In an article published Wednesday in The New England Journal of Medicine, 12 former Food and Drug Administration commissioners sharply criticized anticipated changes to vaccine policy that were detailed in a leaked memo from an agency official.
“We are deeply concerned by sweeping new F.D.A. assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective and available when the public needs them most,” the former commissioners wrote.
The former commissioners, including four from the first Trump administration, were responding to a memo written by Dr. Vinay Prasad, the director of the F.D.A.’s vaccine division. He sent it to agency staff members on Friday, outlining findings from a review of reports concerning 10 childhood deaths and attributing them to myocarditis, or inflammation of the heart muscle, after receiving a Covid-19 shot.
The memo was obtained by The New York Times and not publicly released. It did not provide details such as the ages of the children, whether they had any health problems or how the agency had determined the vaccine-death link. Nor did it disclose the makers of the vaccines involved.
In the memo, Dr. Prasad said he would propose new oversight and a review of vaccines, though it was unclear whether the White House had been advised of the memo’s contents. The proposals could be refined by government officials or challenged by lawmakers and drug companies.
Among the changes Dr. Prasad outlined for oversight and approval were requirements that studies looking at people using a vaccine or a placebo include all subgroups, such as pregnant women. He said the annual practice of updating flu vaccines to match a circulating strain would be re-examined. Companies also would need to do larger studies before promoting vaccines as safe to administer together, such as the flu and Covid-19 vaccines, according to the memo.
The Department of Health and Human Services, which oversees the F.D.A., did not immediately respond to a request for comment. Dr. Prasad also did not immediately respond to a request for comment.
The department is overseen by Robert F. Kennedy Jr., who has repeatedly criticized the Covid shots as deadly despite the scientific consensus that they are safe. Mr. Kennedy has said there is no scientific evidence that vaccines don’t cause autism.
The former commissioners, who served in each presidency dating back to George H.W. Bush’s administration, wrote that the proposals in Dr. Prasad’s memo would “undermine the public interest” and “upend core policies governing vaccine development and updates.”
“The memo 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,” the commissioners wrote.
The 10 deaths mentioned by Dr. Prasad had previously been investigated by F.D.A. staff members who reached different conclusions, the commissioners wrote. Additionally, “substantial evidence” shows vaccines reduce the risk of severe disease and hospitalization in children, the commissioners wrote.
The people the F.D.A. aims to protect, such as those at high risk from serious infections, would be harmed by not updating vaccines against current strains of viruses, such as the flu virus, they wrote: “Because these viruses change frequently, repeating large-scale efficacy trials for every new seasonal strain is not feasible within the time needed to update the vaccines.”
If the current methods are changed, there will be a higher and more subjective bar for vaccine approval, the commissioners wrote. It would also be more costly for companies to win approval for their vaccines.
Additionally, the commissioners criticized the administration’s unchecked changes.
“Changes of this magnitude should be developed by guidance or regulation, with broad consultation within the agency, meaningful opportunity for public comment and often public advisory-committee input,” the former commissioners wrote.
In the memo, Dr. Prasad criticized F.D.A. employees who did not agree with him, telling them to resign, the commissioners wrote.
“Americans’ safety depends on a culture in which evidence is reviewed openly and staff can surface concerns, challenge leadership and engage with external scientists without fear of reprisal,” they wrote.
Rylee Kirk reports on breaking news, trending topics and major developing stories for The Times.
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