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Investing.com -- Shares in major COVID-19 vaccine makers fell on Monday after an internal U.S. Food and Drug Administration (FDA) memo reportedly suggested that vaccinations may have contributed to several child deaths linked to heart inflammation.
Shares in Moderna dipped 3.4% in premarket trading, and Novavax slipped 1.1% by 07:05 GMT. Pfizer stock was down 0.3%.
In the document seen by Reuters, FDA chief medical and scientific officer Vinay Prasad told agency staff that “no fewer than 10” of 96 pediatric deaths reviewed between 2021 and 2024 were probably connected to COVID-19 shots.
“These deaths are related to vaccination (likely/probable/possible attribution made by staff),” Prasad reportedly wrote in the memo.
“This is a profound revelation. For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children.”
The memo said the cases involved children between seven and 16 years old but did not detail their medical histories or specify the manufacturers. Prasad described the findings as difficult to read and outlined plans to strengthen oversight of vaccines.
The review comes as Health Secretary Robert F. Kennedy Jr. sharply restricts access to COVID-19 vaccines to people 65 and older and those with certain health conditions.
Kennedy, a longtime vaccine critic before joining President Donald Trump’s administration, has sought to overhaul national immunization policies.
Federal health officials under both Trump and Joe Biden had strongly backed the vaccines as essential to saving lives when they were rolled out in 2020.
Prasad, who returned to his FDA leadership post in September after previously criticizing vaccine and mask mandates, now advises senior agency officials on emerging scientific issues.
The New York Times reported that the FDA’s findings have not undergone peer review and that the U.S. Centers for Disease Control and Prevention’s vaccine advisory committee is set to meet next week.
CDC data shows 1,071 people aged five to 18 died of COVID-19 between January 2020 and June 2023. In the memo, Prasad cautioned against drawing broad comparisons.
“Comparing the number of kids who died from COVID against these (vaccine-related) deaths would be a flawed comparison,” he wrote.
“We do not know how many fewer kids would have died had they been vaccinated, and we do not know how many more kids died from taking vaccines than has been voluntarily reported.”
Meanwhile, the vaccines performed well for older Americans, FDA Commissioner Marty Makary said in a TV interview over the weekend.