|Former F.D.A. Commissioners Sound Alarm on Plan to Change Vaccine Policy
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.
|Former F.D.A. Commissioners Sound Alarm on Plan to Change Vaccine Policy
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.](https://www.nejm.org/doi/full/10.1056/NEJMp2517497?query=featured_home)
The former commissioners, including four from the first Trump administration, were responding to a memo written by [Dr. Vinay Prasad](https://www.nytimes.com/2025/08/09/us/politics/fda-vaccine-chief-returns.html), 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](https://www.nytimes.com/2025/11/28/health/fda-children-deaths-covid-vaccines.html?searchResultPosition=1) 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.