US FDA director claims at least 10 kids died ‘after and because of’ receiving COVID vaccine: Report

Dr Prasad's FDA memo reveals potential links between COVID vaccines and child deaths. He outlined updates to vaccine oversight and approval in his memo, stating that randomised studies would now need to include all subgroups, including pregnant women.

Garvit Bhirani
Updated29 Nov 2025, 01:30 PM IST
US FDA director claims at least 10 kids died 'because of’ COVID vaccine: Report (File photo)
US FDA director claims at least 10 kids died 'because of’ COVID vaccine: Report (File photo)

In a memo to FDA staff on Friday, Dr Vinay Prasad, director of the agency’s vaccine division, stated that a review had identified at least 10 children who died “after and because of” receiving a Covid vaccine. He indicated that the deaths may have been linked to myocarditis, an inflammation of the heart muscle, according to The New York Times.

“This is a profound revelation. For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children," NYT quoted Dr Prasad, an oncologist who was a vocal critic of US COVID vaccine and mask mandates, as saying. He returned to his position as the FDA’s chief medical and scientific officer in September.

The memo, obtained by NYT but not publicly released, did not provide details such as the children’s ages, any underlying health conditions, the method used to determine the vaccine-death connection, or the vaccine manufacturers involved.

Dr. Prasad outlined updates to vaccine oversight and approval in his memo, stating that randomised studies would now need to include all subgroups, including pregnant women. He also criticised the annual process for selecting the flu vaccine as a “catastrophe of low-quality evidence” and indicated that it would be reviewed as well.

Health Secretary Robert F. Kennedy Jr. has significantly altered US COVID vaccine policy, restricting their availability to people aged 65 and older and those with underlying health conditions.

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Kennedy, who previously campaigned against vaccines before becoming the nation’s top health official under President Donald Trump, has also suggested a link between vaccines and autism and attempted to revise the country’s immunisation policies. During Trump’s first term and continuing under Joe Biden, US health authorities had vigorously promoted COVID vaccines as lifesaving.

Vaccine expert at Children’s Hospital of Philadelphia disagrees with memo

Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and a critic of Robert F. Kennedy Jr.’s vaccine policies, described the memo as an example of science “by press release". He noted that the memo lacked important context, such as the number or rate of deaths from COVID-19 itself among vaccinated and unvaccinated children.

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Dr. Offit explained that children who developed vaccine-related myocarditis were treated at the hospital and generally recovered quickly. “On the other hand, we saw children admitted to our hospital with myocarditis from the virus. It was quite severe and caused admissions to the intensive care unit, he stated.

According to The New York Times, the results of the recent FDA review have not yet been published in a peer-reviewed medical journal. The report also noted that the CDC’s vaccine committee is scheduled to meet next week.

Meanwhile, Michael Osterholm, an infectious disease expert at the University of Minnesota and a critic of Mr. Kennedy’s oversight of the health agency, said he believes the memo was deliberately released ahead of the meeting. “This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events,” he stated.

Key Takeaways
  • At least 10 children died 'after and because of' receiving the COVID vaccine, according to US FDA director's memo, says report.
  • He indicated that the deaths may have been linked to myocarditis, an inflammation of the heart muscle, the NYT report noted.
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