Twelve former US FDA commissioners express deep concern about agency’s vaccine change
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The US Food and Drug Administration is planning changes to regulation of vaccines including annual flu shots.
PHOTO: REUTERS
NEW YORK – Twelve former US Food and Drug Administration (FDA) commissioners said on Dec 3 they were deeply concerned about proposed changes to vaccine regulation by the agency’s chief scientific officer and the details of his assertion that the Covid-19 vaccine killed 10 children.
The commissioners were responding to an e-mail sent last week by Dr Vinay Prasad, FDA’s chief medical and scientific officer, in which he told agency staffers that Covid-19 vaccinations probably contributed to the deaths of at least 10 children who died of heart inflammation, but provided few details on how the analysis of those cases was performed.
Dr Prasad also outlined planned changes to regulation of vaccines, including annual flu shots, saying that companies must prove that vaccines work through randomised trials rather than ones that demonstrate the shots elicit an immune response.
“The proposed guidelines would dramatically change vaccine regulation on the basis of a reinterpretation of selective evidence and by a process that breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity,” the former FDA commissioners, who served under both Republican and Democratic presidents, wrote in a piece published in the New England Journal of Medicine.
The authors include Dr Scott Gottlieb and Dr Brett Giroir, who served as commissioners during US President Donald Trump’s first term.
“The fact these criticisms are coming from former FDA officials who opposed raising the bar for vaccine science confirms we are on the right track,” HHS spokesman Andrew Nixon said in an e-mailed statement.
Dr Prasad did not immediately respond to a request for comment.
Dr Prasad’s memo, the commissioners wrote, “offered no explanation of the process and analyses that were used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation”.
Dr Prasad was hired by Health Secretary Robert F. Kennedy Jr, a long-time anti-vaccine activist, who has been working to remake US vaccine policy and has called for placebo-based trials of vaccines in the past. Many scientists say it is not typically possible to run such trials for ethical reasons. REUTERS
