A newly released FDA analysis examining reported pediatric deaths following COVID-19 vaccination is drawing renewed attention to vaccine safety monitoring and federal transparency.
The report, made public by Sen. Ron Johnson (R-Wis.), reviewed deaths reported to the FDA’s Vaccine Adverse Event Reporting System, commonly known as VAERS. The analysis evaluated whether reported deaths among children could potentially be linked to COVID-19 vaccines.
According to the document, seven pediatric deaths were classified as either “possible” or “probable” in relation to vaccination. No cases were classified as “certain.”
The review covered reports submitted through Aug. 14, 2025.
Findings
The FDA analysis stated that medical officers reviewed 96 unique U.S. pediatric death reports associated with COVID-19 vaccines.
The cases involved reports connected to Pfizer and Moderna vaccines administered to children under age 12.
| Vaccine Data Reviewed | Total |
|---|---|
| Pfizer reports | 79 |
| Moderna reports | 17 |
| Novavax reports | 0 |
| Total pediatric death reports | 96 |
Investigators classified the reports into several categories using the World Health Organization’s standardized causality assessment system.
The classifications included:
| Classification | Number of Cases |
|---|---|
| Probable | 2 |
| Possible | 5 |
| Unlikely | 62 |
| Unassessable/Unclassifiable | 27 |
| Certain | 0 |
The report emphasized that “possible” cases may also be explained by alternative medical causes, while “probable” cases were considered less likely to have another explanation, though one could not be ruled out.
Cases
According to the analysis, all seven possible or probable cases involved cardiac-related events.
The reported conditions included:
- Myocarditis
- Myocarditis with stress cardiomyopathy
- Cardiomyopathy without myocarditis
- Cardiac arrhythmia
The report stated:
| Case Characteristics | Details |
|---|---|
| Age range | 7 to 16 years |
| Male patients | 5 |
| Female patients | 2 |
| Vaccine involved | Pfizer only |
| Median symptom onset | 3 days |
Six of the cases reportedly occurred after Pfizer’s original monovalent vaccine, while one followed the bivalent version.
The FDA review also noted that autopsy reports were available for all seven cases considered possible or probable.
Context
The analysis highlighted the scale of pediatric vaccination during the review period.
According to the report, by Aug. 14, 2025:
| Pediatric Vaccine Administration | Doses Given |
|---|---|
| Pfizer Comirnaty | 95 million+ |
| Moderna Spikevax | 42 million+ |
Health officials have consistently stated that serious adverse reactions linked to COVID-19 vaccines remain rare compared with the number of doses administered.
Myocarditis, particularly in adolescent males, has been previously identified by U.S. and international health agencies as a known but uncommon risk associated with mRNA COVID-19 vaccines.
Most myocarditis cases reported after vaccination have been described as mild and responsive to treatment, according to earlier CDC and FDA guidance.
Release
The analysis became public after Sen. Ron Johnson released the document and criticized federal agencies for not publishing it earlier.
Johnson, who chairs the Senate Permanent Subcommittee on Investigations, said he had requested records related to pediatric deaths following COVID-19 vaccination in December 2025.
In a statement accompanying the release, Johnson said he believes additional documents may still exist and called on the Department of Health and Human Services to provide further records.
The report itself was dated Dec. 5, 2025.
Officials
The article also references leadership changes involving several FDA officials connected to earlier vaccine discussions.
Former Center for Biologics Evaluation and Research Director Vinay Prasad, MD, MPH, had previously referenced the analysis in a memo to staff in November 2025.
That memo reportedly stated that at least 10 children had died due to COVID-19 vaccination, though the released analysis documented a lower number of cases classified as possible or probable.
According to the report, Prasad left the FDA in March.
Other officials mentioned in connection with the earlier internal discussions included:
- Former FDA Commissioner Marty Makary, MD, MPH
- Former Acting Center for Drug Evaluation and Research Director Tracy Beth Hoeg, MD, PhD
The article stated those officials also later departed the agency.
Monitoring
VAERS, the reporting system used in the analysis, is jointly managed by the FDA and the Centers for Disease Control and Prevention.
The database allows healthcare providers, vaccine manufacturers, and members of the public to report adverse events occurring after vaccination.
Federal health agencies have repeatedly noted that reports submitted to VAERS do not automatically prove a vaccine caused a medical event. Reports are reviewed and investigated to determine whether there may be a causal relationship.
The FDA analysis described the findings as “new safety information” and noted that potential labeling changes could be considered.
No updated labeling decisions connected to the report were announced in the released document.
FAQs
What did the FDA review examine?
It reviewed pediatric death reports after COVID vaccination.
How many cases were considered probable?
Two cases were classified as probable.
Were any deaths deemed certain?
No deaths were classified as certain.
Which vaccines were involved?
The reviewed cases involved Pfizer vaccines.
What is VAERS?
A federal system for reporting vaccine adverse events.
Minnesota Fraud Case – Feeding Our Future Founder Sentenced to Nearly 42 Years