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FDA official, without providing data, claims link between COVID-19 vaccines and pediatric deaths

By
Kerry Breen
News Editor
Kerry Breen is a news editor at CBSNews.com. A graduate of New York University's Arthur L. Carter School of Journalism, she previously worked at NBC News' TODAY Digital. She covers current events, breaking news and issues including substance use.
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Kerry Breen,
Margaret 91³Ô¹ÏÍø
Margaret 91³Ô¹ÏÍø
Moderator, "Face the Nation with Margaret 91³Ô¹ÏÍø;" Chief foreign affairs correspondent
Margaret 91³Ô¹ÏÍø is moderator of "Face the Nation with Margaret 91³Ô¹ÏÍø" on CBS. Based in Washington, D.C., 91³Ô¹ÏÍø is also the Network's chief foreign affairs correspondent and a contributing correspondent to 60 Minutes. Additionally, she appears regularly on the "CBS Evening News," leading coverage from Washington when news breaks on the political and foreign affairs fronts.
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Margaret 91³Ô¹ÏÍø,
Dr. Céline Gounder
Dr. Céline Gounder
Medical Correspondent
Dr. Céline Gounder, an internist, epidemiologist and infectious disease specialist, is a CBS News medical correspondent as well as senior fellow and editor-at-large for public health at KFF Health News.
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Dr. Céline Gounder

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Dr. Vinay Prasad, the director of the Food and Drug Administration's vaccine division, sent a memo to staff that linked children's deaths to the COVID-19 vaccine, but did not provide data to back the claim. 

The memo said that a review "found that at least 10 children have died after and because of receiving COVID-19 vaccination," according to multiple sources familiar with the email. The memo was first reported by the New York Times.  

Prasad suggested that the deaths were related to myocarditis, or the inflammation of the heart muscle. Prasad did not share any data used in the review, including the children's ages, whether they had existing health conditions, or how the FDA determined there was a link between their death and the vaccine. The findings were not published in a peer-reviewed medical journal.

Myocarditis has been linked to the COVID-19 vaccine, but that the risk of the condition is significantly higher after a coronavirus infection, pediatric cardiologists told CBS News in 2023. The prognosis following myocarditis due to the vaccine is also better than from infection, . COVID-19 infection is also linked to other long-term complications.

The risk of myocarditis appears to be higher when vaccine doses are given closer together, as was the case when the vaccines first hit the market. Now, most people receive each dose of the vaccine about a year apart. If someone receives the primary series before age 5, the risk virtually disappears. 

Pfizer and Moderna COVID-19 vaccines carry warnings about the risk of myocarditis or pericarditis, a condition where the membrane surrounding the heart becomes inflamed. The warnings were expanded in April 2025 to apply to males aged 16 to 25. The rate of myocarditis and pericarditis was around 8 cases per million doses for children and adults under 65 years old after use of that season's vaccines, the FDA said at the time.

COVID-19 vaccines, developed during the first Trump administration, have become a target of the second. Top FDA officials selected by the administration under Health and Human Services Secretary Robert F. Kennedy Jr. overrode career staff to limit the approvals of COVID-19 shots from Novavax and Moderna, according to records released by the FDA. A Centers for Disease Control and Prevention official said in June that she was resigning from her role overseeing updates to the agency's COVID-19 vaccine recommendations, following an order from Kennedy that forced an update to the agency's guidance. 

Changing COVID-19 vaccination guidance has caused confusion for many. The CDC's vaccine advisory committee, known as the Advisory Committee on Immunization Practices, or ACIP, voted in September to change recommendations for the shot. All members of the committee have been picked by Kennedy, himself a vaccine skeptic. Several of the panel members have criticized the COVID-19 vaccine. 

The updated CDC guidance recommends people make individual, informed decisions about COVID-19 vaccination, but did not specifically recommend the shots. The American Academy of Pediatrics said it was "strongly recommending" shots for children between 6 months and 2 years old, while the  recommended the vaccine for everyone six months and older. State governments have also banded together, forming the  and the , to issue recommendations that differ from the CDC guidance. 

Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, told CBS News in August that there's "a lot of noise out there" when it comes to vaccines, but advises parents to "stick the course" and talk to your doctor about making sure children get all their necessary vaccinations, including the initial COVID vaccination series. 

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