FDA Acknowledges Potential Link Between COVID-19 Vaccines and Deaths of At Least 10 Children
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A new internal review suggests a possible connection between COVID-19 vaccinations and the deaths of at least 10 children who experienced heart inflammation, marking the first time the Food and Drug Administration has publicly acknowledged such a link.
The revelation, contained in a Friday memo from the FDAS chief medical and scientific officer, Dr. Prasad, is based on an initial review of 96 deaths reported between 2021 and 2024. The agency staff attributed these deaths to vaccination as “likely, probable, or possible.”
“These deaths are related to vaccination,” Prasad wrote, adding that the findings represent “a profound revelation.” He further stated, “It is challenging to read cases where kids aged 7 to 16 may be dead as a result of COVID vaccines.”
The analysis,based on an initial review of 96 deaths reported between 2021 and 2024,”concludes that no fewer than 10 are related” to COVID-19 vaccinations. The memo did not disclose the specific health conditions of the children involved, nor did it identify the vaccine manufacturers. Prasad has announced plans to tighten vaccine oversight in light of these findings.
Policy shift Under Kennedy Administration
The policy change spearheaded by Kennedy, a longtime critic of vaccines prior to his appointment, reflects a significant departure from the strong endorsements of the vaccines issued during the Trump and Biden administrations. During the height of the pandemic in 2020, and in the years that followed, health officials consistently promoted COVID-19 vaccines as a critical tool in preventing severe illness and death. Kennedy has previously linked vaccines to autism and advocated for a comprehensive overhaul of the nation’s immunization policies.
Concerns Over Data and Peer Review
The FDA’s findings have already drawn criticism, particularly regarding the lack of peer review. The New York Times reported that the review has not been published in a medical journal, and the Centers for Disease Control and Prevention’s vaccine committee is scheduled to meet next week to discuss the matter.
Dorit Reiss, a professor of law at UC law San Francisco specializing in vaccines and law, questioned the basis for suggesting changes to vaccine approvals based on an unpublished inquiry. “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, was a vocal opponent of COVID-19 vaccine and mask mandates before returning to his role as the FDA’s chief medical and scientific officer in September. He currently advises the FDA commissioner and other senior officials on emerging medical and scientific issues.
Weighing Risks and Benefits
Prasad argued in the memo that it is currently impossible to determine whether the benefits of COVID-19 vaccination outweigh the risks. “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.”
data from the CDC indicates that 1,071 people aged 5 to 18 died of COVID-19 between January 4, 2020, and June 24, 2023. While most vaccine experts continue to maintain that COVID-19 vaccinations are effective,the new FDA review raises critical questions about the potential risks,particularly for young people.
Nuance in vaccine Effectiveness
Despite the concerns raised regarding pediatric deaths, FDA Commissioner Marty Makary emphasized the continued effectiveness of the COVID-19 vaccine for older and at-risk populations. “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 stated during a Saturday interview on Fox News’ “Fox and Friends.”
Recent studies support this assertion, with one published last month finding that updated vaccine versions effectively prevented severe outcomes, such as hospitalizations and death, among veterans.
