Image Credit: Joe Raedle / Staff / Getty Images The Food and Drug Administration is now officially attributing the deaths of ten children to the Covid vaccines.
The deaths were the subject of a memo circulated among agency staff after an internal investigation ten children’s deaths to myocarditis suffered “after and because of” getting a Covid vaccine.
The memo, obtained by The New York Times, did not provide any further details about the children such as their age or health status at time of vaccination. The memo also did not disclose which vaccines the children were given.
“This is a profound revelation,” Dr. Vinay Prasad, director of the FDA’s vaccine division, wrote in the memo.
“For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”
The recognition marks a sharp about-turn on FDA policy. Health officials in the first Trump administration and under President Biden strongly endorsed the vaccines.
Under the tenure of new health secretary Robert F. Kennedy Jr., Covid-vaccine policies have been altered to limit access to people aged 65 and over and younger people with underlying medical conditions.
The FDA memo also announced changes to vaccine oversight and approval. There will now be a requirement for randomized studies to include all subgroups, including pregnant women. Dr Prasad also said the annual framework for choosing the flu vaccine would be re-examined.
The CDC’s vaccine committee is due to meet next week to discuss the broader childhood vaccination schedule.
It plans to review the hepatitis B vaccine, which Secretary Kennedy has said is unnecessary for newborns.