Covid News Watch
Paul Clashes With Fauci Over Child Vaccinations + More
Paul Clashes With Fauci Over Child Vaccinations
Sen. Rand Paul (R-Ky.) on Wednesday clashed with White House medical adviser Anthony Fauci about whether children who were previously infected with COVID-19 need to be vaccinated, the latest in his long-running feud with the nation’s top infectious diseases doctor.
During a Senate hearing about the administration’s response to monkeypox, Paul played a clip of Fauci on C-SPAN in 2004. In the clip, Fauci told someone who was infected with the flu they did not need a flu shot. “If she got the flu for 14 days, she’s as protected as anybody can be because the best vaccination is to get infected yourself,” Fauci said in the video.
Paul then pressed Fauci on why his comments about COVID-19 differed from what he said about the flu, and why he recommended parents vaccinate their children even if they’ve previously been infected with the coronavirus.
“What you’re doing is denying the very fundamental premise of immunology that previous infection does provide some sort of immunity,” Paul said.
How Bill Gates and Partners Used Their Clout to Control the Global COVID Response — With Little Oversight
When COVID-19 struck, the governments of the world weren’t prepared. From America to Europe to Asia, they veered from minimizing the threat to closing their borders in ill-fated attempts to quell a viral spread that soon enveloped the world. While the most powerful nations looked inward, four non-governmental global health organizations began making plans for a life-or-death struggle against a virus that would know no boundaries.
What followed was a steady, almost inexorable shift in power from the overwhelmed governments to a group of non-governmental organizations, according to a seven-month investigation by POLITICO journalists based in the U.S. and Europe and the German newspaper WELT. Armed with expertise, bolstered by contacts at the highest levels of Western nations and empowered by well-grooved relationships with drug makers, the four organizations took on roles often played by governments — but without the accountability of governments.
The four organizations had worked together in the past, and three of them shared a common history. The largest and most powerful was the Bill & Melinda Gates Foundation, one of the largest philanthropies in the world. Then there was Gavi, the global vaccine organization that Gates helped to found to inoculate people in low-income nations, and the Wellcome Trust, a British research foundation with a multibillion-dollar endowment that had worked with the Gates Foundation in previous years.
Finally, there was the Coalition for Epidemic Preparedness Innovations, or CEPI, the international vaccine research and development group that Gates and Wellcome both helped to create in 2017.
“What makes Bill Gates qualified to be giving advice and advising the U.S. government on where they should be putting the tremendous resources?” asked Kate Elder, senior vaccines policy adviser for the Doctors Without Borders’ Access Campaign.
Reports of Acute Adverse Events in mRNA COVID Vaccine Recipients After the First and Second Doses in Japan
Mass vaccination against coronavirus disease 2019 (COVID-19) is ongoing in many countries worldwide. This study reports the occurrence of acute adverse events among vaccine recipients at a mass vaccination center in Japan.
The most common event was vasovagal syncope/presyncope, followed by acute allergic reactions. The occurrence rate of vasovagal syncope/presyncope was highest in the young population of those aged 16–29 years, but such age dependency was not apparent in acute allergic reactions.
Both symptoms were more prevalent in women than in men. Vasovagal syncope/presyncope occurred mainly within 20 minutes of the injection, whereas nearly half of the episodes of acute allergic reactions occurred after 20 minutes.
Report Details ‘Massive Global Failure’ in Response to COVID — The Lancet Commission Calls for Transformation of WHO, More Investment for Pandemic Preparedness
The Lancet Commission called for a major overhaul of the World Health Organization (WHO) and global health policy following the estimated deaths of more than 17 million people worldwide as a result of the COVID-19 pandemic.
The Commission recommended that the WHO “be transformed and bolstered by a substantial increase in funding,” as well as “increased and more effective investment for both pandemic preparedness and health systems in developing countries, with a focus on primary care, achieving universal health coverage and disease control more generally.”
To address the COVID-19 pandemic, a global vaccine-plus strategy needs to be established, combined with public health and financial measures to control infection, the report noted.
Moreover, the origin of SARS-CoV-2 needs to be found, which will require “unbiased, independent, transparent and rigorous work by international teams in virology, epidemiology, bioinformatics and other related fields.”
The Number of People Working Remotely Tripled During COVID
The number of people primarily working from home tripled between 2019 and 2021, per survey results released Thursday by the U.S. Census Bureau.
Why it matters: The new figures provide a fresh look into how the pandemic upended how Americans work, play and live. By the numbers: 17.9% of people primarily worked from home in 2021, compared with 5.7% in 2019, per the survey results.
Nearly half, 48.3%, of workers in Washington, DC, worked from home in 2021, the highest percentage of remote workers in the country, per the Census Bureau.
What they’re saying: “Work and commuting are central to American life, so the widespread adoption of working from home is a defining feature of the COVID-19 pandemic,” Michael Burrows, a statistician in the Census Bureau’s Journey-to-Work and Migration Statistics Branch, said in a statement.
Johns Hopkins Is Reducing Its COVID Data Tracking
Johns Hopkins University is scaling back how much and how frequently it tracks COVID-19 pandemic metrics due to a slowdown in local data reporting, the university confirmed to Axios.
Why it matters: There will be less attention on COVID case numbers and deaths, which could leave Americans in the dark about future surges.
Details: The university’s data dashboard — which helped track case numbers, deaths and other metrics — will begin a slowdown on Sept. 21 since there is less reporting data available in the U.S. and around the world, according to university officials.
What they’re saying: “We have seen a dramatic shift in the way that state and local governments not only collect this data but share it publicly,” Beth Blauer, data head for the university’s Coronavirus Resource Center, told Wall Street Journal. “That deeply constrains the way that we can actually report.”
EU Ignores Information Request in Probe Over Massive Pfizer COVID Vaccine Order
The European Court of Auditors wants to know how the bloc clinched its biggest COVID-19 vaccine contract — and whether there was anything untoward in text messages between European Commission (EC) President Ursula von der Leyen and Pfizer chief Albert Bourla. So far, however, the EU budget watchdog’s probe has been met with silence.
In a report issued Wednesday, the Court of Auditors said it had asked the Commission for details on the preliminary negotiations around Europe’s third vaccine contract with Pfizer for its BioNTech-partnered mRNA shot Comirnaty.
“It is the biggest COVID-19 vaccine contract signed by the Commission and will dominate the EU’s vaccine portfolio until the end of 2023,” the Court of Auditors noted.
Despite the request for detail on aspects of the deal like scientific expert advice, discussion records and term agreements, “none was forthcoming,” the watchdog said in its report.
Long COVID Is Keeping Millions out of Work — and Worsening Labor Shortage in the U.S.
We’ve all seen the headlines about labor shortages, worker attrition, or — as many mainstream media outlets refer to it — “the Great Resignation.”
It’s true: since 2020, a record number of people have quit their jobs. The trend is ongoing, and some argue quitting is contagious. But, there’s another contagion that’s probably causing people to leave the workforce in droves.
Since 2020, there have been more than 95m recorded U.S. COVID-19 cases, 1 million deaths and ongoing reports of COVID-induced chronic illness and disability, known as long COVID.
A recent study by the Centers for Disease Control and Prevention estimated that long COVID affects one in five people infected with SARS-CoV-2. A recent Brookings Institution analysis found that as many as 2 to 4 million people may be out of work as a result. With more than 11 million U.S. jobs vacant, it’s plausible that up to one-third of current labor shortages are due to long COVID.
Sheldon Jacobson and Janet Jokela: Will Vaccine Fatigue Affect How Many People Get the Bivalent Booster?
Pfizer’s and Moderna’s bivalent boosters, which are now available to many age groups, offer protection against the original COVID-19 virus plus the BA.4 and BA.5 Omicron subvariants. Is the nation ready for yet another COVID-19 vaccine shot?
Do people have sufficient trust to get yet another shot? Testing of the bivalent boosters was done primarily on animals, not people, though there is no reason to believe that they are unsafe. What remains less clear is their potential effectiveness in the field.
Vaccine uptake has been persistently dropping, as many have become vaccine-fatigued. Though the number of COVID-19 cases, hospitalizations and deaths continues to be somewhat high, they have declined over the past two months and continue to show an encouraging downward trend.
FDA Warns Monkeypox Could Mutate if Antiviral Drug Is Overused
The monkeypox virus is only one mutation away from evading a key antiviral drug being used to treat at-risk patients, federal health officials are now warning — and they’re urging doctors to be “judicious” in prescribing the sought-after treatment.
The new FDA guidance for the antiviral drug known as tecovirimat, or Tpoxx, was published this week online and in updated labeling.
The regulator says lab and animal studies, and evidence from a human case of this family of viruses, suggest monkeypox has “several genetic pathways” to evolve resistance to tecovirimat. Many “require only a single amino acid change,” the FDA said.
“Most patients with intact immune systems really need supportive care and pain control, but often do not need to be stepped up to antiviral treatment,” the Centers for Disease Control and Prevention’s Dr. Sapna Bamrah Morris said over the weekend, in a webinar hosted by the Infectious Diseases Society of America.
Senators Press Biden Administration on ‘Unacceptable’ Monkeypox Response; Officials Defend Their Work
At a congressional hearing on Wednesday with the nation’s leading public health officials, senators on both sides of the aisle criticized the Biden administration’s monkeypox response.
The strongest rebuke came from North Carolina’s Richard Burr, the ranking Republican member of the Senate Committee on Health, Education, Labor and Pensions (HELP), who labeled the government’s handling of monkeypox a “catastrophic failure” reminiscent of the onset of COVID-19 and implored officials to “do better.”
“You repeated each of the mistakes from the early days of the COVID response, and the cultural arrogance from public health officials who are supposed to be at the forefront of our response let this country down again,” Burr told the officials: Centers for Disease Control and Prevention Director Rochelle Walensky; National Institute of Allergy and Infectious Diseases Director Anthony Fauci; Food and Drug Administration Commissioner Robert Califf and Assistant Secretary for Preparedness and Response Dawn O’Connell.
Iowa Nurse Fired After Improperly Administering Monkeypox Vaccines
The Polk County Health Department has fired a nurse who incorrectly administered the monkeypox vaccine to residents, despite having received the proper training.
The county health department said Cheryl Sondall, an on-call nurse who had worked for the department for several years, chose not to follow protocol when she administered the vaccine to five patients during a clinic last week.
Nola Aigner Davis, the department spokesperson, said the vaccine was supposed to be administered intradermally, or between the layers of the skin. Instead, the shots were given subcutaneously, or in the fatty tissue under the skin.
COVID End ‘in Sight,’ Deaths at Lowest Since March 2020 + More
WHO: COVID End ‘in Sight,’ Deaths at Lowest Since March 2020
The head of the World Health Organization said Wednesday that the number of coronavirus deaths worldwide last week was the lowest reported in the pandemic since March 2020, marking what could be a turning point in the years-long global outbreak.
At a press briefing in Geneva, WHO Director-General Tedros Adhanom Ghebreyesus said the world has never been in a better position to stop COVID-19.
“We are not there yet, but the end is in sight,” he said, comparing the effort to that made by a marathon runner nearing the finish line. “Now is the worst time to stop running,” he said. “Now is the time to run harder and make sure we cross the line and reap all the rewards of our hard work.”
The WHO reported that the Omicron subvariant BA.5 continues to dominate globally and comprised nearly 90% of virus samples shared with the world’s biggest public database. In recent weeks, regulatory authorities in Europe, the U.S. and elsewhere have cleared tweaked vaccines that target both the original coronavirus and later variants including BA.5.
What Is Centaurus? New COVID Subvariant Found in Florida, Europe
COVID-19 subvariants are still being discovered more than two-and-a-half years after lockdowns took place. BA.2.75, a recent coronavirus subvariant of the Omicron variant, has increased COVID-19 cases, specifically in Florida and Europe.
Also known as Centaurus, BA.2.75 was first discovered in India early this spring and was christened by a Twitter user who decided to name the subvariant after a constellation. While the name is becoming popular, the WHO has not yet adopted the name.
While, according to Medical News Today, Omicron is still the most prominent variant in the U.S., the BA.2.75 subvariant, reports show, when it was discovered, was spreading faster than other Omicron subvariants.
The World Health Organization (WHO) hasn’t designated BA.2.75 as a variant of concern, but it is monitoring the strain. WHO Director-General Tedros Adhanom Ghebreyesus spoke at the Member State Information Session in July in which he first announced the organization was closely tracking the subvariant.
Why We Need to Be Talking About Vaccines That Offer ‘Mucosal Immunity’
As the U.S. rolls out updated mRNA-based COVID shots, a growing chorus of experts say it’s a mistake not to focus on treatments that boost immunity through mucous membranes.
Next-generation nasal or oral vaccines could quickly boost the immune response in the very airways where COVID-19 enters the body and ultimately break our reliance on the constant development of reformulated shots to target new variants of concern. But the U.S. isn’t putting money into such products, which experts say could augment current vaccines on the market.
Driving the news: China made headlines this month for the emergency approval of CanSino’s inhaled COVID-19 vaccine. Last week, India approved Bharat Biotech’s intranasal vaccine for emergency use.
Mucosal immunity is a key compartment in our immune system, different from the antibody response in the blood that’s stimulated by vaccine shots, said Michael Mina, an epidemiologist and chief scientific officer for at-home testing company eMed.
Got COVID? Flushing out Nasal Passages Could Cut Severity
U.S. News & World Report reported:
Battling COVID and eager to do anything that will limit you to a mild infection? Grab a neti pot, a new study advises. Flushing your sinus cavity twice daily with a mild saline solution can significantly reduce a COVID patient’s risk of hospitalization and death, researchers report.
“We found an 8.5-fold reduction in hospitalizations and no fatalities compared to our controls,” said senior author Dr. Richard Schwartz. He’s chairman of the Department of Emergency Medicine at the Medical College of Georgia at Augusta University. “Both of those are pretty significant endpoints,” Schwartz said in a college news release.
For the study, 79 COVID patients self-administered nasal irrigation using saline water mixed with either povidone-iodine (the brown antiseptic used in surgery) or baking soda. They started doing this within 24 hours of testing positive.
The researchers suspect that saline — salt water — inhibits the COVID virus’ ability to infect cells in the nasal cavity, mouth and lungs. Saline irrigation also appears to help limit the severity of patients’ symptoms. Patients who more diligently stuck to the twice-daily schedule reported quicker resolution of symptoms, the researchers said.
Take Whatever COVID Booster You Can Get, Says Head of EU Drugs Watchdog
People in Europe should take whatever COVID-19 booster is available to them in the coming months, Emer Cooke, Executive Director of the European Medicines Agency (EMA), said in a Reuters Next Newsmaker interview ahead of an expected autumn rise in infections.
Apart from the original COVID vaccines, the EMA has endorsed a number of Omicron-adapted vaccines in recent weeks.
In an interview with the weekly WirtschaftsWoche on Friday, the head of the German association of family doctors, Ulrich Weigeldt, criticized the approval of two different types of variant-adapted vaccines.
“Patients are confused and have a lot of questions about the new vaccines,” he was quoted as saying.
Israel to Roll out Adapted COVID Booster This Month, Official Says
Israel will offer the updated COVID-19 booster shots from Pfizer (PFE.N)/BioNTech (22UAy.DE) designed to combat the Omicron BA.4/5 subvariants by the end of September, a senior health official said on Wednesday.
Israel’s coronavirus task force chief Salman Zarka urged those in risk groups to take the booster along with a flu shot, though anyone above the age of 12 and at least three months from a previous shot or COVID-19 illness would be eligible.
Pfizer/BioNtech’s so-called bivalent vaccine targets the currently circulating BA.4/5 as well as the strain of the virus that originally emerged in China in December 2019.
U.S. Now Among Countries Confirmed With Circulating Vaccine-Derived Poliovirus: CDC
International Business Times reported:
The U.S. is now among the countries confirmed to have circulating vaccine-derived poliovirus (cVDPV). Authorities are urging people to get immunized to prevent the “debilitating” disease.
The confirmation comes amid the detection of polioviruses in New York, the Centers for Disease Control and Prevention (CDC) noted in a statement Tuesday. According to the agency, the case of paralytic polio in an unvaccinated adult in Rockland County, as well as the detection of the virus in wastewater in several other counties, suggests continued transmission.
These two factors also meet the World Health Organization’s (WHO) criteria for cVDPV. This means that the U.S. is now on the list of about 30 countries with cVDPV.
As the agency explained, the vaccine-derived poliovirus (VDPV) is a strain related to the weakened version of the virus that’s in the oral polio vaccine.
Pfizer Starts Late-Stage Trial of mRNA-Based Flu Vaccine
Pfizer Inc. (PFE.N) said on Wednesday it had started a late-stage U.S. trial of an influenza vaccine involving 25,000 patients, among the first such studies for a messenger RNA flu shot.
The company said that the first participants had been dosed with the vaccine, which is based on the same technology used in its widely-used COVID-19 shot developed in partnership with Germany’s BioNTech SE (22UAy.DE).
Messenger RNA technology allows changing the vaccine strains relatively faster, and Pfizer expects this flexibility and its rapid manufacturing to potentially allow better strain matches in future years.
Early-stage data from Moderna Inc.’s (MRNA.O) flu vaccine last year disappointed investors after it showed the company’s mRNA-based flu vaccine was no better than the already approved shots in the market. Moderna, though, also started a late-stage trial of its flu vaccine in June this year.
CDC Warns of Increase in Respiratory Illness Among Children That Could Lead to Polio-Like Muscle Weakness
Doctors across the U.S. have seen an increase among children of a respiratory virus that can cause polio-like muscle weakness.
In most cases, enterovirus D68 (EV-D68) causes a respiratory illness with mild symptoms. It can, however, result in a condition called acute flaccid myelitis (AFM) which can cause inflammation of the spinal cord. Those suffering from AFM can have trouble moving their arms while others experience muscle weakness. In severe cases, it can lead to respiratory failure or life-threatening neurologic complications.
According to an alert issued by the Centers for Disease Control and Prevention last week, pediatric hospitalizations are on the rise among patients with severe respiratory illness who tested positive for rhinovirus (RV) and/or enterovirus (EV). Some of the patients have also tested positive for EV-D68 — and hospital sites are reporting a higher proportion of EV-D68 patients compared to previous years.
Monkeypox Infections Reported by Colleges Raise Concerns of Campus Spread
When Pennsylvania State University junior Nick Ribaudo got an email last month saying that a fellow student had tested positive for monkeypox, his first thought was, “Oh boy, here we go again.”
Several U.S. colleges have confirmed cases of the virus, raising concerns as students return to campus for the fall semester. That’s especially so as many students, like 22-year-old Ribaudo, saw earlier school years cut short or moved online due to COVID-19.
Bill Gates Says He’s Taken the Brunt of COVID Conspiracy Abuse Because People Don’t Know Anthony Fauci Outside the U.S. + More
Bill Gates Says He’s Taken the Brunt of COVID Conspiracy Abuse Because People Don’t Know Anthony Fauci Outside the U.S.
Since the outbreak of COVID-19, Bill Gates through the Bill & Melinda Gates Foundation has spent over $2 billion to strengthen the global response to the pandemic by making vaccines available to lower-income countries and funding the development of antivirals or immunotherapies.
But in the minds of a small sector of the population, the Microsoft founder, along with Anthony Fauci, chief medical adviser to the U.S. President, did a lot more: They orchestrated the whole pandemic as a way of controlling the population.
While the theories were founded in the U.S. — mainly by QAnon conspiracy theorists — and have engulfed both Gates’ and Fauci’s domestic work in the COVID-19 response, when the rumors spread to Europe, it was Gates who bore the brunt of the abuse due to his global status as Microsoft founder.
New York’s COVID State of Emergency to Expire, Says Gov. Hochul
New York’s COVID-19 state of emergency is coming to an end, Gov. Hochul announced on Monday. The governor said she will not extend special pandemic powers that included a suspension of state contract rules and the easing of regulations related to hospitals and healthcare workers.
The move comes amid falling case numbers as well as criticism from Republicans who have accused Hochul of granting sweetheart deals to donors.
Hochul has already scaled back many COVID-era safety guidelines, including relaxing rules for schools and dropping mask mandates for public transportation.
Several other health-related emergency declarations remain in place as the state continues to face a monkeypox outbreak and officials attempt to increase polio vaccinations after the first U.S. case of the disease was recorded in New York this summer.
Are Doctors Getting Their COVID Boosters? — MedPage Today Asked a Dozen Doctors About Their Plans for the Latest Bivalent Shots
Now that bivalent Omicron BA.4/5 COVID boosters are becoming more widely available, MedPage Today asked about a dozen physicians if and when they’re planning to get the latest COVID shots.
Many said they would take their boosters right away, but a few had other plans — including not taking a booster at all.
Moderna Shot Copied by WHO’s Africa Hub May Be Made Globally
Afrigen Biologics & Vaccines plans to start human trials of its COVID-19 vaccine candidate by May, part of a World Health Organization-backed plan to develop locally-made inoculations in the developing world.
Afrigen, which is part of the WHO’s mRNA vaccine technology transfer hub in Cape Town, said in a joint statement the vaccine has shown “a strong immune response” in pre-clinical trials in mice. The vaccine was made by copying the publicly-available sequence of the Moderna Inc. shot provided by Stanford University.
The next stage, the so-called phase 1, 2 trial, will involve about 150 people at sites near Cape Town with the aim of including both vaccinated and unvaccinated people and proving whether it can be used as an initial dose or a booster, said Petro Terblanche, Afrigen’s managing director.
The locally-developed shots could end up being made by at least 15 production facilities in low and middle-income countries around the world.
COVID Caused Huge Shortages in U.S. Labor Market, Study Shows
Research into the lingering effects of COVID-19 on the U.S. workforce has confirmed what anybody who has waited an extended time for a delivery — or been unable to get a restaurant table — already knows: the pandemic has caused massive shortages in the labor market.
On top of the quarter-million people of working age who have died from coronavirus, at least twice that number across all ages have permanently disappeared from the workforce, the analysis by the National Bureau of Economic Research shows.
Other studies have shown the impact on the workforce of long COVID, where symptoms remain months or years after the initial infection has passed. A Brookings study estimated last month that as many as 2.4 million have missed work, are temporarily absent or are working reduced hours because of the lingering effects of the virus.
However, this new study focuses more on the apparent effect on labor supply caused by the pandemic and those who have permanently stopped working — through choice or necessity — as a result of their sickness.
Thousands of Nurses Strike in Minnesota, Affecting More Than a Dozen Hospitals
Thousands of nurses in Minnesota launched a three-day strike Monday over issues of pay and what they say is understaffing that has been worsened by the strains of the coronavirus pandemic.
The labor action includes 15,000 nurses and seven healthcare systems in the Minneapolis and Duluth areas. Those healthcare systems said they have recruited temporary nurses and are expected to maintain most services.
The nurses said they’ve been trying to negotiate higher wages under a new contract since March, but hospital executives have called their demands too expensive. Nurses were seeking more than 30% increases in compensation by the end of the three-year contract.
The Minnesota Nurses Association said that unless benefits are substantially improved, the continued loss of nurses will leave hospitals vulnerable. Nurses said they’re striking because hospitals refuse to hire more staff, a decision that means patients must endure long stints in the waiting room instead of receiving the care they need.
Axios-Ipsos Poll: Roll Credits on the Pandemic
Two and a half years into the pandemic, Americans say they’re doing well in most aspects of their lives — except possibly their personal finances, according to the latest installment of the Axios/Ipsos Coronavirus Index.
Why it matters: Many of us appear ready to roll the credits on the pandemic, despite lingering political divisions over the response and some residual distrust of government and some health institutions.
The public’s perception of personal risk also is at a low point, and people are starting to pick and choose more where they deem it necessary to take precautions like masking. Between the lines: While there haven’t been significant behavioral shifts since last spring, there’s been an across-the-board improvement in the public’s mood.
What they’re saying: “Most Americans have turned the page on the COVID pandemic, even as most acknowledge the virus is likely to be with us for the long term,” said Cliff Young, president of Ipsos U.S. Public Affairs.
WHO Report: 17 Million in EU May Have Suffered Long COVID
New research suggests at least 17 million people in the European Union may have experienced long COVID-19 symptoms during the first two years of the coronavirus pandemic, with women more likely than men to suffer from the condition, the World Health Organization said Tuesday.
The research, conducted for the WHO/Europe, was unclear on whether the symptoms that linger, recur or first appear at least one month after a coronavirus infection was more common in vaccinated or unvaccinated people. At least 17 million people met the WHO’s criteria of long COVID-19 — with symptoms lasting at least three months in 2020 and 2021, the report said.
The modeling also suggests that women are twice as likely as men to experience long COVID-19, and the risk increases dramatically among severe infections needing hospitalization, the report said. One-in-three women and one-in-five men are likely to develop long COVID-19, according to the report.
The research, which represents estimates and not actual numbers of affected people, tracks with some other recent studies on the constellation of longer-term symptoms after coronavirus infections.
As Demand for the Monkeypox Vaccine Stalls, Outreach Goes Hyperlocal
Federal health officials working to stem the monkeypox outbreak are shifting tactics in their immunization campaign as interest in the vaccine wanes and gaps in getting the shot to communities of color persist.
Earlier this summer, eager people snapped up vaccination appointments in cities from New York to Los Angeles. But a POLITICO review of a Biden administration pilot program that began last month to offer shots at large events found that supply outpaced demand, a trend mirrored nationwide as vaccine uptake has slowed.
Now the administration says it’s widening the net, creating another pilot to send vaccines to smaller venues and clinics.
More Reports of COVID Vaccine-Linked Heart Inflammation in Young Males Submitted to CDC + More
More Reports of COVID Vaccine-Linked Heart Inflammation in Young Males Submitted to CDC
The U.S. Centers for Disease Control and Prevention (CDC) recently released new data suggesting that cases of post-COVID-19 vaccine-linked heart inflammation among young males have risen.
Recent figures published in the CDC’s Vaccine Safety Datalink surveillance system show that within a week of getting the two-dose Pfizer-BioNTech vaccine, there were 14 confirmed cases of myocarditis or pericarditis among 102,091 males between the ages of 16 and 17. And of the 206,000 12- to 15-year-old males who got the same two-dose vaccine series, 31 cases were confirmed in a week, according to the data.
With last week’s report, the CDC said that the incident rate for the 12- to 15-year-old group is 150.5 per million — or about 1 in 6,600 — and 137.1 per million for the 16- to 17-year-old group — or about 1 in 7,262.
Following the first booster dose, CDC figures show that it jumps to 188 per million among the 16- to 17-year-old group. But for the 12- to 15-year-old males, 61.3 per million developed heart inflammation after the booster dose, according to the figures.
Cardiologist: Spike Proteins Generated by COVID Vaccines Are ‘Toxic’ to Heart
A pediatric cardiologist says that it’s now clear from all of the available evidence that the spike proteins the COVID-19 vaccines tell the body to make are toxic to the heart, and that myocarditis in young people is not as rare as the CDC and FDA have led Americans to believe.
In a lecture on Aug. 26, Dr. Kirk Milhoan said the harm to the heart caused by the spike proteins is an “inconvenient truth.”
Milhoan, a board-certified pediatric cardiologist, based his conclusion on data from the Vaccine Adverse Event Reporting System (VAERS) and several recently published studies on myocarditis. He believes that myocarditis caused by the COVID-19 vaccines is not as rare as the government has led Americans to believe.
In his Aug. 26 talk, Milhoan said the evidence shows that infection with SARS-CoV-2 likely results in the smallest exposure to the spike protein. In contrast, the mRNA vaccines cause the body to produce spike proteins for an unknown period, perhaps indefinitely.
Did the U.S. Jump the Gun With the New Omicron-Targeted Vaccines?
Last month, the FDA authorized Omicron-specific vaccines, accompanied by a breathless science-by-press release and a media blitz. Just days after the FDA’s move, the Centers for Disease Control and Prevention followed, recommending updated boosters for anyone age 12 and up who had received at least two doses of the original COVID vaccines. The message to a nation still struggling with the COVID-19 pandemic: The cavalry — in the form of a shot — is coming over the hill.
But for those familiar with the business tactics of the pharmaceutical industry, that exuberant messaging — combined with the lack of completed studies — has caused considerable heartburn and raised an array of unanswered concerns.
The updated shots easily clear the “safe and effective” bar for government authorization. But in the real world, are the Omicron-specific vaccines significantly more protective — and in what ways — than the original COVID vaccines so many have already taken?
If so, who would benefit most from the new shots? Since the federal government is purchasing these new vaccines — and many of the original, already purchased vaccines may never find their way into taxpayers’ arms — is the $3.2 billion price tag worth the unclear benefit? Especially when these funds had to be pulled from other COVID response efforts, like testing and treatment.
EU Stonewalls Over Von Der Leyen’s Role in Multibillion-Euro Pfizer Vaccine Deal
With every passing day, the negotiations held between the European Commission and Pfizer over the EU’s largest COVID-19 vaccine contract look less like business as usual and more like a whodunnit.
The plot thickened further after the European Court of Auditors published a report today, accusing the Commission of refusing to disclose any details of Commission President Ursula von der Leyen’s personal role in the talks.
The budget watchdog found that the EU chief threw out the existing rulebook to hash out a preliminary deal with the U.S. multinational, paving the way for a contract for up to 1.8 billion coronavirus vaccine doses to be signed in May 2021.
For all the other vaccine deals struck by the EU between 2020 and 2021, a joint team comprising officials from the Commission and seven member countries conducted exploratory talks. The outcome was then taken to a Vaccine Steering Board made up of representatives from all 27 EU member states who signed off on it.
The Mystery of Why Some People Don’t Get COVID
We all know a “COVID virgin,” or “Novid,” someone who has defied all logic in dodging the coronavirus. But beyond judicious caution, sheer luck or a lack of friends, could the secret to these people’s immunity be found nestled in their genes? And could it hold the key to fighting the virus?
In the early days of the pandemic, a small, tight-knit community of scientists from around the world set up an international consortium, called the COVID Human Genetic Effort, whose goal was to search for a genetic explanation as to why some people were becoming severely sick with COVID while others got off with a mild case of the sniffles.
After a while, the group noticed that some people weren’t getting infected at all — despite repeated and intense exposures. The most intriguing cases were the partners of people who became really ill and ended up in intensive care.
András Spaan, a clinical microbiologist at Rockefeller University in New York, was tasked with setting up an arm of the project to investigate these seemingly immune individuals. But they had to find a good number of them first. So the team put out a paper in Nature Immunology in which they outlined their endeavor, with a discreet final line mentioning that “subjects from all over the world are welcome.”
‘Guardrails’ Needed? Telehealth Fraud Cost Medicare $128 Million in First Year of COVID Pandemic, Feds Say
The federal government eased telehealth requirements at the beginning of the COVID-19 pandemic so more Americans could get remote care with fewer obstacles.
A report by government investigators last week found that more-permissive remote care has come at a price. During the first year of the pandemic, 1,714 doctors and health providers billed Medicare nearly $128 million in “high risk” claims, according to the Department of Health and Human Services Office of Inspector General.
The report comes less than two months after the inspector general’s office alerted medical professionals about rising telemedicine fraud by companies that often pay kickbacks to doctors, labs and others to generate orders paid by Medicare and other federal health programs.
Also in July, the Justice Department announced 36 people were charged with over $1 billion in health fraud involving telemedicine providers. Some were part of a telemarketing network that lured thousands of elderly or disabled patients to get unnecessary genetic testing or orders for medical equipment
St. Louis Research Fuels COVID Nasal Vaccine Rollout in India
St. Louis Post-Dispatch reported:
The science behind India’s new nasal vaccine for COVID-19 has its roots in St. Louis. India-based drug company Bharat Biotech announced last Tuesday that its nasal vaccine had received emergency approval. The vaccine technology was licensed by Washington University.
Dr. Michael Diamond, a Washington University professor and viral immunologist, said he began working on the vaccine in the spring of 2020 with fellow Washington University professor Dr. David Curiel. The world’s scientific community was just mobilizing on its massive, urgent search for methods to treat and prevent the new coronavirus.
Their work is now making its public debut nearly two years after the injectable products made by Pfizer, Moderna and others. But it could become a strong tool in the fight against COVID-19.
The new vaccine doesn’t require the ultra-cold storage needed for Pfizer’s shot. It is stored between 36 and 46 degrees Fahrenheit. And because it is administered through the nose, it doesn’t produce the biohazard waste of needles and syringes.
AstraZeneca Beats U.S. Shareholder Lawsuit Over COVID Vaccine Disclosures
AstraZeneca Plc (AZN.L) on Monday won the dismissal of a U.S. shareholder lawsuit claiming that the company failed to disclose problems in developing its COVID-19 vaccine, making it unlikely to win regulatory approval to market the vaccine in the United States.
U.S. District Judge Paul Oetken in Manhattan said AstraZeneca shareholders in the proposed class action failed to identify any misleading statements, or adequately allege that the company intended to defraud them.
Oetken dismissed the lawsuit with prejudice, meaning it cannot be brought again.
EU Regulator Backs Pfizer’s BA.4/5-Adapted COVID Booster
The European Medicines Agency (EMA) on Monday recommended a COVID-19 booster designed to combat Omicron offshoots BA.4/5, days after endorsing a pair of boosters tailored to target the older BA.1 variant.
The latest recommendation is for a so-called bivalent vaccine developed by Pfizer (PFE.N) and BioNTech (22UAy.DE), which targets BA.4/5 as well as the strain of the virus that originally emerged in China in December 2019.
The EMA recommendation is to authorize the vaccines for people aged 12 and above who have received at least primary vaccination against COVID. The final go-ahead will be subject to European Commission approval, which is expected to come in shortly.
