingston’s Valneva Vaccine Shows ‘Strong Immune Response’
Biotech company Valneva tested its vaccine on 153 people and concluded it was safe and generally well tolerated.
The company will move to phase three by testing up to 5,000 people, some of whom will be recruited in Scotland.
UK Health Secretary Matt Hancock said if approved, the vaccine would play an “important role” in protecting communities.
Valneva, which manufactures its COVID vaccine at a plant in Livingston, said the results of their phase one/two study showed the vaccine was “highly immunogenic with more than 90% of all study participants developing significant levels of antibodies” to the COVID virus spike protein.
Cornell Mandates Students, Staff Get Vaccinated to Return to Campus
“With the recent announcements of expanded vaccine eligibility in New York and other states, and increasing vaccine production, it is likely that all members of our community will be able to obtain vaccination sometime this spring or summer,” the email reads.
“Accordingly, Cornell intends to require vaccination for students returning to Ithaca, Geneva, and Cornell Tech campuses for the fall semester.”
According to the New York Post, vaccine exceptions will be made for individuals with religious and medical exemptions.
Healthy Teen Diagnosed with Guillain-Barre Syndrome After Getting First COVID Vaccine
A Texas teenager diagnosed with Guillain-Barré syndrome (GBS) a few weeks after his first dose of the COVID-19 vaccine said he believes the vaccine is to blame, according to a local Houston news channel KPRC2 report.
“I wanted to get the vaccine,” said Wyatt McGlaun, a high school senior from The Woodlands. “I felt it was the right thing to do. I wanted to travel and enjoy my last summer before college.”
A few weeks after receiving the vaccine, McGlaun became weak and had difficulty walking. He was admitted to CHI St. Luke’s Health where he was diagnosed with GBS.
EMA Contradicts Senior Official’s Claim of ‘Clear Link’ Between AstraZeneca Vaccine and Blood Clots
A senior official from the European Medicines Agency (EMA) was quoted earlier today as saying there is a “clear” link between the Oxford-AstraZeneca COVID vaccine and a rare blood clotting syndrome — but hours later the EMA denied having already established a causal connection between the vaccine and blood clots.
In a statement to Agence France-Presse, the EMA said today it had “not yet reached a conclusion and the review is currently ongoing,” adding it expected to announce its findings on Wednesday or Thursday.
Marco Cavaleri, the EMA’s head of vaccines, had earlier told Italy’s Il Messaggero newspaper that in his opinion, “it is clear there is a link with the vaccine, but we still do not know what causes this reaction.”
246 Vaccinated Michigan Residents Diagnosed With COVID, 3 Dead, State Health Dept. Confirms
As many as 246 Michigan residents fully vaccinated against COVID-19 were later diagnosed with the virus, and three of them died, Michigan Department of Health and Human Services confirmed Monday. According to The Detroit News, 246 “breakthrough cases” were reported between Jan. 1 and March 31. All cases occurred in people who tested positive 14 or more days after the last dose in the vaccine series, said Lynn Sutfin, spokeswoman for the Michigan Department of Health and Human Services, in an email.
COVID-19: Italy Makes Vaccination Mandatory for Healthcare Workers
Italy has become the first country in Europe to make vaccination against COVID-19 mandatory for healthcare workers, as its government approved an emergency decree on 1 April to contain a third wave of the disease. Health professionals who refuse to have the vaccine will have the option to be transferred to duties that do not risk spreading the virus or to be suspended without pay for as much as a year.
U.S. Bet Big on COVID Vaccine Manufacturer Even as Problems Mounted
More than eight years ago, the federal government invested in an insurance policy against vaccine shortages during a pandemic. It paid Emergent BioSolutions, a Maryland biotech firm known for producing anthrax vaccines, to have a factory in Baltimore always at the ready.
When the coronavirus pandemic arrived, the factory became the main U.S. location for manufacturing COVID-19 vaccines developed by Johnson & Johnson and AstraZeneca, churning out about 150 million doses as of last week.
But so far not a single dose has been usable because regulators have not yet certified the factory to allow the vaccines to be distributed to the public. Last week, Emergent said it would destroy up to 15 million doses’ worth of the Johnson & Johnson vaccine after contamination with the AstraZeneca vaccine was discovered.
COVID-19 Vaccine Developed by U.S. Army Begins Human Testing
Army doctors plan to start testing on Tuesday the protein-based shot in as many as 72 adults ages 18 to 55 at the Walter Reed Army Institute of Research in Silver Spring, Md., the institute said. The team will test whether the vaccine safely induces the desired immune response in study subjects.
Initial results of the study could become available by midsummer. If the data are positive, the Army likely would try to join with a drug company to further test and develop the vaccine, said Kayvon Modjarrad, director of the institute’s emerging infectious-disease branch.
Moderna COVID-19 Vaccine Production Pace to Increase at Contract Manufacturer Catalent
Contract drug manufacturer Catalent Inc. is expanding its U.S. production of the COVID-19 vaccine from Moderna Inc., a development that could ensure the U.S. has ample supply as it ramps up vaccinations.
Catalent has reached an agreement with Moderna that will increase the speed of vaccine output at the contract manufacturer’s Bloomington, Ind., plant this month to about 400 vials a minute, according to people familiar with the matter.
Catalent will shift manufacturing of the shot to one faster production line from two slower ones. New doses will be ready for shipping starting next month, the people said, and the upgraded plant will be able fill an additional 80 million vials a year.
Vaccine Rollout to Exceed 100 Countries Soon, Covax Head Says
Countries like the U.S., the U.K. and Israel, and the developed world in general, have marched ahead with their vaccination programs since the first shots were approved in late 2020.
On the other end of the scale, more than 30 countries haven’t yet started or have barely commenced vaccinations, including much of Africa, according to the WHO.
“The big challenge here is the inequity that we talk about between developed countries and developing countries,” said Berkley, an epidemiologist.
Blood Clot Cases ‘Could Dent Faith of Young Women in AstraZeneca’
Health officials are becoming increasingly worried that younger people will reject COVID jabs as concerns about the AstraZeneca vaccine continue to grow. A total of 30 cases of rare blood clots have been linked to the jab in the UK, resulting in seven deaths. Eighteen million doses of the vaccine have been administered so far.
It is feared that younger women will be particularly anxious and may refuse to accept the vaccine because two-thirds of patients with these types of blood clots are female.
Scientists Challenge Health Officials on Vaccinating People Who Already Had COVID
To better understand immune memory of SARS-CoV-2, researchers led by Drs. Daniela Weiskopf, Alessandro Sette and Shane Crotty from the La Jolla Institute for Immunology analyzed immune cells and antibodies from nearly 200 people who had been exposed to COVID and recovered.
The results, published in Science, showed the immune systems of more than 95% of people who recovered from COVID had durable memories of the virus up to eight months after infection. Previous studies showed that natural infection induced a strong response, but this study showed that response lasted, Weiskoph said.Another study in Nature assessed the lasting immunogenic effect of T-cell reactivity to SARS and SARS-2. Data showed that natural immunity was very robust — and likely more robust than any immunity derived from a vaccine.
Epidemiologist: We Could Have Reached Natural Herd Immunity in 6 Weeks
Wittkowski considered “absurd” the idea of getting to 70-90% coverage with the vaccine, the stated target of some governments such as the U.S., UK and some EU countries.
“As early as a year ago in March (2020), Sunetra Gupta said we probably need to have about 50% of the population being immune because the basic reproduction number is somewhere around 2. However about 25% of people have cross-immunity from previous coronavirus infections. So we need only 25% of people to get infected or vaccinated.”
He goes on to say that when new infections dropped to zero or near zero in June, 2020 in New York, 25% of the New York population were already antibody positive.
“So a reasonable strategy would have been to test people who have antibodies and vaccinate those people who don’t have antibodies. And then we would have reached that point where people want to reach much earlier.
Moderna Shells Out for CEO Security as its COVID-19 Vaccine Grabs the Spotlight
“In response to the increased profile of our company and our executives as we pursued the development of a vaccine against COVID-19, in 2020 the company authorized the provision of personal and home security services to certain” executives, the proxy filing says.
Moderna’s profile has indisputably been elevated during the pandemic. The mRNA biotech had no authorized products and no sales at the start of 2020, and thanks to its success in developing an mRNA coronavirus shot, the company will never look the same again.
Researchers Are Hatching a Low-Cost Coronavirus Vaccine
A new vaccine for COVID-19 that is entering clinical trials in Brazil, Mexico, Thailand and Vietnam could change how the world fights the pandemic. The vaccine, called NVD-HXP-S, is the first in clinical trials to use a new molecular design that is widely expected to create more potent antibodies than the current generation of vaccines. And the new vaccine could be far easier to make.
Existing vaccines from companies like Pfizer and Johnson & Johnson must be produced in specialized factories using hard-to-acquire ingredients. In contrast, the new vaccine can be mass-produced in chicken eggs — the same eggs that produce billions of influenza vaccines every year in factories around the world.
U.S. Searches for New AstraZeneca Vaccine Producer After Emergent Mix-Up
The Biden administration already told Johnson & Johnson to directly take over vaccine manufacturing at Emergent’s Maryland plant after reports that the manufacturer had contaminated 15 million Johnson & Johnson doses with ingredients for AstraZeneca’s shot.
But now, officials are telling AstraZeneca to cut ties with Emergent entirely, worried about the prospect for more mishaps that could erode public confidence in COVID vaccines, the official said. They added that the administration has identified two potential partners for AstraZeneca to work with on future production.
Netherlands Pauses AstraZeneca Vaccine Rollout for People Under 60
The Netherlands has stopped administering the Oxford/AstraZeneca coronavirus vaccine to people under 60 following the death of a woman who had received one of the jabs, according to national news agency ANP.
Some 10,000 scheduled appointments for vaccinations will be scrapped as a result of the decision, the report said, citing the country’s health ministry as a source.
It comes days after the European Medicines Agency’s executive director said there was “no evidence” to support restricting the use of the medicine “in any population.”
Nationwide Children’s to Host COVID Vaccine Clinics for Teens in Central Ohio High Schools
If you’re a central Ohio teenager struggling to find a COVID-19 vaccine, you may not have to search much longer.
Starting Wednesday, Nationwide Children’s Hospital will host vaccine clinics in Franklin County high schools to help provide teens age 16, 17 and 18 with Pfizer-BioNTech vaccinations. Nobody younger than 16 can be vaccinated yet, though, because clinical trials for those age groups aren’t finished.
… Dr. Anthony Fauci, chief medical advisor to Biden, has said previously that he expects all teens to get vaccine access by fall. For children under 12, a “very likely” timeframe is early 2022, he said.
Pfizer Halts Corona Vaccine Shipments to Israel After Country Fails to Pay
Coronavirus commissioner Prof. Nachman Ash told the Post that if Israel does not speedily sign the necessary contracts that Israel may not be able to vaccinate its children or provide citizens with booster shots against vaccine-resistant variants, or if immunity wanes.
“There is real competition to buy vaccines by countries around the world,” Ash said in an interview last week. “We want to reserve our place at the top of the list and not be pushed down to the end so that we cannot get them [vaccines] when they are most needed.”
Expert Says Children Are Now Spreading COVID-19 Variant
A top epidemiologist is warning the B.1.1.7 variant of the coronavirus first identified in the United Kingdom may infect children more easily than previous strains.
“This B.1.1.7 variant is a brand new ballgame,” Michael Osterholm, director of the Center for Infectious Disease Research and Policy, said during an interview Sunday on NBC’s Meet the Press.
… Osterholm said in Minnesota nearly 750 schools reported cases of the more contagious variant over the last two weeks. The warning comes as kids all across the country have gone back into the classroom after months of learning from home.
Johnson & Johnson Has Begun Testing Its Vaccine in Adolescents Between 12 and 17 Years Old
The vaccine will now be tested in teenagers aged 16 and 17 first, and then expand to minors as young as 12.
Companies leading the Pfizer-BioNTech vaccine trials said earlier this week that their vaccine was highly effective in preventing COVID-19 infection in a late-stage trial for kids ages 12 to 15.
Number of COVID Vaccine Injuries Reported to VAERS Surpasses 50,000, CDC Data Show
Data released today by the Centers for Disease Control and Prevention (CDC) on the number of injuries and deaths reported to the Vaccine Adverse Event Reporting System (VAERS) following COVID vaccines revealed steadily rising numbers, but no new trends. VAERS is the primary mechanism for reporting adverse vaccine reactions in the U.S. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Every Friday, VAERS makes public all vaccine injury reports received to the system as of Friday of the previous week. Today’s data show that between Dec. 14, 2020, and March 26, a total of 50,861 total adverse events were reported to VAERS, including 2,249 deaths — an increase of 199 over the previous seven days — and 7,726 serious injuries, up 631 over the same time period.
Of the 2,249 deaths reported as of March 26, 28% occurred within 48 hours of vaccination, 19% occurred within 24 hours and 43% occurred in people who became ill within 48 hours of being vaccinated.
Alex Berenson: ‘I’m Not Going to Stop Asking Questions’
In the interview below on last night’s Tucker Carlson Tonight show, Berenson told the Fox News commentator that if you want to talk about the pros and cons of COVID vaccines — whether they’re working as hoped, how long immunity lasts, whether people are having severe side effects— “we can have a conversation about that.”
“But the public health establishment and the rest of the media don’t want to have these conversations,” Berenson said.
Instead, Berenson said, they’re “caught in a web of a story that doesn’t make sense,” where we’re told the vaccines are perfect, but you still have to wear masks and stay away from each other.
“When you pile the lies, the misstatements, the overstatements on top of each other, the story just doesn’t make sense,” Berenson said.
Australia Reviewing Blood Clot Case in Man Who Received AstraZeneca Vaccine
Pharmaceutical giant AstraZeneca faced new challenges to its coronavirus vaccine. Britain’s medicines regulator said Thursday that it found 30 cases of rare blood clots after the shot’s use, and Australia announced that it was investigating a possible link between the vaccine and clotting in a man who was recently immunized.
The European Union’s drug regulator and World Health Organization have both vouched for the safety of the vaccine, jointly produced by Oxford University and AstraZeneca, in recent weeks amid growing concerns that it may have caused perhaps dozens of rare blood clot disorders in Europe, out of tens of millions of doses administered.
Exclusive: Fauci Says U.S. May Not Need AstraZeneca COVID-19 Vaccine
Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said the United States has enough contracts with other vaccine makers to vaccinate its entire population, and possibly enough for booster shots in the fall.
Asked whether the United States will use the AstraZeneca vaccine doses, he said, “That’s still up in the air. My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccines to fulfill all of our needs without invoking AstraZeneca.”
Can Vaccinated People Spread the Virus? We Don’t Know, Scientists Say.
In a television interview with MSNBC’s Rachel Maddow, Dr. Walensky referred to data published by the C.D.C. showing that one dose of the Moderna or Pfizer-BioNTech vaccine was 80 percent effective at preventing infection, and two doses were 90 percent effective.
…Dr. Walensky went on to emphasize the importance of continuing to wear masks and maintain precautions, even for vaccinated people. Still, the brief comment was widely interpreted as saying that the vaccines offered complete protection against infection or transmission.
…“There cannot be any daylight between what the research shows — really impressive but incomplete protection — and how it is described,” said Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York.
“This opens the door to the skeptics who think the government is sugarcoating the science,” Dr. Bach said, “and completely undermines any remaining argument why people should keep wearing masks after being vaccinated.”
How the Novavax COVID-19 Vaccine Works
Novavax’s coronavirus vaccine, called NVX-CoV2373, differs from the three vaccines already being distributed in the United States. The vaccine relies on what is called recombinant nanoparticle technology and Novavax’s adjuvant, called Matrix-M, to stimulate an immune response and stimulate high levels of neutralizing antibodies.
When the genetic sequence for the coronavirus was published, Novavax scientists identified the gene for the spike protein and created a modified version of that gene. The researchers cloned the genes into a baculovirus that infects insects. They then infected moth cells — specifically, cells from the fall armyworm insect — with that virus, prompting them to produce the coronavirus spike protein.
These virus-like nanoparticles were harvested to make Novavax’s vaccine.
Parents Cheer News That Pfizer Vaccine Is Safe for Kids, but Not Everybody Is Convinced
Thirty-five percent of the 1,001 parents of public school students (kindergarten through 12th grade) who took part in a National Parents Union Survey in January said they wanted their children to be vaccinated immediately, while 25 percent checked “Yes, but not right away,” and 22 percent said they adamantly opposed vaccinating their children against COVID-19.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said children as young as first-graders might be able to get vaccinated by the start of the next school year in September. But a lot of American parents aren’t eager to get their children vaccinated — or themselves, for that matter.
“I feel like I would like to see some more studies on that,” Angelina Vicknair, a Louisiana mother of 6- and 9-year-old sons, said before the Pfizer announcement at a roundtable discussion about COVID-19 vaccinations for children sponsored by NBC affiliate WDSU of New Orleans. “I personally haven’t gotten the vaccine yet, so for me I’d rather wait.”
Pfizer, Biontech Say Trials Suggest COVID Vaccine Works Against South African Variant, Is Effective After 6 Months
Pfizer and BioNTech said Thursday that trials suggest that their vaccine is effective against a coronavirus variant that first emerged in South Africa, which some experts worry might evade existing shots.
The drugmakers also said in a statement that 12,000 people involved in their Phase 3 trial experienced high levels of protection against COVID-19 six months after their second doses, with no serious safety concerns.
“It is an important step to further confirm the strong efficacy and good safety data we have seen so far,” said Uğur Şahin, CEO and co-founder of BioNTech.
Short-Lived Romance: Pharma Industry Facing Heat for COVID Vaccine Failures, Greed
A Harris poll found that U.S. public opinion of the sector had risen to 62% in February, up from 32% before the pandemic, the biggest jump among several industries.
It could be a short-lived romance. “The impact on public opinion has been spectacular, but it’s not going to last,” Reinhard Angelmar, a health-care management specialist and emeritus marketing professor at INSEAD, says.
An unprecedented push to manufacture billions of doses this year alone has led to supply bottlenecks, putting firms such as Pfizer and AstraZeneca Plc in the firing line of angry government customers. The potential adverse effects of sticking needles into people’s arms are dominating headlines, as seen with the halting of the Astra vaccine in Canada and Europe even as regulators insist the benefits outweigh the risks.
Now the industry is taking heat for closely guarding its intellectual property. That’s blamed for what the World Health Organization dubs a “catastrophic moral failure”: the immunization gap between the developing world and deep-pocketed rich countries, which have ordered enough doses to cover their populations several times over.
This Florida university will require students to get the COVID-19 vaccine
Meanwhile, a private university in South Florida will require students and staff to be vaccinated for COVID-19 when they return to campus in the fall. Vaccinations are mandatory by Aug. 1, Nova Southeastern University said in an email announcing a Friday morning news conference.
“As the state, nation and world begins to emerge from the months-long changes to our lives brought on by the COVID-19 pandemic, Nova Southeastern University is pleased to announce that it intends to resume full, in-person classroom learning for on-ground courses for the fall 2021 semester,” the release said.
The university has 6,314 undergraduate students and 14,574 advanced degree students at its main campus in Davie, and across campuses in Fort Myers, Jacksonville, Miami, Miramar, Orlando, Palm Beach Gardens, Tampa and Puerto Rico.
Biden Administration Announces Ad Campaign to Combat Vaccine Hesitancy
Two hundred and seventy-five organizations will participate in the administration’s new public awareness push — including NASCAR, the Catholic Health Association of the United States and the North American Meat Institute — that is aimed at communities where vaccine hesitancy remains high. Among the organizations are many Catholic and evangelical groups that are expected to help address religious concerns about the Johnson & Johnson vaccine, which uses abortion-derived fetal cell lines.
The group is collectively called the COVID-19 Community Corps, administration officials said, and participating organizations are able to reach millions of Americans who trust those individual groups.
15 Million J&J COVID Vaccines Thrown Away After Ingredient Mix-Up With AstraZeneca
Fifteen million doses of Johnson & Johnson (J&J’s) vaccine failed quality control after workers at a Baltimore manufacturing plant negligently combined ingredients from AstraZeneca and J&J’s COVID vaccine.
The mix-up forced regulators to delay authorization of the plant’s production lines and prompted an investigation by the U.S. Food and Drug Administration (FDA).
First Cases of Post-Vaccine COVID-19 Confirmed in WA State. 2 Deaths Being Investigated
The first known cases of people developing COVID-19 after they were completely vaccinated were confirmed Tuesday in Washington, according to the state Department of Health. Two potential deaths are being investigated.
In vaccine parlance, people who develop a disease after they have been vaccinated for it are called “vaccine breakthrough” cases.
DOH said it is investigating the 102 breakthrough cases which have occurred in people at least two weeks after they were fully vaccinated. Eight people were sick enough to be hospitalized.
Sheriff Linked Vaccine to Death Despite Experts’ Cautions
A California sheriff announced in January that a man died hours after receiving a COVID-19 vaccine even though his county’s health officials said the declaration was premature and detrimental, The Sacramento Bee reported, citing emails obtained under the state Public Records Act.
…“Simply observing that somebody was vaccinated and then had something bad happen, hours or days later, doesn’t mean it was the vaccine that caused it,” said Dr. Arthur Reingold, head of the epidemiology division at the University of California, Berkeley.
The Place With Surprisingly High Vaccine Hesitancy
The problems plaguing Hong Kong’s vaccine efforts are unique, coming as they are at a time when Beijing is setting about on a program to comprehensively restructure the city’s institutions. But numerous other countries across Asia that did well in their initial efforts to suppress the pandemic are also stumbling in their vaccination programs. Along with Hong Kong, Japan and South Korea are struggling to get vaccines distributed at speed. In mainland China, where the virus originated and where officials have touted the superiority of homegrown vaccines and deployed them as a diplomatic tool, the rollout has also been rocky. The reasons in each country differ, but the delays threaten to put the region behind places such as the United States and Britain that were previously hit hard by the pandemic but have quickly vaccinated large swaths of the population, opening the possibility of economic rebound, freer travel, and a greater sense of normality.
‘More Confidence About the Results’: FDA Authorizes Two Rapid Coronavirus Tests for Home Screening
Consumers will soon be able to buy rapid coronavirus tests at chain pharmacies and grocers without a prescription after the Food and Drug Administration on Wednesday authorized two home tests.
The BinaxNOW coronavirus self-test will include two tests per kit for serial screening. The no-prescription test will deliver results in 15 minutes and does not require a lab. The FDA also authorized the Quidel QuickVue coronavirus test, which delivers results in 10 minutes and also can be used without a prescription.
The FDA has authorized more than 300 coronavirus tests and technologies in what’s becoming an increasingly crowded field of medical labs and tech firms touting different technologies.
Pfizer Warns EU Bureaucracy Is Holding Back Worldwide Vaccine Efforts
Danny Hendrikse, Pfizer’s vice president for global supply, said in a newspaper interview that it is “absolutely critical” its Belgium plant, which supplies 70 countries, has freedom of movement across borders.
Under new EU red tape, which Hendrikse says is putting pressure on the supply chain, Pfizer is required to alert the Belgian government ahead of time for every package of vaccines it intends to export. This in turn needs to be referred to the European Commission, the EU’s executive arm, for approval.
The Push to Vaccinate 20,000 Holocaust Survivors in New York
Despite having been eligible for vaccination since January, only 42% of New Yorkers 85 and older have been fully vaccinated, according to recent city data, which has jolted community groups into action. For Jewish organizations, the fact that this age group includes many Holocaust survivors — some of their community’s most vulnerable and treasured members — has created an all-hands-on-deck emergency.
Pfizer Says Its COVID Vaccine 100% Effective in 12- to 15-Year-Olds
In a study of 2,260 U.S. volunteers aged 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given placebo shots, Pfizer reported.
Pfizer said the study “demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.”
… Kids had side effects similar to young adults, the company said. The main ones are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
AstraZeneca Suspended Indefinitely in Germany for Anyone Under Age 60
Germany indefinitely suspended use of the Oxford-AstraZeneca COVID vaccine for anyone under 60 following advice from STIKO, the country’s independent vaccine committee and external experts. The committee investigated reports of blood clots, some fatal, in people who received the vaccine.
According to the Associated Press, Health Minister Jens Spahn and state officials unanimously agreed to give the vaccine only to people 60 or older unless they belong to a high-risk category where the benefits outweigh the risk of a serious side-effect.
“In sum, it’s about weighing the risk of a side effect that is statistically small, but needs to be taken seriously, and the risk of falling ill with corona,” Spahn told reporters in Berlin.
‘Breaking Through’ — States Report Growing Number of COVID Cases Among Fully Vaccinated
Washington isn’t the only state reporting breakthrough cases. Florida, South Carolina, Texas, New York, California and Minnesota have also reported cases of fully vaccinated people testing positive and becoming ill with COVID.
The Florida Department of Health in Volusia County had six documented breakthrough cases, Sumter County had six and Lake County had 26 cases, according to emails from each county spokespersons.
Dr. Sunil Joshi, president of the Duval County Medical Foundation, compared the COVID vaccine to the flu vaccine. “It’s like the flu shot, for instance, right. We know, we encourage people to get the flu vaccine. That doesn’t mean that you’re not going to get the flu. But the disease is significantly lessened,” Joshi said. “So remember, the whole goal for this, from the very beginning, has been to keep people out of the hospital. And so anything positive after the vaccine is not unusual, it can happen.”
Italy Pushes Back as Healthcare Workers Shun COVID Vaccines
In Italy, the original Western front in the war against COVID, a rash of outbreaks in hospitals where medical workers have chosen not to be inoculated has raised fears that their stance is endangering public health. It has also prompted a forceful response from an Italian government that is struggling to get vaccinations on track.
On Wednesday, Prime Minister Mario Draghi is expected to test the legal limits of his government’s ability to address the problem by issuing a decree requiring workers in health care facilities to be vaccinated. It will also allow hospital directors to suspend without pay any workers who refuse to do so, according to a justice ministry official who is familiar with the details of the measure.
Some legal analysts have said that requiring COVID-19 inoculation for health workers could violate Italy’s privacy laws, and that firing or forcing any who decline it to take unpaid leave could be unconstitutional because of a specific article that protects people who refuse health treatments.
Proper Informed Consent May Be Missing for COVID Vaccines, States Physicians for Civil Defense
In the rush to administer more than a million doses of COVID vaccines daily, proper consent is not being always documented, according to patients’ reports to Physicians for Civil Defense.
These products are not FDA approved, but are only available under an Emergency Use Authorization (EUA), notes Jane Orient, M.D., the organization’s president. By law, persons must be free to accept or decline such products.
The Fact Sheet for the Moderna COVID-19 product lists symptoms of a severe allergic reaction, and also states: “These may not be all the possible side effects of the Moderna COVID-19 Vaccine. Serious and unexpected side effects may occur. The Moderna COVID-19 Vaccine is still being studied in clinical trials.”
World Leaders, WHO Back Treaty to Prepare for Future Pandemics
As the world battles the biggest health crisis in recent history, leaders of 23 countries and the WHO have said an international treaty for pandemic preparedness will protect future generations.
The idea of such a treaty, aimed at tightening rules on sharing information and ensuring universal and equitable access to vaccines, as well as medicines and diagnostics for pandemics, was first floated late last year by European Council President Charles Michel.
On Tuesday, WHO Director-General Tedros Adhanom Ghebreyesus and several world leaders – including British Prime Minister Boris Johnson, German Chancellor Angela Merkel, French President Emmanuel Macron and his Rwandan counterpart Paul Kagame – threw their support behind the proposal.
“The world cannot afford to wait until the pandemic is over to start planning for the next one,” Tedros told reporters.
Pfizer to Test COVID-19 Vaccine That Doesn’t Need Ultracold Storage
Pfizer Inc. and partner BioNTech SE plan to begin soon testing a freeze-dried version of its COVID-19 vaccine, which if proven to work safely could ease storage and handling of the shots in rural U.S. areas and low-income countries.
In April, Pfizer is set to start a clinical trial evaluating a so-called lyophilized formulation in adults 18 to 55 years old in the U.S., according to a government database, clinicaltrials.gov and confirmed by the company.
The 1,100-subject study would last about two months, with researchers seeking to determine whether the lyophilized version is as safe and effective as the version authorized by regulators beginning late last year. Researchers would administer to subjects either the lyophilized version or the current formulation.
Pfizer Partner BioNTech, Riding High on COVID-19 Vaccine Launch, Eyes $11.5B in Revenue This Year
Pfizer and BioNTech have hustled to produce as many COVID-19 vaccine doses as possible this year, and that effort is paying off in a big way. After Pfizer unveiled a lofty COVID-19 vaccine revenue estimate last month, its partner BioNTech says it’s in line to collect more than $11 billion.
Under vaccine purchase orders the partners have already inked covering 1.4 billion doses, BioNTech stands to collect around €9.8 billion ($11.5 billion) in 2021, the company said Tuesday. In early February, Pfizer said it expected $15 billion in revenues from the COVID-19 vaccine this year.
Additional purchasing talks are underway, so the projections could increase as the year goes on.
BioNTech-Pfizer Raise 2021 Vaccine Output Goal to 2.5 Billion Doses
BioNTech cited its new facility in the German city of Marburg and an expansion of the pair’s network of third-party manufacturers and suppliers as drivers of the larger volumes.
“Additional measures and discussions with potential partners to further expand the manufacturing capacity and network are ongoing,” it said.
As of last week more than 200 million doses of the product, known as BNT162b2 or Comirnaty, had been supplied to more than 65 countries, while signed orders for delivery in 2021 currently amount to 1.4 billion doses, said BioNTech.
But the boost in output reflected increased demand and “discussions for additional dose commitments are ongoing”, it added.
All 50 States Now Have Expanded or Will Expand COVID Vaccine Eligibility to Everyone 16 and Up
All 50 states have announced when they plan to open up coronavirus vaccinations to everyone eligible under US Food and Drug Administration emergency use authorizations — if they haven’t done so already.
Arkansas is the latest state to announce plans to expand vaccine eligibility to anyone 16 and older, starting on Tuesday, Gov. Asa Hutchinson announced.
A dozen other states already also have expanded coronavirus vaccine eligibility to anyone 16 and older. And several states that previously announced plans to open up vaccine eligibility by early May have changed their timelines to open up in late March or early April.
Virginia Man Suffers ‘Rare’ Severe Reaction to COVID-19 Vaccine
“It all just happened so fast. My skin peeled off,” Terrell said as he looked down. “It’s still coming off on my hands now.”
“I began to feel a little discomfort in my armpit and then a few days later I began to get an itchy rash, and then after that I began to swell and my skin turned red,” Terrell explained.
Terrell said as days passed, things got worse. He had a consultation with a dermatologist and was told to go to the emergency room; on March 19 Terrell was admitted. The rash quickly spread over Terrell’s body. His legs and hands were almost unrecognizable from swelling and his skin was red and patchy.
Germany Hits Pause Again on AstraZeneca After 31 Reports of Rare Blood Clots, 9 Deaths
That same week, two independent research teams in Norway and Germany announced they had identified antibodies associated with the immune response that caused the type of blood clots experienced by some people who received AstraZeneca’s vaccine. As a result, France, Denmark, Norway, Sweden and Finland did not lift their restrictions on the vaccine’s use.
Finland and Sweden have since restricted the AstraZeneca vaccine to people 65 and older, while France resumed vaccination in people over 55. All three counties maintain the suspension for all other age groups, while Norway has delayed a decision on whether to resume using AstraZeneca’s vaccine for another three weeks.
Although AstraZeneca’s vaccine has been authorized for use in the EU, it has not yet received Emergency Use Authorization (EUA) in the U.S. The company plans to apply for EUA in the upcoming weeks. If approved, AstraZeneca would become the fourth available vaccine in the U.S., joining Moderna, Pfizer and Johnson & Johnson.
Canada Does About Face on AstraZeneca Vaccine, Citing Blood Clot Concerns
Canadian health officials on Monday suspended use of the Oxford-AstraZeneca COVID vaccine for people under age 55 following concerns the vaccine might be linked to rare blood clots, according to U.S. News & World Report.
“There is substantial uncertainty about the benefit of providing AstraZeneca COVID-19 vaccines to adults under 55 given the potential risks,” said Dr. Shelley Deeks, vice chair of the National Advisory Committee on Immunization.
According to ABC News, Deeks said the committee updated its recommendations amid new data from Europe suggesting the risk of blood clots is now potentially one in 100,000 — much higher than the one-in-1-million risk stated before.
Mutations Could Render Current COVID Vaccines Ineffective in a Year or Less, Epidemiologists Warn
Mutations of the coronavirus could render current vaccines ineffective within a year, according to a majority of epidemiologists, virologists and infectious disease specialists surveyed by the People’s Vaccine Alliance.
The survey of 77 experts from some of the world’s leading academic institutions across 28 countries found that almost a third gave a time frame of nine months or less. Fewer than 1 in 8 said they believed that mutations would never render the current vaccines ineffective.
Two-thirds thought that we had “a year or less before the virus mutates to the extent that the majority of first-generation vaccines are rendered ineffective and new or modified vaccines are required.”
Michigan Must Tell Johnson & Johnson Vaccine Recipients That It Was Developed Using Stem Cells
The language requiring the notification is contained in a state bill dealing with the allocation of funds from the $1.9tn economic relief package signed into law by Joe Biden earlier this month.
Each state legislature is responsible for allocating such funds. In Michigan, while Republicans and Democrats became embroiled in wrangles over moves that would have weakened the power of the Democratic governor, Gretchen Whitmer, which she ultimately vetoed, the “informed consent” provision slipped through almost unnoticed.
According to the Free Press, the bill states that anyone who receives a vaccine paid for through $110m appropriated in the relief legislation “shall be provided with information or informed if and in what manner the development of the vaccine utilized aborted fetal tissue or human embryonic stem cell derivation lines.”
How mRNA Technology Could Change the World
Synthetic mRNA, the ingenious technology behind the Pfizer-BioNTech and Moderna vaccines, might seem like a sudden breakthrough, or a new discovery. One year ago, almost nobody in the world knew what an mRNA vaccine was, for the good reason that no country in the world had ever approved one. Months later, the same technology powered the two fastest vaccine trials in the history of science.
Like so many breakthroughs, this apparent overnight success was many decades in the making. More than 40 years had passed between the 1970s, when a Hungarian scientist pioneered early mRNA research, and the day the first authorized mRNA vaccine was administered in the United States, on December 14, 2020. In the interim, the idea’s long road to viability nearly destroyed several careers and almost bankrupted several companies.
COVID: Past Infection Increases Vaccine Response Six-Fold
The researchers pitted cells from participants’ blood against different variants of the virus in the lab.
Vaccinated healthcare workers were less able to fight off variants, particularly the South African strain, than the original strain the vaccine is based on.
But this effect was less in people with infection-acquired immunity plus a single dose of the vaccine.
This implies a second booster dose could work in the same way, providing better protection against the virus as it mutates – although this is yet to be proven.
How Long Will the Coronavirus Vaccines Protect You? Experts Weigh In
In fact, much of this hypothesizing comes from extrapolating data examining immune responses in people who have had COVID-19 and illnesses from other coronaviruses, rather than in people who have been vaccinated, said Dbeibo, who is director of vaccine initiatives for Indiana University.
“But vaccine responses should not be less reliable than in natural infection,” she added.
Current research shows that people who have been infected with COVID-19, the illness caused by the coronavirus, retained immunity that was robust after eight months. That gives researchers a starting point in predicting how long immunity may last after vaccination, Dbeibo explained.
Stanford Scientists Reverse Engineer Moderna Vaccine, Post Code on Github
The scientists requested permission from the FDA to keep emptied vials that were going to be discarded at Stanford and Veteran’s Affairs vaccination sites. “Given the ability of Next Generation Sequencing technology to detect even minuscule amounts of RNA, this was more than sufficient to assemble a coding region for the two vaccine RNAs,” they said.
The scientists told Motherboard they felt that their peers working at Moderna/NIH and BioNTech/Pfizer had done the world a great service and that releasing the RNA sequences will help continue to benefit humanity. “While anyone interested could data-mine and filter these sequences out later, there is a substantial economy of scale and educational value in having the sequences available ASAP and in not having to guess where they have come from,” they said.
This isn’t the first time a COVID-19 vaccine has been reverse-engineered and shared online. On December 25, 2020, PowerDNS founder Bert Hubert used publicly available information about the BioNTech/Pfizer vaccine to figure out its mRNA sequence.
AstraZeneca Vaccine Renamed ‘Vaxzevria’
The coronavirus vaccine produced by the AstraZeneca pharmaceutical company is now called Vaxzevria, the Swedish medicine agency Läkemedelsverket announced based on data from the European Medicines Agency.
The vaccine itself remains unchanged, but the Swedish agency considers the new name important, as it is accompanied by other things, such as new labelling and packaging.
The name change to Vaxzevria was approved by the EMA on 25 March, following an application from the company.
Krispy Kreme Faces Backlash for Free Doughnut Promotion for Vaccinated People
“Every single person who goes out and gets that vaccine brings us that much closer to a post-COVID America, which we’re really excited about,” Dave Skena, chief marketing officer and global director of brand at Krispy Kreme, told NBC’s Kristen Dahlgren on Weekend TODAY. “And so, if we can show our support with a little tasty treat, then that’s what we want to do.”
But not everyone was sweet on the giveaway idea, with some calling it discrimination against those who don’t want the vaccine. One Twitter commenter wrote that Krispy Kreme was part of the “indoctrination of American citizens.”
“I can’t believe people actually fall for this propaganda,” another tweeted. “…amazing how many weak-minded gullible ignorant people are walking around this planet right now… throw your life away…reprogram your DNA .. all for a card showing you cooperated.. and a donut.”
WHO Says ‘Extremely Unlikely’ COVID Escaped From Lab, But Scientists Call for Deeper Investigation
According to a draft copy of the WHO-China report obtained by AP, investigators said it is “extremely unlikely” the virus leaked from a lab.
However, two people interviewed Sunday night on 60 Minutes said the WHO investigation was incomplete and the lab theory cannot be ruled out.
Jamie Metzl, former National Security Council official in the Clinton administration and member of a WHO advisory committee on genetic engineering, blamed the Chinese government for failing to cooperate with the WHO investigative team.
Metzl told 60 Minutes that even though there have been accidental lab leaks of viruses in China in the past that have infected people and killed at least one, “no one on the WHO team was trained in how to formally investigate a lab leak.”
Metzl is part of an international group that, on March 4, released an open letter calling for a full and unrestricted international forensic investigation into the origins of the pandemic. He told 60 Minutes that the lab leak theory is plausible and deserves a full investigation. He said that the Wuhan Institute of Virology’s (WIV) own lab reports show that it sent field researchers to the bat caves and that they brought back samples with coronaviruses:
“ … we do know that there were nine viruses at least that were brought back. And it’s extremely possible that among these viruses is a virus that’s much more closely related to the SARS-CoV-2 virus. And when I put all those pieces together, I said, ‘Hey, wait a second, this is a real possibility. We need to be exploring it.’”
WaPo Columnist Slams NY Times for Dismissing Ex-CDC Director’s Theory Coronavirus Came from Wuhan Lab
A Washington Post columnist slammed The New York Times for “bending over backwards” to dismiss the theory that coronavirus escaped from a lab in Wuhan, China, tweeting that the rival liberal paper is “the opposite of objective.”
The Times published an article on Friday that seemed to initially call the theory “debunked,” but then declared it’s simply “extremely unlikely” and the word “debunked” vanished from the story.
“They are bending over backwards to defend one theory over another. It’s the opposite of objective,” Washington Post columnist Josh Rogin wrote.
Washington Examiner reporter Jerry Dunleavy pointed out the headline that appears when the article is found on Google was, “Ex-CDC Director Favors Debunked COVID-19 Origin Theory.” As of Monday morning, a Google search of the article still reveals the word “debunked” in the headline despite a different headline appearing once the article is clicked on.
“The lab-leak hypothesis has not been debunked,” Dunleavy wrote.
The Times apparently updated headline, “The CDC’s ex-director offers no evidence in favoring speculation that the coronavirus originated in a lab,” appears without an editor’s note or correction.
Scientists Seek COVID Treatment Answers in Cheap, Older Drugs
As a result, efforts to repurpose drugs have fallen to philanthropists, some in the Bay Area. “We’re missing out on public health benefits of the drugs we already have because we’re relying almost entirely on capitalism and private industry to make advances,” said Elaine Lissner, founder of the San Francisco-based Parsemus Foundation, which is supporting COVID research on fluvoxamine and other low-cost oral drugs.
Repurposing is a long shot, yet compared to creating drugs and vaccines, the approach has clear advantages during a fast-moving pandemic. “If it works and it’s on the shelf, you don’t have any development time,” said Dr. Lisa Danzig, a specialist in infectious diseases who consults with companies, investors, government and philanthropies. One of the best treatments in the COVID arsenal — the common steroid dexamethasone — is a repurposed drug. But it is recommended only for hospitalized patients who are seriously ill.
Danzig was “very excited” last April by news that a team led by University of California-San Francisco researchers had identified 69 possible drugs that, when used early on, could counteract infections with SARS-CoV-2, the virus that causes COVID. “I’m thinking, if we can rapidly test some of these in clinical trials, we can have answers by October.”
RFK, Jr. to Rutgers President: COVID Vaccine Mandate Violates Federal Law
The reason for the right of refusal stems from the fact that EUA products are by definition experimental, Kennedy wrote. “Under the Nuremberg Code, no one may be coerced to participate in a medical experiment. Consent of the individual is ‘absolutely essential,’” Kennedy wrote.
Kennedy said forced participation in a medical experiment could result in injury.
Dr. Hooman Noorchashm, who also spoke out against Rutgers’ policy, agreed. Specifically, he said, students should be pre-screened for COVID infection before vaccination.
In an open letter to Rutgers, Noorchashm, a surgeon and patient safety advocate, wrote:
“While I fully agree with your policy of maximal immunity for all students and faculty attending in-person on the Rutgers campuses, you must also remain 100% cognizant of a potential danger of indiscriminate vaccination to some of your students. This potential danger is not only a safety risk, it would also pose a risk of liability to your university.”
‘All Hands on Deck’: When Vaccinating Black People Is a Communal Effort
After months of agitation by local elected officials, the state health authorities recently announced that they would use the National Guard to stage a mass vaccination event at a park in Livingston. For Drucilla Russ-Jackson, 72, an African-American district leader in Sumter County, it was a vindication of her efforts to prod the state into action. Armed with a stack of fliers, she spent much of last week navigating the county’s rutted back roads to reach constituents spread across the cotton fields and the pine forests.
At the M&M Market, one of the few gas stations in the area, she strong-armed customers like James Cunningham, 71, a retired truck driver who doesn’t own a cellphone or a computer, and who lives with his 87-year-old mother.
“To be honest, I didn’t even know where to begin,” he said of his reaction after Ms. Russ-Jackson told him about the one-day vaccination juggernaut, which was scheduled for the following Tuesday, on March 23.
The event, it turns out, illustrates the difficulty of the mission. At the end of the day, more than half of the 1,100 doses were left unused. Ms. Russ-Jackson said turnout might have been dampened by the rain. Or perhaps it was the resistance of older residents, scarred by the government-run Tuskegee syphilis experiments in eastern Alabama.
Fauci Says it’s ‘Conceivable’ to Send Unvaccinated Children to Summer Camps, Playgrounds
“If we get into the summer and you have a considerable percentage of the population vaccinated and the level in the community gets below that plateau that’s worrying me and my colleagues in public health, it is conceivable that you would have a good degree of flexibility during the summer, even with the children, with things like camps,” Fauci said. “We don’t know that for sure, but I think that’s an aspirational goal that we should go for.”
Fauci has previously said elementary-aged children will likely not get vaccinated until early 2022.
Fauci stressed that children can still get infected and should continue wearing masks when interacting with groups from multiple households.
“If the adults are vaccinated and you’re in the home with your child, you don’t need to wear a mask and you can have physical contact,” Fauci said.
White House Weighs Temporarily Lifting Intellectual Property Shield on COVID-19 Vaccines
The move would allow other countries to replicate existing vaccines. The United States has so far approved three vaccine shots: one developed by American company Pfizer and German-based BioNTech, another produced by U.S. firm Moderna and the third made by American company Johnson & Johnson.
Concerns have grown about the U.S. and a handful of other wealthy countries owning the rights to a disproportionate amount of the global vaccine supply, while other nations struggle to inoculate their people.
The Hill first reported the support for the move from progressive lawmakers.
The Office of the U.S. Trade Representative, which would be expected to deliver a final verdict to the World Trade Organization, said saving lives and ending the pandemic remains the “top priority of the United States.”
We Can’t End the Pandemic Without Vaccinating Kids
Children are the next vaccination frontier. When it comes time to vaccinate them, the same urgency and large-scale coordination efforts driving adult vaccination must continue if we want to sustainably drive down COVID-19 cases and ultimately end the pandemic.
Currently, vaccine demand among adults exceeds the supply. But there’s reason to worry that once children are eligible, vaccination rates for them will initially be far lower and rise more slowly than those seen among adults. Children are much less likely than adults to be hospitalized with COVID-19, and deaths from the disease among kids are rare. Parents may wonder, if COVID-19 is relatively harmless for my children, what’s the hurry?
One reason to vaccinate children quickly is that even a small number of critical COVID-19 cases among children is worth vaccinating against. The burden of long-term effects from COVID-19 in children — including rare but serious cases of inflammatory syndrome — remains unclear, especially since many have asymptomatic infections that go undiagnosed.
NFL Won’t Require Players, Coaches to Get COVID-19 Vaccine
“The NFL and the NFL Players’ Association have no intention of making the COVID-19 vaccine mandatory for players, coaches or staff,” Sills said. “What we are focusing on is education. We want everyone to have the facts, and we believe that this is an important step forward.”
Sills mentioned the 2021 draft in late April as a league event in which teams hosting events involving only fully vaccinated people would have fewer restrictions than those that include unvaccinated people. He also said that while the league will have no requirements to get vaccinated, the hope is that everybody will.
“We’ll continue those discussions and go where the science leads us on that, but I think we’ve got a lot to learn between now and then. But we’re really going to focus on getting that education and continuing that dialogue,” Sills said. “We’re seeing a lot of dialogue between players, coaches and staff about vaccination. We hope that everyone gets vaccinated.”
68-Year-Old Dies After Anaphylactic Reaction to COVID Vaccine as CDC Continues to Ignore Inquiry Into Increasing Number of Deaths
This week’s VAERS data included 2,306 reports of anaphylaxis. Fifty-five percent of anaphylaxis reports were attributed to the Pfizer-BioNTech vaccine, 45% to Moderna and 1% to the Johnson & Johnson (J&J) vaccine, which was rolled out in the U.S. on March 2.
As The Defender reported earlier this month, the J&J vaccine contains polysorbate 80, known to trigger allergic reactions. The Moderna and Pfizer vaccines contain polyethylene glycol (PEG), also known to trigger anaphylactic reactions.
The latest news report of an anaphylactic reaction to a COVID vaccine was of a 68-year-old Kansas woman who died a day after receiving the vaccine. According to EMS dispatch records, the woman had an allergic reaction at a vaccine clinic site around 4 p.m. on Tuesday, KMBC reported. She had difficulty breathing and speaking and was injected with an EpiPen.
Kansas Department of Health and Environment spokesperson Kristi Zears told The Wichita Eagle that Evans had an anaphylactic reaction during a waiting period after receiving the shot. She was transported to the hospital and pronounced dead a day later. It is not clear whether Evans had underlying health conditions and the Kansas health agency did not indicate which COVID vaccine was administered.
As Many Workers Resist COVID-19 Vaccines, Calls Grow for State to Make Shots Mandatory
Large pockets of first responders, front-line health workers, and other public-facing employees are so far refusing COVID-19 vaccination by the thousands in Massachusetts, prompting calls for state government and private employers to make getting shots a condition of hiring.
Already, the president of one of the largest senior care operators in the state, Hebrew SeniorLife, has said its facilities plan to require COVID vaccines for new employees later this spring when shots are more widely available. And Attorney General Maura Healey earlier this week suggested that public safety employees, such as State Police and prison workers, should be expected to get the shots.
”[If] you’re going to sign up for public work, and receive a paycheck from the taxpayers of this state who have sacrificed and lost so much . . . [and] you can’t get a vaccination? It’s irresponsible,” Healey said on GBH’s Boston Public Radio, while acknowledging that some may have health conditions that prevent them from getting the shots.
Pfizer Joins Moderna, AstraZeneca in Conducting COVID Vaccine Trials on Children
“Together with our partner BioNTech, we have dosed the first healthy children in a global Phase 1/2/3 continuous study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine,” the company said in a statement to AFP
“We are proud to start this much needed study for children and families eagerly awaiting a possible vaccine option.”
According to details posted on the site clinicaltrials.gov, the company is testing three different dosing levels for use in this age group.
The company is already testing the shots in children aged 12 to 15, and its US emergency authorization covers people aged 16 and up.
For Biden, a New Virus Dilemma: How to Handle a Looming Glut of Vaccine
Biden administration officials are anticipating the supply of coronavirus vaccine to outstrip U.S. demand by mid-May if not sooner, and are grappling with what to do with looming surpluses when vaccine scarcity turns to glut.
President Biden has promised enough doses by the end of May to immunize all of the nation’s roughly 260 million adults. But between then and the end of July, the government has locked in commitments from manufacturers for enough vaccines to cover 400 million people — about 70 million more than the nation’s entire population.
Whether to keep, modify or redirect those orders is a question with significant implications, not just for the nation’s efforts to contain the virus but also for how soon the pandemic can be brought to an end. Of the vaccine doses given globally, about three-quarters have gone to only 10 countries. At least 30 countries have not yet injected a single person.
Pregnant Women Are Protected by Pfizer’s and Moderna’s COVID-19 Vaccines and Pass High Levels of Disease-Fighting Antibodies on to their Babies, Study Finds
The study, published Thursday in the American Journal of Obstetrics and Gynecology, looked at 131 women who received one of the two vaccines between December and March. Eighty-four were pregnant, and 31 were lactating.
Researchers from centers including Harvard, MIT, and Brigham and Women’s Hospital found that the pregnant and lactating women had as strong of an immune response to the vaccines as the 16 women who were not pregnant or lactating.
Rutgers to Require COVID-19 Vaccine for Students
Rutgers University will require the COVID-19 vaccine for students who are enrolled for the 2021 fall semester.
Assurances from the federal government that vaccines will be available for all Americans by the end of May and assessments by public health experts prompted university leaders to adjust the vaccine requirements for the fall semester.
“We are committed to health and safety for all members of our community, and adding COVID-19 vaccination to our student immunization requirements will help provide a safer and more robust college experience for our students,” said Rutgers President Jonathan Holloway.
Students may request an exemption from vaccination for medical or religious reasons.
Students enrolled in fully remote online degree programs and individuals participating in online-only continuing education programs will not be required to be vaccinated.
AstraZeneca: Vaccine Slightly Less Effective, But ‘No Safety Concerns’
AstraZeneca defended itself by saying the latest data were still “consistent” with what it had shared, reported Politico.
This latest twist created another layer of uncertainty for a product already facing dwindling support in Europe following months of confusion and missteps. The repeated blunders risk further eroding public confidence in the vaccine, according to Bloomberg.
“The difference between 76% and 79% is a rounding error, probably just a handful of cases,” said Paula Cannon, a professor of molecular microbiology and immunology at the University of Southern California’s Keck School of Medicine. “But it’s so important for us to be completely transparent and accurate because we are building public trust.”
AstraZeneca, which developed its vaccine in collaboration with scientists at Oxford University, has experienced repeated scrutiny over its clinical trials and safety data beginning with the first data released in the UK, where the company purported to inflate the efficacy of its vaccine while ignoring a manufacturing mistake and failing to include enough participants over 65 to determine efficacy among older patients.
Fake CDC Vaccine ID Cards Being Sold Online In Illinois
“As we shift into requiring COVID vaccination proof to participate in the reopening of society, I think we’re going to have a lot more people using these fraudulent cards,” said Anderson.
“With something as capturing as coronavirus, which coats the entire world, everyone is thinking about it at all times. It’s the most obvious lure for criminals.”
Steve Bernas, the president and CEO of the Better Business Bureau of Chicago says these crimes are some of the worst he’s seen in his 33-year career.
These fraudulent cards could create a security breach at airports.
“If you want to try to get on an airplane and you feel everyone is vaccinated and this person isn’t vaccinated; carrying around a fake card, it’s not good for America or anyone,” said Bernas.
More Than Half of Israelis Receive Both COVID-19 Vaccine Doses
Distribution of the Pfizer/BioNTech vaccine in Israel began in December, with eligibility extended to citizens and residents over the age of 16 – some 69% of the 9.3 million population. People are deemed fully protected a week after receiving the second shot.
In a statement announcing the milestone amid a sustained drop in new infections, Health Minister Yuli Edelstein called on citizens “to follow (health) guidelines so that the coronavirus does not return.”
He said 50.07% of the overall population – or 72.5% of the eligible population – had received both vaccine doses, while 55.96% of the overall population have received the first dose.
Would You Get a COVID-19 Vaccine From Your Dentist? ‘Drillers and Fillers’ Fight Pandemic
And now that the Biden administration is letting dentists and dental students administer vaccines, Americans may now be able to get an inoculation against the deadly virus the next time they get a tooth cleaning.
“As a dentist, I will be very happy to give a shot,” says Acierno, who is also CEO of Schaumburg Illinois-based DecisionOne Dental, a group of dental practices with 33 locations.
In fact, the procedure will be even easier for him than oral shots because vaccine patients won’t be able to fend off needles with their tongues or by clamping their mouths shut.
There’s a growing consensus that an all-hands-on-deck approach is the best way to vaccinate the nation as quickly as possible at a time when experts say that it’s the only way to put an end to the pandemic.
Routine Childhood Vaccines a Concern as Schools Reopen
At a recent briefing, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said CDC orders for childhood vaccines had dropped by about 11 million doses during the pandemic. CDC representatives later explained to U.S. News that data from late February shows total orders for childhood vaccines other than flu vaccines made through the CDC’s Vaccines for Children program were down by 11 million doses when comparing 2020-2021 with 2019-2020.
“When planning for your child’s safe return to childcare programs or their return to school, please check with your child’s doctor to make sure that they are up to date on their vaccinations,” Walensky urged parents, pointing out that the CDC has a catch-up schedule for children who have gotten off track with their vaccines. Her call to action came about a month after the CDC unveiled its first guidance under the Biden administration for safely reopening schools.
COVID-19: Merkel Defends Rollout as Vaccine Pressure Grows
EU leaders are holding virtual talks to discuss vaccine supplies and improving distribution across the 27 nations.
Pressure is mounting upon them to deliver after other countries, like the UK, achieved much faster vaccination.
The European Commission is seeking added controls on vaccine exports.
Such controls could affect supply to the UK, where Prime Minister Boris Johnson has warned against imposing “blockades.”
European Commission head Ursula von der Leyen tweeted that the summit would “ensure that Europeans get their fair share of vaccines.”
Massive Second Wave of Infections Is Emerging in India, Pitting the Virus Against the Vaccine Rollout
On Wednesday, India recorded 53,476 new cases, the highest figure since October. The speed of India’s second wave has alarmed experts, who say it probably reflects changes in behavior, waning immunity among those previously infected, and the influence of new variants. Deaths from the virus are also on the rise in India, with 250 reported on Wednesday.
Compared to many countries, India is in an enviable position when it comes to vaccine supply, thanks to its robust domestic manufacturing capacity. About 50 million people in India, or 4 percent of the population, have received at least one shot. But India has also sent 60 million doses to other countries, a strategy that has raised questions about the pace of India’s rollout at home.
As cases increase, India is racing to ramp up vaccinations. All Indians 45 and older will be eligible for vaccines starting April 1, the government said this week.
‘Nothing Worse Than COVID’ — Spaniards Line Up as AstraZeneca Shots Resume
Along with a dozen other European countries, Spain stopped using the shot early last week amid concerns of a rare blood-clotting condition, but then revoked the suspension after Europe’s medicines agency backed the vaccine.
“We have to put prejudice and urban myths aside and move forward,” civil servant Jose Manuel Plaza said from his car after getting the shot at a drive-through vaccination clinic in the southern province of Huelva.
Covax Shows How Far the World Has Come Since the H1N1 Pandemic, Says Vaccine Expert
Speaking at a virtual press briefing on the Covax scheme, he said that during the H1N1 outbreak poorer countries received vaccines four months after richer countries – and even then allocations were slim.
In the first six weeks, a mere 100,000 doses were shared, while fewer than 10m doses were distributed in 17 countries in the entire first three months of the programme, he said.
While the current vaccine roll out is less than perfect, the estimated quantities the Covax facility – co-led by Cepi, the World Health Organization and Gavi – is currently working towards are far greater this time around.
House Dems Call on Biden To Make COVID Vaccine Mandatory in Military as a Third of Troops Deny Shot
California Congressman Jimmy Panetta led a group of seven Democrats that requested a waiver of informed consent, meaning permission from soldiers to be vaccinated, be issued in a letter sent to Biden on Wednesday. The group cited Pentagon figures that showed one-third of service members offered a vaccine had already refused to take it, while polls have also indicated a high level of resistance to being inoculated in the military. Unlike the general population, military members are obliged to take certain vaccines, although the COVID-19 shots have not yet been made mandatory.
“We write to respectfully request you issue a waiver of informed consent to ensure members of the armed forces receive a COVID-19 vaccine at the earlier opportunity,” the representatives wrote. “Vaccinating every eligible service member will improve readiness and have an immediate and positive impact on the communities in which they serve.”
“Recent media reports have shown overwhelming evidence that disinformation and vaccine skepticism are rampant within our own formations,” they continued. “This is a critical threat to our national security and public health… Requiring DOD to obtain informed consent prior to vaccination is not only harmful to our national security, but contrary to the best interests of service members, their families, communities and colleagues.”
Ukrainian Servicewoman Who Died Had Shown no Adverse Reaction to COVID-19 Vaccine: Ministry
A Ukrainian servicewoman who died two days after taking the AstraZeneca CoviShield vaccine had not complained of any ill effects after taking the shot, a statement on the health ministry’s website said on Wednesday.
The statement urged the public not to jump to conclusions about the death, which is still being investigated, and said the woman had chronic cardiovascular disease and other comorbidities. Nine other people were given the vaccine from the same batch on the same day and had no ill effects, it said.
Scientist to FDA: You Are Ignoring ‘Clear and Present Danger’ Associated With COVID Vaccine
The email is addressed to Dr. Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration (FDA), but Noorchashm copied others, including the FDA’s Peter Marks, several Pfizer executives, reporters at CBS News, Fox News and The New York Times, and other scientists and colleagues.
Here’s Noorchashm’s email:
Dear Dr. Woodcock,
Here I am writing to report to you the death of Mr. Benjamin G. Goodman of NY within a day following vaccination with the J&J COVID-19 vaccine.
This is his obituary. He was 32 and otherwise healthy:
Attached, you may read his mother’s Facebook posting about his death.
Dr. Woodcock, it is untenable for you and your colleagues to be ignoring these death and vaccine complications without lifting a finger to do anything — simply this: These complications are mounting and CDC and FDA’s surveillance systems are missing the signal — the signal is deafening on social media!
And these are NOT Russian bots infiltrating our SM platforms, these are Americans being harmed and ignored … by YOU and our public health system.
As an immunologist, I know that these vaccines are some of the most powerful and effective we’ve ever made. I know them, I understand them and I know that we need them to achieve herd immunity.
But, as I’ve told you before, we are deploying this defensive weapon wildly indiscriminately in the midst of a pandemic outbreak, while many are “the recently infected.” It is my professional opinion as an immunologist and physician that this indiscriminate vaccination is a clear and present danger to a subset of the already infected.
Vaccine Cache in Italy Raises Suspicions as E.U. Plans to Cut Exports
A stockpile of 29 million doses of AstraZeneca’s COVID-19 vaccine that were found languishing in a facility in Italy became the new flash point on Wednesday in the conflict between the pharmaceutical company and the European Union, as the bloc prepared to unveil stringent export restrictions primarily meant to stop drugmakers from sending doses abroad.
The Italian authorities found the vaccines in a site visit, European Union officials said, at a factory near Rome that is contracted to fill and finish COVID-19 vaccine vials for AstraZeneca.
The Italian authorities went to the site after receiving an alert from the European Commission, which found a discrepancy between what the company said it was producing in European Union facilities, and what the facilities themselves were reporting.
The presence of so many doses raised suspicions that the pharmaceutical company was trying to find a way to export them to Britain or elsewhere, something the bloc has demanded that AstraZeneca stop doing until the company fulfills its promises for deliveries.
The European Union was meant to receive more than 100 million vaccine doses from AstraZeneca in the first quarter of this year, but has received only 16.6 million. The supply shortage has helped to derail vaccination efforts across the 27 member countries and contributed to embarrassingly slow inoculation rates on the continent.
Vaccine: Twenty Countries Suspend Injections; Does That Make You “Hesitant?”
The reason for the “pause?” A “small” number of people have developed blood clots.
And now, as I write this, the Wall St. Journal is reporting that European Union medical regulators have decided everything is OK — “the benefits of the shots outweigh the risks.”
Standard boilerplate language for: “we don’t have to explain the vaccine injuries or deaths.”
If you believe just a few people with blood clots caused 20 countries to stop giving the jabs, I have condos on Mars for sale.
Hidden behind the firewall of the vaccine establishment, MANY people are keeling over.
And why wouldn’t they? Governments and pharma companies have rushed a new experimental RNA technology into use, for the first time in history. Prior to the COVID injection, all attempts to force approval of RNA tech had failed; dangerous and deadly over-reaction of the immune system was the reason.
Since I seem to be one of the only people saying this, I’ll say it again: Bill Gates, Fauci, and other rabid vaccinators are in love with RNA tech. It allows vaccines to be produced far more quickly, easily, and cheaply.
For any purported virus, at the drop of a hat, companies can come up with a vaccine. It doesn’t take four years. It takes three months.
Finland Extends Probe of Astrazeneca Jab but to Resume Use for Those Aged 65 and Over
Several European countries stopped administering the shot after reports of a small number of blood disorders, but most have begun using it again after regulators said the benefits outweighed any risks.
“We have not detected people that have turned 65 to have an increased risk of blood clotting so we can resume vaccinating them,” Taneli Puumalainen, chief physician at the Finnish Institute for Health and Welfare said in a press release on Wednesday.
The institute is still looking into two cases of blood clots in Finland and said it needed more time to complete its investigation, which will be finished on April 6 the earliest.
Pfizer Begins Early-Stage Study of Oral COVID-19 Drug
Pfizer Inc has started an early-stage U.S. trial of an oral COVID-19 antiviral therapy that could be prescribed to patients at the first sign of infection, the company said on Tuesday.
The drugmaker, which developed the first authorized COVID-19 vaccine in the U.S. with Germany’s BioNTech SA, said the antiviral candidate showed potent activity against SARS-CoV-2, the virus that causes COVID-19, in lab studies.
Pfizer’s candidate, named PF-07321332, is a protease inhibitor that prevents the virus from replicating in cells.
Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both on their own and in combination with other antivirals, the company said.
Hong Kong Suspends Use of the Pfizer-BioNTech Vaccine After the Discovery of Faulty Packaging
Hong Kong on Wednesday suspended use of the Pfizer-BioNTech vaccine after packaging defects ranging from cracked containers to loose caps were discovered in one batch of doses. The pause dealt a major blow to a city already struggling to inoculate its seven million residents against Covid-19.
Health officials called the halt a precaution, saying that none of the defective vials had been administered to patients and that they had found no health risks.
But if the suspension persists, the Chinese territory may not have enough shots to protect its population while the coronavirus continues to spread. Hong Kong officials were counting on 7.5 million doses of the vaccine, developed by Pfizer of the United States and BioNTech of Germany, to help fill their needs.
The discovery has unleashed a hunt for the origin of the defects, as well as questions about whether more might be out there. The doses were manufactured at BioNTech’s facilities in Germany, while a Chinese company called Fosun Pharma was in charge of transporting, storing and distributing the shots in Hong Kong.
COVID Vaccines Made by End of 2021 Could Inoculate 70% of the World
The extraordinary demand for Covid-19 vaccines and the record speed with which multiple candidates have been produced has transformed the vaccine manufacturing industry, which before the pandemic was producing about 5bn doses a year to inoculate against viruses such as seasonal influenza, measles and mumps.
Manufacturers estimate they will produce about 12bn doses of Covid-19 vaccines alone this year, the analysis showed, with investments in capacity expected to lead to a massive ramping up in supplies over the next months.
Figures from the data firm Airfinity show nearly a billion Covid-19 vaccine doses have been produced in the first four months of this year, but that figure is predicted to balloon to at least 9.4bn by the end of 2021.
“If manufacturers are able to reach their goal of 12bn doses this year and if those doses were purchased and distributed equitably across the world’s population, we could meet much of the world’s needs in 2021,” the Duke researchers said.
Pfizer to Reportedly Develop New Vaccines on Its Own Using mRNA Technology
Pfizer plans to tap the mRNA technology to make new vaccines for other viruses following the success of its Covid-19 shot, which was developed jointly with German partner BioNTech, The Wall Street Journal reported on Tuesday.
The drugmaker said it was ready to pursue mRNA on its own following its experience in the past year working on the COVID-19 vaccine, the WSJ reported, citing an interview with Pfizer Chief Executive Officer Albert Bourla.
It did not, however, disclose any details about the viruses it was targeting.
Pfizer and BioNTech did not immediately respond to Reuters requests for comment.
The success of the technology is prompting drug developers to consider its use in other areas of medicine beyond vaccines, attracting billions of dollars in investment.
Care Home Workers in England Face Mandatory COVID Jabs Under Plans
Care home workers in England could be legally required to have a Covid-19 vaccination under plans being considered by the government.
According to details of a paper submitted to the Covid-19 operations cabinet subcommittee last week and leaked to the Telegraph, the prime minister, Boris Johnson, and the health secretary, Matt Hancock, have agreed to the proposal in order to protect vulnerable residents.
The move would prove highly controversial and could result in legal challenges. The cabinet subcommittee paper warned a large number of social care workers may quit if the change is made, and said that lawsuits on human rights grounds could be possible. A government spokesman insisted “no final decisions have been made” but did not rule out jabs being made compulsory for care workers. The government is also reviewing the introduction of vaccination passports.
If the change is approved it would affect most of the 1.5 million workers in England’s adult social care sector, who would be obliged by law to have a COVID jab.
Why The Credibility of AstraZeneca’s Vaccine Data Matters
What they’re saying: “I think everybody is sort of stunned,” said Jennifer Nuzzo, an epidemiologist at Johns Hopkins. “There are billions of eyeballs on these data.”
- The public rift between a drug company and independent reviewers is highly unusual. And it’s all the more frustrating, experts noted, because this particular trial was designed in part to help quell some of the uncertainty AstraZeneca caused with its other studies.
“It’s one thing for a drug company or sponsor to bungle this on the first go but this is the second time this company has released information that was inaccurate and confusing, and it’s incredibly frustrating,” said Jonathan Kimmelman, a bioethicist at McGill University.
- Experts questioned the overall efficacy rate that AstraZeneca had claimed from previous trials, due to the unusual way the company pooled data from multiple research arms.
- A mistake in the actual administration of those trials also resulted in some patients getting a dosing regimen that the company hadn’t recommended or set out to study.
More recently, some European countries have paused their use of the AstraZeneca vaccine because they were worried it might be causing blood clots, although the research hasn’t shown any evidence of such a link.
Concord Cancels School Due to Bad Reactions to COVID-19 Vaccine
Parents in the SAU 8 district received phone calls, emails, and text messages notifying them there would not be school at just before 6:30 a.m. The alerts stated it was due to the level of teacher absenteeism across the district. The decision was made as principals began fielding calls from educators early on Monday that they were sick.
School Superintendent Kathleen Murphy said the closure was more than just teachers though — many staffers, including district office employees, also got shots Sunday, and reported adverse reactions to them.
“It was related to vaccine shots,” she said of Monday’s school closure. “We received notice from a number of staff, teachers, education assistants, and district staff who were sick, so we were unable to open school in a safe manner.”
All the staffers who were vaccinated received the single dose Johnson & Johnson vaccine.
U.S. Health Officials Accuse AstraZeneca of Misrepresenting Efficacy Data
In a “highly unusual” statement Tuesday, a U.S. health agency said AstraZeneca may have included “outdated information” in its clinical trial results, which may have led to the vaccine maker providing the public with an incomplete view of its efficacy data.
The statement by the National Institute of Allergy and Infectious Diseases (NIAID) came less than a day after the pharmaceutical company said its vaccine was 79% effective against COVID and 100% effective against severe or critical disease and hospitalization.
“We urge the company to work with the Data and Safety Monitoring Board (DSMB) to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the NIAID said.
AstraZeneca immediately responded saying the numbers published Monday were based on a “pre-specified interim analysis with a data cut-off” of Feb. 17. The company promised to “immediately engage with the DSMB to share their primary analysis with the most up-to-date efficacy data” and to issue the results of the primary analysis within 48 hours.
Surgeon Warns Vaccinating People Infected With COVID Could Cause ‘Avoidable Harm’
Dr. Hooman Noorchashm wants people to know that he’s a staunch supporter of the new COVID-19 vaccines, but with one very important warning: People who have already been infected could be at risk of serious injury, including death.
In the interview below on Tuesday’s Tucker Carlson Tonight show, Noorchashm said:
“I think it’s a dramatic error on part of public health officials to try to put this vaccine into a one-size-fits-all paradigm … We’re going to take this problem we have with the COVID-19 pandemic, where a half-percent of the population is susceptible to dying, and compound it by causing totally avoidable harm by vaccinating people who are already infected … the signal is deafening, the people who are having complications or adverse events are the people who have recently or are currently or previously infected [with COVID]. I don’t think we can ignore this.”
As The Defender reported earlier this month, Noorchashm believes that a #ScreenB4Vaccine campaign could save millions from vaccine injuries. The cardiothoracic surgeon and patient safety advocate has been speaking out about the need to screen people before administering the COVID vaccines ever since his initial plea to Pfizer and the U.S. Food and Drug Administration (FDA) failed to generate a satisfactory response.
In a Jan. 26 letter to FDA officials, Noorchashm warned 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.
America Is Now in the Hands of the Vaccine-Hesitant
Vaccine-acceptance rates are typically stagnant, but that doesn’t mean they’re stuck in place. It’s often said that more people would get their flu shots if they only grasped the toll of the disease. The deaths caused by influenza — tens of thousands in the U.S. every year — are usually invisible, so much so that the risk is misperceived. For COVID-19, though, the cost is counted every day. When it nears a big, round number — 10,000, or 100,000, or 200,000, or 400,000, or half a million — front-page headlines follow. This transparency alone might sway the vaccine-hesitant. So too could the thought of returning to a semblance of one’s former life. Get a COVID-19 vaccine, and you can hug your parents: No other vaccination has this perk.
As distribution centers open up to all adults, and more people get their shots, even just the idea of getting immunized could spread through social networks as its own happy contagion, bringing up acceptance rates. “The thing that works best for getting vaccinated is that it gets normalized,” says Maya Goldenberg, a philosopher of science at the University of Guelph, in Ontario, Canada, and the author of a new book, Vaccine Hesitancy: Public Trust, Expertise, and the War on Science. “When vaccination becomes the norm, most people will do it unless they have a really strong inclination not to.”
What might that mean in practice? At the moment, one-fourth of all adults have already gotten at least one dose of their vaccine. Another 35 to 40 percent say they plan to get vaccinated as soon as they can, and about 20 percent are now at maybe. Goldenberg told me that we shouldn’t think of this latter group as being truly undecided. “We know that a lot of people are saying ‘I want to get it, but I don’t want to be first in line.’ Does that count as vaccine-hesitant? I’m inclined to say no.” So even if the nevers never budge, it’s certainly possible that in the next few months, amid the vaccination saturnalia, nearly all the nation’s maybes will come around. In that case, we’ll end up with 80 percent of all adults having their vaccination cards filled out or making their appointments—right in Fauci’s sweet spot for herd immunity.
When Will Kids and Teens Be Vaccinated Against COVID-19?
While there’s a chance that a vaccine will be available to high school and middle school-age children by this fall, younger children may still be months away from vaccination when the upcoming school year begins. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said younger children may have to wait until the first quarter of 2022.
Trials are getting underway, though. Last week, the first children were vaccinated in Moderna’s Phase 2/3 KidCOVE pediatric trial, which includes children ages 6 months to 11 years.
Dr. Buddy Creech, director of Vanderbilt University’s Vaccine Research Program and an investigator in Moderna’s pediatric trials, estimates a Covid-19 vaccine won’t be available to children 11 and younger until November or December, at the earliest.
Krispy Kreme Will Offer Free Doughnuts — All Year Long — to People With COVID-19 Vaccination Cards
Krispy Kreme is upping the incentives for people to get their COVID-19 vaccine.
The chain says it will offer a free original glazed doughnut to anyone who shows their vaccination card for the rest of 2021, starting today. And the offer is not a one-time deal.
Customers can come in any day, at any time, to claim the free treat. No additional purchase is necessary. Krispy Kreme says it also plans to randomly deliver doughnuts to health care workers and volunteers at vaccination centers in the coming weeks.
For Krispy Kreme, it’s the continuation of a series of giveaways that started in 2020. Last year, the company says it gave away over 30 million doughnuts to health care workers, first responders, teachers, coaches, and graduating seniors to help keep spirits up.
Can Your Employer Require You to Get a COVID-19 Vaccine?
Employment attorney Grant Osborne discussed the legality of mandating vaccines in a general sense. He said employers have the right to do so.
“Employers are free, legally speaking, to require employees to submit to vaccinations to ensure a safe and healthy workplace,” Osborne said.
Cogburn’s office plans to enforce the measure by instructing employees to provide vaccination cards to their supervisors. The information would be added to their personnel files.
An underlying health concern is the only reason mentioned in the memo as a reason to opt-out of the mandate. Employees with health concerns have to tell their supervisors.
Osborne said it can run the risk of interfering with HIPPA concerns if the employee is required to disclose protected health information.
The World’s First Oral COVID-19 Vaccine Is Being Prepared for Clinical Trials – Here’s How It Works
Oramed CEO Nadav Kidron, believes the technology could revolutionise the marketplace. He said: “An oral COVID-19 vaccine would eliminate several barriers to rapid, wide-scale distribution, potentially enabling people to take the vaccine themselves at home.
“While ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable in the case that a COVID-19 vaccine may be recommended annually like the standard flu shot.”
The vaccine candidate is expected to commence a clinical study during the second quarter of 2021. Trails are being applied for in multiple countries, including the United States, Israel, Europe and Mexico.
European Trust in AstraZeneca COVID Vaccine Plunges, Poll Shows
Confidence in the safety of AstraZeneca’s COVID vaccine has taken a big hit in Spain, Germany, France and Italy as reports of rare blood clots have been linked to it and many countries briefly stopped using it, poll data showed.
Polling firm YouGov said on Monday it had already found in late February that Europeans were more hesitant about the AstraZeneca vaccine than about those from Pfizer-BioNTech and Moderna and that the clot concerns had further damaged public perceptions of the AstraZeneca shot’s safety.
At least 13 European countries in the past two weeks stopped administering the AstraZeneca shot, co-developed with scientists at Oxford University, after reports of a small number of blood disorders.
Many resumed its use on Friday after the European Medicines Agency regulator said in a preliminary safety review on Thursday that the vaccine was safe and effective and not linked with a rise in the overall risk of blood clots.
EMA did not rule out a possible link, however, with rare cases of blood clots in the brain known as cerebral venous sinus thrombosis (CVST).
New Research Points to Link Between AstraZeneca Vaccine and Blood Clots
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.
Opinion: Did COVID-19 Escape From a Wuhan lab? The WHO Report Can’t Be the Final Word.
So will the final WHO report focus on the Wuhan Institute of Virology? Don’t count on it. Because the same WHO investigators who — responding to media inquiries — confirmed the existence of the sick lab workers immediately played down the importance of the information.
“It was flu season!” WHO investigator Peter Daszak said on Twitter, though he provided no evidence that these lab workers had flu rather than COVID. Fellow investigator Marion Koopmans told NBC News that the lab researchers’ illnesses were “normal” and “there was nothing that stood out. … We’ve really not seen any evidence of [a] credible lab-associated case,” adding that China’s government said the lab workers tested negative for COVID antibodies in March and April last year. In other words, nothing to see here — because the Chinese Communist Party told us so.
No government, no public health official, no one affected by COVID should accept such unserious explanations. For one thing, why is this information emerging only now, more than a year after the public outbreak? When the State Department released its information about the sick lab workers in January, the Chinese government angrily dismissed and condemned the U.S. statement.
In This Nigerian City, Pfizer Fears Loom Over the Vaccine Rollout
Vaccine fears driven by the history of medical experimentation in Africa threaten to undermine the battle to end the pandemic, health officials say, as several nations kick off inoculation campaigns this month.
Nigeria has sought to ease anxieties, deploying teams of public health educators to meet with religious leaders, village chiefs, shop owners, fishermen — voices with sway in their communities. Hesitancy to accept medicine from overseas slowed polio eradication in some areas, and leaders don’t want to see a repeat.
“We cannot just dismiss the skepticism,” said Faisal Shuaib, head of the National Primary Health Care Development Agency, which is in charge of the rollout. “We have to recognize that people have their own concerns. We need to listen to them, and then we have to do the extra work that is required.”
Don’t Be Surprised When Vaccinated People Get Infected
Breakthrough infections, which occur when fully vaccinated people are infected by the pathogen that their shots were designed to protect against, are an entirely expected part of any vaccination process. They’re the data points that keep vaccines from reaching 100% efficacy in trials; they’re simple proof that no inoculation is a perfect preventative. And so far, the ones found after COVID-19 vaccination seem to be unextraordinary.
When breakthrough cases do arise, it’s not always clear why. The trio of vaccines now circulating in the United States were all designed around the original coronavirus variant, and seem to be a bit less effective against some newer versions of the virus. These troublesome variants have yet to render any of our current vaccines obsolete. But “the more variants there are, the more concern you have for breakthrough cases,” Saad Omer, a vaccine expert at Yale, told me. The circumstances of exposure to any version of the coronavirus will also make a difference. If vaccinated people are spending time with groups of unvaccinated people in places where the virus is running rampant, that still raises their chance of getting sick. Large doses of the virus can overwhelm the sturdiest of immune defenses, if given the chance.
CDC Ignores Inquiry Into Increasing Number of Deaths, Injuries Reported After COVID Vaccines
Data released today by the Centers for Disease Control and Prevention (CDC) on the number of injuries and deaths reported to the Vaccine Adverse Event Reporting System (VAERS) following COVID vaccines showed 38,444 reports of adverse events since Dec. 14, 2020.
On March 8, The Defender contacted the CDC with questions about VAERS numbers, reported deaths and COVID vaccine injuries. We provided a written list of questions about how the CDC conducts investigations into reported deaths, the status of investigations on deaths reported in the media, if autopsies are being done, the standard for determining whether an injury is causally connected to a vaccine and the known issues with VAERS — namely whether healthcare providers are reporting all injuries and deaths that might be connected to the COVID vaccine, and what education initiatives are in place to encourage and facilitate proper and accurate reporting. We asked for a reply within two days.
As of today, 11 days later, the CDC has not answered our questions. Instead, when we call them, they respond saying, “they have received our email, they will escalate it and it is in the system.” When we asked if we could speak with the person reviewing the email, we were told that information could not be provided. When we emailed them to follow up, we received no response.
COVID Cases Are Spiking In a Dozen States With High Vaccination Rates
As Europe struggles with a “third wave” of COVID infections that’s forcing more governments to reimpose at least some lockdown measures, the US is finding that the number of newly confirmed cases is climbing again, with some of the biggest week-over-week increases seen in states that had been praised for their vaccination diligence.
COVID cases are spiking in 13 states over the past week. The rebound in new cases in states like Michigan (which is leading the country over the past week with a 53% spike in new cases) Nevada, Maryland and Connecticut are raising concerns about whether new variants discovered in New York State, along with other variants like the Kent Strain (B117) and other international strains.
Notably, Michigan is above the U.S .average in terms of its vaccination rate according to Johns Hopkins Data. State officials are blaming variants for the surge, citing a similar dynamic seen recently in Florida and New York. Other states among the highest in vaccination rates—including West Virginia, Maine and Montana—are also dealing with case spikes. Of the 13 states with rising cases, only two – Mississippi and New Hampshire – have below-average vaccination rates.
U.S. Likely Needs to Include Vaccinating Children to Reach Herd Immunity, Fauci Says
Several more states on Thursday announced COVID-19 vaccines would be available to more people, news that came as the nation’s top infectious disease expert said we might need to inoculate children to reach herd immunity.
But, Dr. Anthony Fauci said people are too focused on the thought of herd immunity — the point at which enough people are protected against the virus to suppress spread — for this novel coronavirus.
“I think we should be careful about wedding ourselves to this concept of herd immunity because we really do not know precisely, for this particular virus, what that is,” Fauci told a Senate hearing.
Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases, said he has been estimating that anywhere between 70% and 85% of the population would need to be vaccinated or otherwise immune to the virus to get to the point of herd immunity.
“We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. We ultimately would like to get and have to get children into that mix,” Fauci said during a hearing of the Senate Health, Education, Labor and Pensions Committee.
More Than 4 in 10 Health-Care Workers Have Not Been Vaccinated, Post-KFF Poll Finds
According to a Washington Post-Kaiser Family Foundation poll, barely half of front-line healthcare workers (52 percent) said they had received at least their first vaccine dose at the time they were surveyed. More than 1 in 3 said they were not confident vaccines were sufficiently tested for safety and effectiveness.
The nationally representative survey of 1,327 front-line healthcare workers, conducted Feb. 11 through March 7, illustrates the challenges ahead as vaccine advocates try to persuade a wider population — with less familiarity with medicine — to get vaccinated.
While about 2 in 10 healthcare workers said they had scheduled a shot or were planning to, 3 in 10 health-care workers said they were unsure about getting vaccinated or not planning to do so. As many as 1 in 6 health workers said that if employers required them to get vaccinated, they would leave their job.
COVID-19 Vaccine Trials for Kids Ramp Up
“It is extremely important to do these vaccine studies in children,” says Stephen Spector, a professor of pediatrics at the University of California San Diego School of Medicine, who is leading a trial of the Moderna vaccine. Herd immunity—the point at which enough people have achieved immunity to largely stop transmission—will require immunizing a minimum of 70–80% of the population, he says. “So in order to get herd immunity, we need to immunize children.”
At the same time, since children are the least likely to develop severe COVID-19, medical researchers say extra caution is warranted before authorizing the vaccines for them. As of March 17, the US Centers for Disease Control and Prevention’s weekly update reported that 226 people under 18 have died with COVID-19 in the country, compared with more than 417,000 people 65 and older and over 517,000 people overall.
“There is not the same degree of urgency for vaccinating children as in older adults; it is just a completely different calculation,” says H. Cody Meissner, chief of the Division of Pediatric Infectious Disease at Tufts Children’s Hospital. “I am certainly in favor of a vaccine for children and adolescents,” he says. “The question is, How thoroughly should the vaccine be evaluated in children before there is a broad authorization to administer it?”
AstraZeneca Vaccinations Resume in Germany After Clot Scare
Germany resumed vaccinations with the coronavirus vaccine made by AstraZeneca on Friday, following a recommendation by European regulators that the benefits of the shot outweigh the risks.
The European Medicines Agency said Thursday that the vaccine is safe but it can’t rule out a link to a small number of rare blood clots reported on the continent, and patients should be told to look out for any warning signs.
The move paved the way for more than a dozen European countries, which had suspended use of the shot over the past week, to begin using it again.
Authorities in Berlin said two large vaccination centers that offer the AstraZeneca shot to people in the German capital will reopen Friday, and people whose appointments were canceled this week will be able to get the vaccine over the weekend without making a new one.
UF Health Participating in Moderna Children’s COVID-19 Vaccine Trial, Looking for Kids Under 12
For the first time, kids under 12 years old are being vaccinated in a trial.
Moderna said it is vaccinating 6,750 kids in the United States and Canada.
In a news release, Moderna CEO Stephane Bancel said, “The pediatric study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in the important younger age population.”
The trial will include kids six months old to 11 years old.
COVID-19 Variant Vaccines in Works at Johnson & Johnson
J&J Chief Executive Alex Gorsky said Thursday he was hopeful J&J’s newly authorized vaccine and other current COVID-19 shots provide some protection against new variants, but booster shots or modified versions of original vaccines might be needed.
“We have to be prepared,” Mr. Gorsky said Thursday. “We should prepare for the worst and hope for the best.”
Biden Plans to Send COVID Vaccines to Canada, Mexico
Press secretary Jen Psaki said the Biden administration is in the process of finalizing efforts to distribute 2.5 million doses to Mexico and 1.5 million to Canada as a “loan.” The details are still being worked out.
“Our first priority remains vaccinating the U.S. population,” Psaki said at the daily briefing. But she added that “ensuring our neighbors can contain the virus is a mission critical step, is mission critical to ending the pandemic.”
The AstraZeneca vaccine has not been authorized for use in the U.S. but has been by the World Health Organization. Tens of millions of doses have been stockpiled in the U.S. should it receive emergency use authorization, sparking an international outcry that lifesaving doses were being withheld when they could be used elsewhere.
Britain’s Boris Johnson to Receive First Dose of Astrazeneca Vaccine, Urges Others to Do the Same
U.K. Prime Minister Boris Johnson on Friday is expected to receive the first dose of the coronavirus vaccine developed by AstraZeneca and the University of Oxford, seeking to reassure the public that the vaccine is safe and effective.
Johnson, 56, has urged other people to get inoculated against COVID-19, citing data from the U.K.’s independent drug regulator that shows the benefits far outweigh the risks.
A flurry of countries around the world suspended the use of the Oxford-AstraZeneca vaccine as a precaution following reports of blood clots in some vaccinated people. Health experts sharply criticized the move, citing a lack of data, while analysts expressed concern about the impact on vaccine uptake as the virus continues to spread.
U.K. and EU regulators have said there was no evidence the vaccine had caused blood clots. The World Health Organization also said the benefits of the Oxford-AstraZeneca vaccine outweigh the risks and has recommended that vaccinations continue.
CDC, WHO Create Threat Levels for COVID Variants
The criteria are meant to clarify how much is known about recent changes to the circulating viruses. The levels also help convey risk.
The new designations are “variant of interest”; “variant of concern”; and “variant of high consequence.”
- A variant of interest has caused discrete clusters of infections in the United States or in other countries, or seems to be driving a surge in cases. It also has gene changes that suggest it might be more contagious or that may help it to escape immunity from infection or vaccination. Therapeutics and tests may not work as well against it. The CDC is watching three of these.
- A variant of concern has been proven through scientific research to be more contagious or to cause more severe disease. It may also reduce the effectiveness of therapeutics and vaccines. People who have previously had COVID-19 may become reinfected by the new strain. The CDC is tracking five of these.
- A variant of high consequence causes more severe disease and greater numbers of hospitalizations. It has also been shown to defeat medical countermeasures, such as vaccines, antiviral drugs, and monoclonal antibodies. So far, none of the variants meets this definition.
FDA, CDC Advisers Say to Expect a lot of Questions About AstraZeneca COVID-19 Vaccine
AstraZeneca is expected to apply in the next few weeks for emergency use authorization for its COVID-19 vaccine in the US, and if and when it does, advisers to the US Food and Drug Administration and the US Centers for Disease Control and Prevention will likely have questions.
Lots of questions.
In interviews with CNN, several vaccine advisers to the US government did not cast doubt as to whether AstraZeneca’s vaccine would ultimately gain emergency use authorization from the FDA. They did, however, say the company’s application will likely bring up issues that didn’t arise when the three COVID-19 vaccines currently used in the United States — made by Pfizer, Moderna and Johnson & Johnson — were considered for their own emergency use authorizations.
“It’s clear more questions have been raised about the AstraZeneca vaccine than about any of the other vaccines which are now authorized in the US,” said Dr. Arnold Monto, acting chair of the FDA’s Vaccines and Related Biological Products Advisory Committee, which reviews vaccine applications and advises the FDA on whether they should be authorized.
First Baby in U.S. Born With Antibodies Against COVID-19 After Mom Receives Dose of Moderna Vaccine While Pregnant
At 36 weeks pregnant, a South Florida frontline health care worker received her first shot of the
Doctors believe the newborn marks the first known case of a baby born with coronavirus antibodies in the U.S., which may offer her some protection against the virus.
Dr. Paul Gilbert and Dr. Chad Rudnick presented their findings in a preprint study, meaning it has not yet been peer-reviewed. They found that the antibodies were detected at the time of delivery, after analyzing blood from the baby’s umbilical cord taken immediately after birth and before placenta delivery.
Zoo Vaccinates Apes to Protect Both Animals and Humans From COVID-19
On Jan. 11, a troop of eight gorillas at the safari park tested positive for the coronavirus. They were quarantined, received treatment, and are now recovering.
“We’re seeing their everyday personalities and vivaciousness coming back, so we’re very excited that we were able to get them through it,” said Peterson.
Since the outbreak among the gorillas at the safari park, the zoo decided to vaccinate its apes. Six bonobos, four orangutans, and three gorillas have since gotten shots. Among them was Karen, the first orangutan to have open heart surgery back in 1994.
As the pace of COVID-19 vaccinations speeds up across the country, zoos across the country are considering whether to give shots to apes and other animals that may be susceptible to the virus.
Experiencing Side Effects From a COVID Vaccine? CDC Wants to Hear From You.
Shortly after the coronavirus pandemic began, scientists started developing and testing COVID-19 vaccines in the lab in eager volunteers. Clinical trials showed the shots were safe and effective.
Now, even as millions receive a vaccine, health experts continue to monitor the shots’ safety — and they want to hear from you.
V-safe is a smartphone-based tool that allows recently vaccinated people to share any side effects and their severity with the Centers for Disease Control and Prevention. It’s a tool that not only checks in on you with text messages and health surveys, but it also “helps keep COVID-19 vaccines safe — for you and for everyone.” And depending on your health questionnaire answers, someone from the CDC may call to check on you.
As of March 15, V-safe is available in English, Korean, simplified Chinese, Spanish and Vietnamese.
All you need is a smartphone and information about your COVID-19 vaccine, including the date of your first dose if you received a two-dose shot and the name of the vaccine, all of which can be found on your vaccination record card. If you lose your card, you can contact your health care provider or the center that administered your vaccine.
COVID Vax in the Immunosuppressed: Reason for Concern
The day that the FDA granted the Pfizer COVID-19 vaccine an emergency use authorization, we launched a national study of vaccine immune responses in immunosuppressed solid organ transplant recipients. Among 436 COVID-naïve participants who received a first dose of mRNA vaccine, only 17% mounted detectable antibodies to SARS-CoV-2. This is in stark contrast to immunocompetent people who were vaccinated, of whom 100% mounted detectable antibody; that was true for people who had received either the Pfizer-BioNTech or Moderna vaccine. We also found that those taking anti-metabolites, such as mycophenolate or azathioprine, were about five times less likely to develop antibody responses (8.75% detectable antibody in those taking anti-metabolites versus 41.4% in those not taking them).
Naturally, we were disappointed to see these findings, as we were hoping to be able to tell our immunosuppressed patients that the vaccines seemed to work well for them. Given this observation, the CDC should update their new guidelines for vaccinated individuals to warn immunosuppressed people that they still may be susceptible to COVID-19 after vaccination. As the CDC guidelines are currently written, they assume that vaccination means immunity. Our study shows that this is unlikely for most transplant recipients, and one could guess that our findings (especially those concerning anti-metabolites) could also apply to other immunosuppressed patients, such as those with autoimmune conditions.
Of note, our previous research has not found that immunosuppressed transplant patients are at increased risk of COVID-19 mortality as we thought might be the case. But regardless, the vaccine does not seem to work as well in this same population.
U.S. Could Be on the Cusp of COVID-19 Infection Surge Officials Have Been Dreading, Expert Warns
Health officials have repeatedly warned about a potential fourth surge as state leaders eased restrictions and several lifted mask mandates. The first warning sign came when case numbers, after weeks of steep declines, appeared to level off — with the country still averaging tens of thousands of new cases daily. That kind of plateau previously predicted surges, some experts have said.
Cases of the worrying variants — notably the highly contagious B.1.1.7 variant — have also climbed and are set to become the dominant strain by the end of March or early April.
Meanwhile, governors and local leaders have eased restrictions on indoor gatherings, citing fewer Covid-19 cases and more vaccinations. And spring break crowds are gathering in Florida and nationwide air travel numbers are hitting pandemic-era records.
CDC Announces Funding to Support COVID-19 Testing, Advance Health and Equity
The Centers for Disease Control and Prevention today allocated $10 billion to states and territories from the American Rescue Plan Act to support testing to screen teachers, staff and students for COVID-19 to help reopen schools.
It expects to make final awards to support the screening testing to health departments in early April.
In addition, state, local and territorial public health departments may apply through April 30 for a portion of $2.25 billion in grants to address COVID-19-related health disparities among high-risk and underserved populations, including racial and ethnic minority groups and people in rural areas, the agency announced. Funded by the Coronavirus Response and Relief Supplemental Appropriations Act, the grants will support efforts to improve testing and contact tracing, develop prevention and mitigation resources and services, improve data collection and reporting, expand infrastructure and mobilize partners.
Moderna Chief: COVID-19 Vaccine Not Expected to Be Unsafe for Children
In an exclusive interview with Savannah Guthrie on the Today show, Dr. Stephen Hoge said his company has begun testing its vaccine on children aged from six months up to 12 years. The new trial, likely to take most of this year, will involve nearly 7,000 children in the U.S. and Canada.
“We certainly have not seen anything concerning in any of our prior work that would suggest we can’t use the vaccine in children,” he said.
In a separate study which began in December, Moderna was also testing its vaccine in adolescents between 12 and 18 years old. Hoge hopes the data from that trial will arrive by the summer so that children in that age group can be vaccinated going into the new school year.
Poland Official Calls AstraZeneca Scare ‘Planned Disinformation’ as Europe Divides Over Shot
Michal Dworczyk, the chief of staff for Poland’s Prime Minister, said Tuesday that he believes growing safety concerns over the AstraZeneca vaccine could be a result of “a planned disinformation campaign.” He also said that the country will continue to administer the shots.
But as of Tuesday, 17 European countries have suspended the use of the vaccine over reports that the inoculation could lead to dangerous blood clots, also known as “thromboembolic events.”
There have been 37 reports of blood clots out of more than 17 million people vaccinated with the shot in the European Union (EU) and Britain. There have also been cases of people dying suddenly after receiving the shot in Italy, but it has not been confirmed whether those incidents are directly related to the vaccine.
The 17 countries that have suspended or halted the vaccine are Austria, Denmark, Estonia, France, Germany, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Romania, Slovenia, Spain and Sweden.
Trump Urges Americans to Get COVID-19 Vaccine: ‘I Would Recommend It’
Former President Donald Trump on Tuesday urged Americans to get vaccinated to help curb the COVID-19 pandemic, calling it “safe” and “something that works.”
“I would recommend it and I would recommend it to a lot of people that don’t want to get it and a lot of those people voted for me, frankly,” Trump told Fox News’ Maria Bartiromo.
“But again,” he continued, “we have our freedoms and we have to live by that and I agree with that also. But it is a great vaccine. It is a safe vaccine and it is something that works.”
The comments — which amount to Trump’s most energetic endorsement of vaccination — come as vaccine hesitancy among Republicans continues to threaten the US’ path to herd immunity. While 92% of Democrats either have gotten vaccinated or want to get vaccinated, that number plummets to 50% among Republicans, a CNN poll conducted by SSRS shows.
Pfizer Exec Sees ‘Significant Opportunity’ to Increase COVID Vaccine Price for Annual Booster Shot
While addressing investors at the virtual Barclays Global Healthcare Conference last week, Pfizer CFO Frank D’Amelio noted they could raise prices when the virus becomes endemic, meaning it’s regularly found in clusters around the globe, according to a transcript of the conference posted on Pfizer’s website.
Current vaccine pricing models are pandemic-related, D’Amelio explained. After the pandemic is defeated and “normal market conditions” arrive, he noted the window would open for a “significant opportunity … from a pricing perspective.”
The possibility of additional applications for the COVID vaccine may also present itself. A third dose could be needed for variants and regular booster shots, D’Amelio said.
“We believe it’s becoming increasingly likely that an annual revaccination is going to take place,” he said. “Factors like efficacy, booster ability, clinical utility will basically become very important.”
Clarity for Catholics: It’s OK to get Johnson & Johnson COVID-19 vaccine – if It’s the Only One Available
Catholics might be somewhat confused by reports on differing messages about the acceptability of the Johnson & Johnson COVID-19 vaccine due to a cell line from an abortion being used in its production.
The differences have been resolved and Catholic teaching is clear: Catholics have a moral duty to protect themselves and others from COVID-19 by being vaccinated. However, if given the choice, they should avoid the Johnson & Johnson vaccine, according to the Vatican and the U.S. Conference of Catholic Bishops.
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
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).
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.