A senior Food and Drug Administration (FDA) official, Vinay Prasad, has proposed significant changes to US vaccine regulation following an internal investigation linking at least ten child deaths to the COVID-19 vaccine. The findings, detailed in a memo published by The Washington Post, mark the first official US government acknowledgment of a causal relationship between the vaccine and fatalities in young people.
Investigation and Findings
Prasad directed FDA staff to analyze 96 deaths reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024. While VAERS accepts reports from anyone and includes unverified data, the analysis concluded that “no fewer” than ten deaths were likely attributable to the COVID-19 vaccine. Prasad acknowledges the true number may be higher due to underreporting.
“For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
The memo also criticizes past vaccine policies, particularly mandates imposed under the Biden administration, which Prasad argues coerced healthy children into receiving a vaccine with potentially fatal consequences.
Proposed Regulatory Changes
Prasad’s “path forward” includes several key reforms:
- Multivalent Vaccine Review: A deeper assessment of the safety of administering multiple vaccines simultaneously.
- Flu Vaccine Scrutiny: A reassessment of the annual influenza vaccine framework, which Prasad describes as based on “low-quality evidence.”
- Pregnancy Vaccine Standards: Stricter requirements for authorizing vaccines for pregnant women.
- Pneumonia Vaccine Efficacy: Demanding that pneumonia vaccine manufacturers demonstrate actual reduction in pneumonia cases, not just antibody production.
Controversy and Skepticism
The findings have sparked immediate controversy. Dr. Paul Offit of the Children’s Hospital of Philadelphia criticized Prasad for lacking concrete evidence, stating that the claims will unnecessarily scare the public. Offit argues that a thorough review of all data is needed before such conclusions are publicized.
Prasad responded to potential leaks of internal memos by warning staff against sharing information with the media, calling such behavior “unethical, illegal, and factually incorrect.”
Context and Implications
This development is significant because it directly challenges the widespread assumption of near-zero risk associated with COVID-19 vaccination in children. While VAERS data is often dismissed as anecdotal, Prasad’s internal FDA investigation adds weight to concerns about vaccine safety. The long-term effect of these findings could be decreased public trust in vaccine mandates and a push for more individualized risk assessments.
The situation highlights the complexities of balancing public health measures with individual safety, and the need for transparent, evidence-based policymaking.
The FDA and HHS did not immediately respond to requests for comment.
