The FDA confirmed 10 children died after receiving COVID vaccines. SAN verified the information.

U.S. Food and Drug Administration officials recently documented at least 10 child deaths potentially connected to COVID-19 vaccination, according to an internal memo circulated last week. The memo, signed by Vinay Prasad, director of the FDAs Center for Biologics Evaluation and Research, noted that the deaths were "likely, probable, or possible" in relation to the vaccines.

The FDAs conclusions came from an analysis of the Vaccine Adverse Event Reporting System (VAERS), a national platform that tracks potential vaccine safety issues. Researchers at Straight Arrow News (SAN) reviewed VAERS records and identified 83 reports of children dying within two weeks after vaccination.

Experts have challenged these findings. Domenico Motola, a pharmacology professor in Italy, stated the claims are unsubstantiated without detailed data, methodology, and causal analysis. VAERS itself collects unverified reports from anyone, including healthcare providers, vaccine manufacturers, and the public. Each submission requires further investigation to confirm if a vaccine caused the reported event, but the public data only shows raw reports.

The FDAs memo analyzed 96 VAERS death reports from 2021 to 2024 and concluded that 10 were associated with COVID-19 vaccines. The memo also noted that this number could be underestimated due to reporting gaps or overestimated because VAERS reports are unverified.

Prasads memo did not provide details on research methods or the specific types of vaccines administered. Several public health officials criticized the memo. Michael Osterholm, director at the University of Minnesotas Center for Infectious Disease Research and Policy, called it "irresponsible science," while former FDA vaccine chief Peter Marks described the agencys environment as highly toxic.

Prasad, a former hematologist-oncologist and epidemiology professor, has previously highlighted concerns about myocarditis, an inflammation of the heart, which has been observed at slightly higher rates in males after COVID-19 vaccination. The FDA recently updated Pfizer and Moderna vaccine warnings to reflect this risk, and Pfizer acknowledged it while noting the risk of myocarditis after infection is significantly higher than after vaccination.

VAERS Data Review

SAN analyzed VAERS files from 2021 through 2025, containing hundreds of thousands of entries. After excluding duplicates, deaths unrelated to vaccination, and incomplete data, 83 child deaths were recorded within two weeks of vaccination. Of these, 34 involved COVID-19 vaccines26 Pfizer and 8 Moderna. Other vaccines included flu shots (12 cases) and Hepatitis A (9 cases). The majority of reports involved routine childhood vaccines such as DTaP and combination shots.

SAN presented these findings to the FDA and CDC, but neither agency provided comment. The memo did not explain how the 10 COVID-19 vaccine-related deaths were identified from VAERS reports.

Safety Context and Vaccine Benefits

Moderna reaffirmed its vaccines safety, citing extensive global monitoring systems that have not revealed new safety concerns for children or pregnant women. Numerous studies and large clinical trials confirm that COVID-19 vaccines are generally safe, with serious side effects being rare. Myocarditis remains a noted risk, particularly in young males, with estimates ranging from 12 to 118 cases per million vaccinated children.

Comparing vaccine-related deaths with COVID-19 fatalities is complex. Between 2019 and 2023, over 1 million Americans died from COVID-19, including more than 1,600 children. While older adults and those with underlying conditions face the highest risk, Prasad noted that the vaccines benefits for younger populations are less clear. He emphasized that it is impossible to know exactly how many child lives were saved or lost due to vaccination.

In conclusion, while the FDA memo highlights potential risks, the overall safety and benefits of COVID-19 vaccines remain supported by extensive research and monitoring.

Author's Commentary: Contextualizing the FDA Memo on Child Deaths

The recent FDA memo documenting 10 child deaths potentially linked to COVID-19 vaccination requires careful interpretation. While the memo signals a possible association, it does not establish causality. The deaths were classified as "likely, probable, or possible," reflecting uncertainty rather than confirmed vaccine-related fatalities.

Analysis of VAERS data by independent researchers shows 83 child deaths within two weeks of vaccination, with 34 cases involving COVID-19 vaccines. However, VAERS reports are unverified and include submissions from the public, healthcare providers, and manufacturers. Each report requires further investigation before any definitive conclusions can be drawn.

Experts have emphasized that the lack of detailed methodology in the FDA memo limits its scientific reliability. Public health authorities continue to stress that COVID-19 vaccines remain largely safe for children, with myocarditis being a rare but recognized side effect, particularly in young males.

Ultimately, while vigilance is essential and the FDA’s review contributes to transparency, existing data support that the benefits of COVID-19 vaccination—particularly in preventing severe illness and death—still outweigh the risks for most children. Continuous monitoring and clear communication are key to maintaining public trust in vaccine programs.

Sources:

• The FDA said 10 kids died from COVID vaccines. SAN checked the data.