USA Examines Child Deaths - FDA Wants to Tighten Vaccine Approval Regulations
The U.S. Food and Drug Administration (FDA) is moving to considerably tighten approval regulations for vaccines following new internal assessments suggesting a link between COVID-19 vaccinations and deaths in children. This development was reported by the Washington Post.
Vinay Prasad, the FDA’s top vaccine regulator, stated his team has concluded “that corona vaccinations are linked to deaths in children” and that a new regulatory approach is necessary. The FDA has not yet released specific details regarding the cases under examination.
These assessments are based on internal agency analyses and reports submitted to the Vaccine Adverse Event Reporting System (VAERS). While a VAERS entry does not automatically confirm a vaccine-related cause, it typically initiates further medical investigation.
Agency documents reviewed by Reuters indicate the FDA is currently investigating the deaths of at least 10 children following COVID-19 vaccination. Cases under scrutiny include instances of myocarditis, or inflammation of the heart muscle. However, a definitive causal link between the vaccinations and these deaths has not yet been established, and the specific vaccines administered in these cases remain undisclosed by the FDA and in cited media reports.
Experts note that previous evaluations conducted by the Centers for Disease Control and Prevention (CDC) did not reveal a clear connection between the vaccines and child deaths. Though, the FDA’s recent statements suggest an internal shift within the agency towards stricter security requirements and increased data transparency, prompted by internal evaluations suggesting a potential connection.
The FDA plans to introduce the new regulations in the coming weeks, potentially requiring larger studies, extended observation periods, and more rigorous assessment of potential side effects. The agency has declined to provide detailed comments on the ongoing investigations.
This is not the first time the FDA has examined potential links between COVID-19 vaccines and adverse events in children. The Berliner Zeitung previously reported in September that the FDA was investigating 25 deaths in children following vaccination. Then-FDA Commissioner Marty makary acknowledged the reports but stressed the causes remained unclear. The report stemming from that investigation has not yet been published. Vinay Prasad’s current statements indicate a reassessment is underway within the FDA.
