FDA Links COVID Vaccines to 10 Child Deaths, Plans Stricter Reviews
The Food and Drug Administration (FDA) has announced plans to implement stricter reviews of COVID vaccines, particularly concerning their safety for children. This decision follows recent comments by FDA officials, including Commissioner Marty Makary, who expressed concerns over the potential risks associated with these vaccines.
FDA’s New Vaccine Approval Process
In a recent Fox News interview, Makary emphasized that the FDA would no longer “rubber-stamp” new vaccine products without adequate evidence of their effectiveness. He noted that this shift reflects a growing commitment to scientific integrity in the vaccine approval process.
Dr. Vinay Prasad, the agency’s leading vaccine regulator, indicated through an internal email that the FDA is revising its approach to vaccine evaluations. The modifications include:
- Changing the annual flu vaccine review framework.
- Updating vaccine labeling to reflect more accurate safety information.
- Imposing stricter requirements for vaccines administered to pregnant women.
- Requiring pneumonia vaccine manufacturers to demonstrate a reduction in disease rather than merely the creation of antibodies.
Link to Child Deaths and Public Response
Makary mentioned that the FDA has linked 10 child deaths to the COVID vaccine, raising considerable concern. However, detailed evidence supporting this claim has not been made public, prompting skepticism from other health experts.
Dr. Paul Offit, a leading figure in vaccine education, criticized the lack of shared evidence regarding these reported deaths. He urged the FDA to provide data for expert review to ascertain the validity of such claims.
Analysis of Reported Deaths
The internal email from Dr. Prasad noted an analysis of 96 reported deaths linked to the COVID vaccine from 2021 to 2024. It suggested that while 10 deaths were confirmed as vaccine-related, the actual number could be higher. This conclusion has been met with skepticism, as many health professionals stress the importance of thorough investigation and transparency in public health matters.
Dr. Jesse Goodman, former FDA official, defended the established practices for vaccine approvals, arguing that current methods have been instrumental in providing effective vaccinations to the public.
Concerns Regarding Vaccine Effectiveness
Some health experts, like Michael Osterholm, challenge the portrayal of COVID’s severity in children, citing that thousands of pediatric deaths occurred during the pandemic. He criticized Prasad’s assertions and highlighted that the FDA’s reported deaths from vaccines have not been reviewed or published in credible medical literature.
Future Implications
The FDA’s reassessment coincides with an upcoming meeting of the CDC’s Advisory Committee on Immunization Practices, scheduled for December 4-5. The committee is expected to discuss potential changes to the childhood vaccination schedule, which may lead to delayed or spaced-out vaccinations. Experts warn that such changes could reduce children’s immunity and expose them to previously controlled diseases.
As the FDA continues to evaluate vaccine safety, Moderna has responded to recent allegations by reiterating that its vaccine remains safe, citing numerous studies and ongoing monitoring. The company maintains that no significant new safety concerns have emerged.
As these discussions unfold, public confidence in vaccine safety continues to be a critical concern, with many experts urging for a balanced approach that prioritizes both safety and accessibility to vaccinations.
