Vinay Prasad, the head of the US FDA’s Center for Biologics Evaluations and Research which oversees vaccines, said that future vaccine approvals will face stricter standards in light of the deaths of children after they received the COVID-19 shot.
In an email to CBER staff obtained by The Washington Post, Prasad said that at least 10 children died “after and because of receiving COVID-19 vaccination,” adding that the deaths “are related to vaccination.”
Prasad cited data from the agency’s Vaccine Adverse Event Reporting System that indicated that young and healthy men and boys who were the least likely to have COVID complications had a higher risk of vaccine-induced myocarditis, a serious inflammation of the heart muscle.
In June, the FDA mandated that mRNA-based COVID vaccines form Moderna (MRNA) and Pfizer (PFE) update their labeling about an increased risk of myocarditis and pericarditis following vaccination. Though not an mRNA shot, Novavax’s (NVAX) COVID jab also contains the warning.
In a July JAMA article, Prasad and FDA Commissioner Marty Makary noted that the “estimated unadjusted incidence of myocarditis and/or pericarditis was approximately 27 cases per 1,000,000 (or 1 in 37 000) in males aged 12 to 24 years for the 2023 to 2024 formula of mRNA COVID-19 vaccines.”
“FDA has never requested the manufacturers demonstrate in randomized fashion that vaccinating children improves” COVID outcomes, Prasad wrote in the email, adding, “We do not know how many fewer kids would have died had they been vaccinated, and we do not know how many more kids died from taking vaccines than has been voluntarily reported….it is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved.”
As a result, Prasad unveiled a new “path forward” centered on “evidence based medicine” that includes denying approval for vaccines in pregnant women “based on unproven surrogate endpoints”; pneumonia vaccines will need to demonstrate a reduction in pneumonia rather than just generating antibody titers; and immunogenicity can’t be used to expand a vaccine’s indicated population — these groups will need to be included in trials during development.
He added that annual flu vaccines approvals will be revised, as the current system “is an evidence-based catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.”
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