The revelation has led to major changes in federal vaccine policy and renewed questions about how the shots were approved.
The Friday memo, written by FDA chief medical and scientific officer Vinay Prasad and obtained by Reuters, said the agency’s initial review of 96 pediatric deaths between 2021 and 2024 found that “no fewer than 10 are related” to COVID-19 vaccination. Prasad told staff that the attribution was categorized as “likely, probable, or possible” by FDA reviewers.
Prasad wrote that the agency is now acknowledging for the first time that COVID-19 vaccines “have killed American children.” He described the findings as “a profound revelation.” His memo said the cases involved children aged 7 to 16 who died from heart inflammation.
The memo did not identify the children’s medical histories or the vaccine manufacturers. Prasad said the analysis is ongoing and that the FDA will move to tighten vaccine oversight. He noted that it is difficult to review cases where minors who appeared healthy died shortly after vaccination.
The findings have not been published in a peer-reviewed journal. The New York Times reported that the Centers for Disease Control and Prevention’s vaccine committee is scheduled to meet next week to discuss the issue.
The FDA’s renewed stance aligns with broader policy changes under Health Secretary Robert F. Kennedy Jr., who has limited access to COVID-19 vaccines to people 65 and older and those with underlying conditions. Routine vaccination is no longer recommended for healthy children or pregnant women.
According to CDC data, 1,071 Americans between ages five and eighteen died from COVID-19 between January 2020 and June 2023. Prasad argued that comparing COVID deaths to vaccine related cases is misleading. He said it is unknown how many children would have died without vaccination and how many deaths linked to the shots have gone unreported.
Some experts are pushing back. Dorit Reiss, a law professor at UC Law San Francisco who studies vaccine law, said it is improper to propose major changes based on an unpublished investigation conducted by unnamed staff. She also questioned Prasad’s qualifications, noting that his background is oncology and not vaccine development.
Prasad returned to his FDA leadership post in September after previously criticizing vaccine mandates and pandemic policies. He now advises the commissioner on medical and scientific issues.
FDA Commissioner Marty Makary addressed the memo on Fox News and said the data involving child deaths was collected during the Biden administration. Makary added that COVID-19 shots “worked well” for older or high risk Americans when the vaccine closely matched the circulating virus.
The FDA is now preparing broad changes to its vaccine approval framework. New guidelines, described in documents reviewed by The New York Times and The Washington Post, would require larger studies before approval of many vaccines. The rules could affect pneumonia vaccines, annual flu shots, combination vaccination schedules, and shots for pregnant women.
Prasad wrote that future studies must prove that vaccines prevent illness and not only show antibody production. He also called the current flu shot approval process a “catastrophe of low-quality evidence.” Drug makers would need to conduct larger randomized trials that include all demographic subgroups, which could slow development timelines.
Former FDA chief scientist Jesse Goodman told the Post that vaccines already undergo strict review. He said the agency historically approves vaccines based on strong scientific evidence.
The proposed guidelines align with Kennedy’s longstanding skepticism toward childhood vaccines. Critics argue the changes could make immunization programs less accessible and weaken public confidence.
In August, the FDA said it was considering revoking the emergency authorization of Pfizer’s COVID-19 vaccine for healthy children under five. Updated vaccines remain available for high risk groups, but not for routine use in otherwise healthy young Americans.
The FDA has not released additional details on the child deaths identified in the memo. Further information may come after the CDC advisory panel meets next week.