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- A new FDA memo linked 10 child deaths to COVID vaccines.
- Health Secretary Robert F. Kennedy Jr. has already limited COVID vaccines to those over 65 and high-risk groups.
- The CDC's vaccine committee will meet; the FDA review lacks peer-reviewed publication.
WASHINGTON — COVID-19 vaccinations probably contributed to the deaths of at least 10 children who died of heart inflammation, Food and Drug Administration chief medical and scientific officer Vinay Prasad told agency staffers.
"These deaths are related to vaccination (likely/probable/possible attribution made by staff)," Prasad wrote in a Friday memo seen by Reuters. "This is a profound revelation. For the first time, the FDA will acknowledge that COVID-19 vaccines have killed American children."
Health Secretary Robert F. Kennedy Jr. has sharply changed government policy on COVID vaccines, limiting access to them to people 65 and older, as well as those with underlying conditions. Kennedy, a longtime anti-vaccine crusader before taking on the nation's top health post under President Donald Trump, has also linked vaccines to autism and sought to rewrite the country's immunization policies.
During Trump's first term, when the pandemic erupted, and subsequently under his successor Joe Biden, health officials strongly endorsed the vaccines as lifesaving. The COVID-19 vaccines were released in 2020.
The memo did not disclose the health conditions of the children, or the vaccine manufacturers involved. The findings were based on an initial analysis of 96 deaths between 2021 and 2024, which Prasad said "concludes that no fewer than 10 are related" to COVID-19 vaccinations.
"It is difficult to read cases where kids aged 7 to 16 may be dead as a result of COVID vaccines," Prasad wrote in the memo.
He announced plans to tighten vaccine oversight.
FDA review has not been peer-reviewed
The findings of the new FDA review have not been published in a peer-reviewed medical journal, The New York Times reported earlier, adding that the Centers for Disease Control and Prevention's vaccine committee is to meet next week.
Dorit Reiss, professor of law at UC Law San Francisco, who has written on vaccines and law, criticized Prasad for suggesting changes to the approval for respiratory vaccines based on the conclusion of an unpublished investigation by what she said were unknown people.
"It is more problematic given that Dr Prasad's expertise is not in vaccines, but it would be problematic even if he were a vaccine expert," Reiss posted on X.
Prasad, an oncologist who was an outspoken critic of COVID vaccine and mask mandates, regained his role as the FDA's chief medical and scientific officer in September.
He advises the FDA commissioner and other senior officials on emerging medical and scientific issues impacting regulatory science and public health.
CDC data indicates that 1,071 people aged 5 to 18 died of COVID-19 from Jan. 4, 2020, to June 24, 2023. Although vaccine experts generally have praised COVID-19 vaccinations as effective, Friday's memo from Prasad argued there was no way of knowing whether the benefit outweighed the risk.
"Comparing the number of kids who died from COVID against these (vaccine-related) deaths would be a flawed comparison," Prasad 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."
While Friday's memo focused on children's deaths during the pandemic, FDA Commissioner Marty Makary said during a Saturday TV interview that the COVID-19 vaccine worked well for older recipients.
"The COVID shot was amazing for people at risk and for older people, especially when it was a good match for the circulating virus," Makary told Fox News' "Fox and Friends" show.
A study published last month found that updated versions of the vaccine helped prevent severe outcomes, such as hospitalizations and death, among veterans.
