FDA to Revamp Vaccine Approval, Citing Child Deaths from COVID-19 Shots

A senior official from the Food and Drug Administration (FDA) announced a major overhaul of the vaccine approval process. This decision comes in light of allegations that COVID-19 vaccinations may have contributed to the deaths of 10 children.

Details of the FDA’s Announcement

Dr. Vinay Prasad, the FDA’s chief medical and scientific officer, disclosed the agency’s plans in an internal memo. He noted that healthy children, who are at a low risk of severe outcomes from COVID-19, were pressured to receive the vaccine due to mandates imposed by the Biden administration.

Concerns Over Vaccine Safety

• Prasad did not disclose specific details about the alleged child deaths.
• He mentioned an initial analysis linking 10 out of 96 deaths to the vaccine.
• Prasad expressed doubts over the necessity of vaccinating children against COVID-19, comparing the virus to other respiratory illnesses.

While acknowledging the overall benefits of vaccines, Prasad emphasized that each vaccine must be appropriately administered and evaluated for safety. He argued for a more rigorous approval process that requires substantial evidence before any vaccine is authorized.

Proposed Changes to Vaccine Approval

The proposed changes aim to enhance the safety and efficacy standards for vaccines. Key points include:

• Stricter evidence requirements for vaccines for pregnant women.
• Trials for pneumonia vaccines must demonstrate a reduction in disease, not just antibody production.
• A revision of the annual flu vaccine framework.

Prasad’s memo highlights a commitment to increasing transparency and ensuring safety is the priority in vaccine labeling. However, the implementation of these changes may lead to longer study durations and a slower approval process.

Implications of the Changes

Prasad has invited discussions regarding the new framework, indicating that some staff may have opposing views. He urged dissenting staff members to resign if they do not align with the FDA’s new direction.

Context of the Announcement

This memo aligns with the perspectives of HHS Secretary Robert F. Kennedy Jr. Kennedy has historically expressed skepticism towards vaccines and led initiatives that reduced funding for mRNA vaccine research. Under his leadership, significant changes have been made regarding vaccine advisory boards and recommendations.

A meeting is scheduled for next week for the CDC’s Advisory Committee on Immunization Practices to review the childhood vaccine schedule, particularly concerning hepatitis B vaccinations—a measure historically vital in combating disease among U.S. infants.

As debates about the safety and necessity of vaccines continue, the FDA’s adjustments signal a shift towards more cautious and evidence-based vaccine authorization processes.