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A newly surfaced internal memo from the U.S. Food and Drug Administration (FDA) has sparked debate after chief medical and scientific officer Vinay Prasad stated that COVID-19 vaccinations may have contributed to at least 10 cases of fatal heart inflammation in children. According to the memo, seen by Reuters, Prasad said the staff’s preliminary review suggested “likely, probable, or possible” vaccine attribution in these deaths. He described the findings as significant, noting it would mark the first time the FDA acknowledged potential fatal vaccine-related cases in American children.
The analysis reviewed 96 child deaths reported between 2021 and 2024. While it did not identify the children’s underlying medical conditions or the vaccine manufacturers involved, Prasad said that the early assessment found no fewer than 10 cases potentially linked to COVID-19 vaccination. He added that examining deaths involving children aged 7 to 16 was especially difficult.
Health Secretary Robert F. Kennedy Jr. has recently shifted U.S. vaccine policy, restricting access to COVID-19 vaccines to individuals 65 and older and those with certain conditions. Kennedy, long known for his skepticism toward vaccines, has criticized past vaccine policies promoted under both the Trump and Biden administrations.
Experts have urged caution in interpreting the memo. The FDA’s assessment has not been peer-reviewed or published in a medical journal, and critics—including UC Law San Francisco professor Dorit Reiss—argue that policy changes should not stem from unpublished investigations. Reiss also noted Prasad is not a vaccine specialist.
Despite concerns raised in the memo, FDA Commissioner Marty Makary emphasized that COVID-19 vaccines were highly effective for older adults, especially when matched to circulating variants. Recent research also supports the benefits of updated vaccines in reducing severe illness and hospitalization among high-risk groups.
CDC data shows 1,071 U.S. children aged 5 to 18 died from COVID-19 between early 2020 and mid-2023. Prasad argued that it remains unclear how vaccination influenced those outcomes, stating that voluntary reporting and unknown prevention metrics complicate comparisons.
The memo is expected to fuel continued discussion ahead of an upcoming CDC vaccine committee meeting.
