The Food and Drug Administration advisory committee recently rejected a proposal to distribute booster shots of Pfizer and BioNTech’s Covid-19 vaccine to the general public.
The proposal follows a recommendation by the Biden administration for booster shots every 5 months and comes as both Pfizer and Moderna say that the ‘immunity’ provided by their vaccines wanes over time.
The committee voted 16-2 against distributing the vaccines to the general American population aged 16 and older, but unanimously embraced an alternate plan to give boosters to older Americans.
Chief medical adviser, Dr Anthony Fauci, still believes though that the FDA will recommend and allow the mass booster campaign to the general population, possibly after the winter.
“The story is not over because more and more data is coming in and will be coming in,” Fauci said Sunday on ABC’s “This Week.”
U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky recently also endorsed the Pfizer booster shot for younger at-risk workers, which is reported to be ‘a rare break’ from the agency’s Advisory Committee on Immunization Practices panel.
Walensky put it back in, saying it aligns with a U.S. Food and Drug Administration booster authorization from earlier this week.
Last month, Biden said a broad booster plan would begin immediately before the FDA’s vaccine advisory panel voted overwhelmingly against the recommendation.
During the FDA’s hearing on the approval of booster shots, several doctors spoke out about some of the risks.
Dr Rose, a doctor who attended the FDA hearing, stated that based on the Vaccine Adverse Event data (VAERS Data) the risks far outweigh the benefits, especially for children.
Dr. James Hildreth, a voting member on the FDA expert panel, said that he has “a serious concern of myocarditis in young people.” Another expert, Dr. Melinda Wharton, said she does “not feel comfortable” with recommending boosters to younger people due to the risk of myocarditis.
Fauci’s view was shared by the head of the U.S. National Institutes of Health, Francis Collins, who said he also believes COVID-19 vaccine booster doses will be expanded despite the FDA panel experts recommending against them for the general population.
In an interview on Sunday morning, Collins said that the booster doses will be approved in the future.
“I think the big news is that they actually did approve the initiation of boosters, and remember they’re taking a snapshot of right now. We’re going to see what happens in the coming weeks,” Collins told news outlets. “It would surprise me if it does not become clear over the next few weeks, that administration of boosters may need to be enlarged.”
According to an ABC news report, the recent vote on the rollout of boosters may be inconsequential. According to the report, potentially millions of Americans have already received unauthorized booster shots on their own.
Based on an internal briefing document reviewed by ABC News, the CDC estimates that about 1.1 million Americans already received the extra shot. This number is likely is an undercount because it ignores people who may have received the one-shot Johnson & Johnson vaccine and got another shot.
Weeks prior to the FDA vote on boosters, the US Food and Drug Administration announced the resignations of two top vaccine officials, and reports said the two were leaving in anger over the Biden administration’s plan to roll out COVID-19 booster shots before officials had a chance to approve it.
Dr. Marion Gruber, the director of the FDA’s Office of Vaccines Research and Review, and Dr. Philip Krause are planning on leaving the FDA in October and November.
According to Business Insider, one former senior FDA leader said that Gruber and Krause were leaving because they felt that the CDC was making vaccine decisions that should have been left to the FDA.
The report said the ‘final straw’ was the Biden administration announcing the rollout of the booster-shot plan before the FDA had officially signed off on it.
According to the New York Post, immediately following the FDA decision, Pfizer announced their proprietary vaccine has been found to be ‘safe and effective in children aged 5 to 11.
Pfizer now plans to use the data from the clinical trial to seek authorization from the US Food and Drug Administration and other health regulators for the 5 to 11 age group “as soon as possible”.
According to reports, school districts across the country are already mandating COVID-19 vaccines for students 12 and up in order to return to class after the winter break.
Students in the Los Angeles school district will have to have their second dose of the vaccine by Halloween.
According to a new study published in MedRxiv, the current COVID vaccines could potentially be more dangerous to Children than COVID-19 itself.
The study found that after healthy male children received their COVID-19 vaccine, CDC-defined myopericarditis rates were many times higher than their hospitalization rates for the same demographic during moderate to high transmission periods.
According to the data, the vaccines are statistically at least 6 times more likely to cause heart problems than a child’s risk to be hospitalized from Covid-19.
The rate of hospitalization for children aged 5-17 stands at approximately 6 per 100,000 for COVID-19, whereas the estimated rate of hospitalization for influenza is much higher in the same age group.
Additionally, according to a study out of Stanford University, COVID-19 hospitalizations among children are immensely over-counted.
Furthermore, a team of Johns Hopkins researchers recently reported that after studying a large sample size of children, they found zero COVID deaths among healthy kids.
Dr. Marty Makary, a medical expert and professor at the Johns Hopkins School of Medicine, analyzed approximately 48,000 children under 18 diagnosed with Covid from April to August 2020. Makary and his team “found a mortality rate of zero among children without a pre-existing medical condition such as leukemia.”