FDA to investigate whether adult deaths linked to coronavirus vaccine
The Food and Drug Administration is investigating whether coronavirus vaccines are linked to deaths of adults, part of an investigation that has alleged children died as a result of the shots, federal health officials said Tuesday.
“FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to coronavirus vaccines,” said Andrew Nixon, a spokesman for the Department of Health and Human Services.
The agency also is reviewing safety of immunizations for RSV, according to manufacturers of the therapies who have been contacted by the FDA, a move first reported by Reuters.
The Washington Post reported late last month that the nation’s top vaccine regulator said the agency found “at least 10 children have died after and because of receiving COVID-19 vaccination,” without citing specific evidence. Public health experts have called on the agency to release more details on how it performed its review and on the planned changes to vaccine regulation. Previous studies have shown the coronavirus vaccines have a generally safe track record.
The senior official, Vinay Prasad — who directs the FDA division that approves vaccines — wrote in a leaked internal email last month that the agency would set a higher bar for approving vaccines and require some to demonstrate they protect patients from diseases, at least after they become available on the market, rather than simply generating antibodies that fight the infections.
News that the investigation is also examining potential adult deaths was first reported by Bloomberg.
The prospect of major changes to how vaccines are approved alarmed many in the public health community, who questioned the evidence for tying children’s deaths to the vaccines. The coronavirus vaccines, like virtually all medicines, have side effects listed in their prescribing labels. Under the leadership of Health Secretary Robert F. Kennedy Jr., who founded a prominent anti-vaccine group, HHS has issued negative pronouncements suggesting that the use of mRNA-based coronavirus vaccines is risky.
Some financial analysts said it isn’t clear that the more rigorous review policy described in Prasad’s email will go into effect, noting that it wasn’t formally announced. The email, which HHS has defended, was not cleared with Kennedy or the health department, and Prasad did not discuss it with the secretary, before it was sent in late November, The Post previously reported.
Nixon previously said health officials “will soon release documents laying out that framework and data confirming how the coronavirus vaccine resulted in children’s deaths that previous leadership failed to properly investigate.”
Prasad’s plans, as outlined in his email, would reshape the FDA’s process for approving vaccines and likely require pharmaceutical companies to run larger studies, vaccine experts said, which could add to the burden of developing novel vaccines. A dozen former FDA commissioners argued last week in a New England Journal of Medicine article that the efforts could undermine the nation’s ability to fight infectious diseases and could threaten the health of vulnerable Americans.
Separately, the FDA has reached out to some drugmakers with concerns about the safety of preventive treatments for respiratory syncytial virus, RSV. Merck confirmed that it met briefly with FDA officials last week regarding Enflonsia, its monoclonal antibody to prevent RSV in infants.
“We expect questions from the FDA, and we want them to ask,” Merck said in a statement Tuesday, adding that it is “confident in the safety profile of Enflonsia.”
Reuters earlier reported that U.S. health regulators had approached Merck, Sanofi and AstraZeneca about the safety of their RSV therapeutics.
Sanofi, which developed its RSV therapeutic Beyfortus with AstraZeneca, said in a statement that its safety and effectiveness have been proven in clinical trials and studies involving more than 400,00 infants, and that “no safety issue has been identified.”