A confidential memo from the US Food and Drug Administration has raised new questions about the safety of COVID-19 vaccines for children. According to a report in The New York Times, the memo says at least 10 children in the United States likely died “because of” COVID-19 vaccination. The memo points to myocarditis, a form of heart inflammation, as a possible reason.
The memo was written by Vinay Prasad, the FDA’s chief medical and scientific officer. The New York Times reported that the document does not give the ages of the children, their medical backgrounds or which vaccine makers were involved. The memo also does not explain the method used to link the deaths to the vaccines.
Prasad called the finding “a profound revelation,” according to the New York Times. He said the FDA will now tighten rules for vaccine approval, including requiring randomized studies for all major groups, such as pregnant women. Prasad also wrote that the yearly process used to choose the flu vaccine needs review, calling the current system weak and based on low-quality evidence.
Health department declines to comment
The Department of Health and Human Services did not respond to Reuters’ request for comment on the report. The memo has come at a sensitive time as national policies on vaccines are being changed.
Kennedy’s new vaccine policy
Health Secretary Robert F. Kennedy Jr., a longtime critic of vaccines, has sharply limited access to COVID-19 shots. Under his new rules, the vaccines are now available only to people aged 65 and older or those with serious health conditions.
Kennedy has previously linked vaccines to autism and has pushed for changes to the national immunization schedule. His new policies mark a clear shift from the stance taken by officials during the Trump and Biden administrations, when COVID-19 vaccines were strongly promoted as essential and lifesaving.
Details missing from the memo
The New York Times reported that the findings in the memo have not been published in a peer-reviewed medical journal. No detailed data has been released. This means many questions remain unanswered, including how the FDA determined the link between vaccination and the 10 child deaths.
Prasad, who returned to his FDA role in September, had earlier been a critic of COVID-19 vaccine mandates and mask rules. He currently advises the FDA commissioner on medical and scientific policy.
Experts question the memo
Some health experts have raised concerns about the lack of information in the memo. Dr. Paul Offit, a vaccine specialist at the Children’s Hospital of Philadelphia and a critic of Kennedy’s vaccine policies, told the New York Times that the memo represents “science by press release.”
Offit said the memo does not give important context, such as how many children died from COVID-19 itself or how vaccination changed the risks. He explained that children who developed myocarditis after vaccination were usually treated and recovered quickly. In contrast, he said myocarditis caused by the virus was often more severe and required intensive care. “We saw children admitted to the ICU with myocarditis from the virus,” he told the New York Times.
CDC committee will review data
The New York Times also reported that the CDC’s vaccine committee is scheduled to meet next week to discuss the latest information. Some experts believe the memo was shared just before the meeting to influence the discussion.
Michael Osterholm, an infectious-disease expert at the University of Minnesota and a critic of Kennedy’s oversight of the health agency, said the memo’s release was irresponsible. “This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events,” he said.
The FDA has not commented publicly on the memo. It is unclear whether more details will be released about the 10 child deaths mentioned in the document.
For now, the memo has added new debate over vaccine safety and how the government communicates risks to the public. More clarity is expected at the upcoming CDC meeting.
Disclaimer: The story is based on a report by the New York Times. Financial Express.com could not independently verify it.
