FDA Reports Covid Vaccine-linked Deaths in Children, Plans New Regulations

The Food and Drug Administration (FDA) has recently released findings indicating a concerning link between COVID-19 vaccinations and reported deaths among children. A memo authored by Dr. Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, details that at least ten children died after receiving the COVID-19 vaccine.

Key Findings from the FDA Memo

• The memo states that “no fewer than 10” of the 96 child deaths reported to the Vaccine Adverse Event Reporting System (VAERS) from 2021 to 2024 are linked to vaccination.
• Dr. Prasad suggests the actual number could be higher and criticizes the agency for neglecting safety concerns.
• Specifics such as the children’s ages, medical histories, and timelines are not included in the report.

Concerns About VAERS Data

Experts have raised alarms about the reliability of the VAERS reporting system. This database allows anyone to submit reports of adverse events, which may not always be accurate. Dr. Paul Offit, a pediatrician, described the memo as “irresponsible” and highlighted the inherent biases in self-reported data.

Link to Myocarditis

Dr. Prasad speculates that the child fatalities may be associated with myocarditis, an inflammation of the heart muscle, although he fails to provide supporting evidence. The FDA has redirected all media inquiries to the Department of Health and Human Services, which has not yet commented on the memo.

Criticism from Experts

Dr. Peter Marks, the former head of the FDA’s vaccine division, criticized the misuse of VAERS data. He stated that the agency is misclassifying reports and warned against the narrative potentially fostering misinformation. He further noted that COVID-19 infection itself poses a greater risk of myocarditis than the vaccines do.

Proposed Regulatory Changes

The memo by Dr. Prasad also suggests several regulatory changes. He argues for a reassessment on how various vaccines, including annual flu shots, are evaluated. Additionally, he claims the current standards for pneumonia vaccines need reevaluation to ensure their efficacy.

Upcoming CDC Advisory Committee Meeting

As the FDA prepares for a two-day CDC advisory committee meeting, discussions will focus on the childhood vaccine schedule and upcoming hepatitis B vaccinations. Earlier this year, the FDA and CDC narrowed COVID-19 vaccine eligibility to individuals aged 65 and older and those with specific health conditions.

Context of Misinformation

Prominent figures, including Robert F. Kennedy Jr., an anti-vaccine activist, have criticized COVID-19 vaccines, particularly mRNA-based vaccines. Despite these claims, extensive research continues to support the safety and effectiveness of COVID-19 vaccines in children. A recent analysis in JAMA Pediatrics found that vaccinated children had lower infection rates and hospitalizations than their unvaccinated peers.

Conclusion

The FDA’s memo raises important questions regarding COVID-19 vaccines and their impact on child health. While the concerns highlighted are significant, it’s crucial to approach these findings with a careful review of the underlying data and research. Misinformation can have serious consequences, especially when it comes to public health decisions.