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FDA Analysis of Pediatric Deaths and COVID-19 Vaccines Reveals Discrepancies in Official Conclusions

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FDA Analysis of Pediatric Deaths After COVID-19 Vaccination Reveals Internal Discrepancies

The U.S. Food and Drug Administration (FDA) has released an analysis of 96 reports of child deaths submitted to the Vaccine Adverse Event Reporting System (VAERS), while internal communications suggest the agency is planning stricter vaccine approval standards. Conflicting conclusions have emerged from different agency representatives regarding the number of pediatric deaths potentially linked to COVID-19 vaccines.

FDA Analysis of Pediatric Death Reports

The FDA's analysis, examining 96 reports of child deaths submitted to VAERS through August 14, 2025, concluded that no deaths were classified as "certain" to be linked to COVID-19 vaccination. The agency classified five deaths as "possible" and two as "probably" associated with vaccination. The report stated these categories do not establish causation and that alternative explanations could not be ruled out.

The analysis involved review of medical records, death certificates, and in some cases interviews with parents. Most of the seven cases classified as possible or probable involved myocarditis, a rare heart inflammation associated with COVID-19 vaccines, particularly in adolescent boys and young men. The FDA instructed Pfizer and Moderna to update vaccine labels regarding myocarditis risk in June 2025.

Limitations of VAERS Data

VAERS is a passive reporting system co-sponsored by the FDA and the Centers for Disease Control and Prevention (CDC). The FDA has stated that reports submitted to VAERS alone do not establish that a vaccine caused the reported event. The agency makes VAERS data publicly available.

Internal Discrepancies and Statements

Commissioner's Statements

FDA Commissioner Marty Makary stated on Fox News that the agency would no longer "rubber-stamp new products that don't work." He also stated that an FDA analysis linked 10 pediatric deaths to the COVID-19 vaccine during the current administration, without providing specific methodological details. Makary commented that in 2020, COVID vaccines reduced illness severity and saved lives, but argued that recommending annual COVID vaccinations for a 6-year-old is not scientifically supported.

"The FDA analysis linked 10 pediatric deaths to the COVID-19 vaccine." — Commissioner Marty Makary

Internal Email

An internal email from Dr. Vinay Prasad, the FDA's lead vaccine regulator, was reviewed by NPR, PBS News Hour, and The Washington Post. The email stated that the FDA's biostatistics and pharmacovigilance team analyzed 96 reported deaths from 2021 to 2024, concluding that 10 children died "after and because of" the COVID-19 vaccine. Prasad indicated the true number might be higher. The email noted that causality in case reports is typically assessed on a subjective scale ranging from certain to unlikely.

The email also outlined several planned changes to vaccine review processes:

  • Modification of the annual flu vaccine framework
  • Updates to vaccine labels
  • Stricter authorization requirements for vaccines for pregnant women
  • Requirement for pneumonia vaccine manufacturers to demonstrate disease reduction rather than solely antibody generation
  • Questioning of the practice of co-administering multiple vaccines

Report Transparency

The FDA analysis was made public after Senator Ron Johnson sent a letter to HHS Secretary Robert F. Kennedy Jr. regarding COVID-19 vaccine safety transparency.

In November 2025, Prasad claimed, without releasing supporting evidence, that the agency had identified at least 10 previously unreported child deaths tied to the vaccines. His claims were referenced in proposals to change FDA vaccine review processes.

Officials from the Department of Health and Human Services and the FDA did not immediately respond to requests for comment regarding the analysis or proposed changes to vaccine review standards.

Expert Responses

Dr. Jesse Goodman, former FDA chief scientist, stated the report was carefully done but noted that implying a large number of children were killed by the vaccine goes beyond the evidence. Goodman also described the FDA's Center for Biologics Evaluation and Research as "globally recognized" and defended the use of "immunologic endpoints like antibody levels" for accelerated approval of certain vaccines, stating that scientific evidence supports their use with subsequent confirmation studies.

Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children's Hospital, stated that the risk of myocarditis from vaccination is up to 100 cases per million doses, but infections are the primary cause of myocarditis.

Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, stated that Prasad has not shared the evidence for the deaths. Offit commented that without evidence, it requires trust on an important issue and could cause unnecessary public concern. He recommended that all evidence be provided for expert review.

"Without evidence, it requires trust on an important issue and could cause unnecessary public concern." — Dr. Paul Offit

Epidemiologist Michael Osterholm challenged Prasad's statement that "COVID-19 was never highly lethal for children," noting 1,597 pediatric deaths from COVID-19 in 2020-2022. Osterholm stated that the 10 reported deaths have not been presented for review by the medical and public health communities or published in medical literature, and concluded that without third-party expert review, these cases cannot be accepted as vaccine-associated deaths.

Manufacturer Responses

Moderna, whose COVID-19 vaccine is approved for children as young as 6 months, referenced a September statement. The company stated that multiple published, peer-reviewed studies indicate its shot is safe and that it is "not aware of any deaths in the last year or pertinent new information from prior years." Moderna also stated it monitors its vaccine's safety with regulators in over 90 countries, and these systems have not reported new or undisclosed safety concerns in children or pregnant women.

Pfizer did not immediately respond to requests for comment.

Upcoming CDC Committee Meeting

Prasad's email precedes a scheduled two-day meeting of the CDC's Advisory Committee on Immunization Practices (ACIP) on December 4-5. The ACIP is conducting a major review of the childhood vaccination schedule for diseases including measles, mumps, rubella, polio, and hepatitis B. Potential outcomes include delaying inoculation timing, spacing out vaccinations, or reformulating some vaccines. Public health experts have expressed concern that changes could lead to reduced vaccination rates and the reemergence of eradicated diseases.

Policy Evolution

These developments follow the FDA's August 2025 restriction of eligibility for updated COVID vaccines, concurrent with the agency's stated plan to require more evidence regarding vaccine safety and effectiveness. The proposed changes to vaccine review standards could increase the difficulty and cost of vaccine approvals, potentially affecting vaccine availability. Robert F. Kennedy Jr. has publicly questioned vaccines.