Report: FDA to Change Vaccine Approval Process Based on Agency’s Claim of Covid Vaccine-Related Deaths

Pharmaceutical Executive December 1, 2025
Nicholas Jacobus

Key Takeaways

• The FDA plans to revise its vaccine approval process due to concerns about COVID-19 vaccine-related child deaths.
• Dr. Vinay Prasad’s memo links 10 child deaths to COVID-19 vaccines, based on VAERS data analysis.
• Proposed changes include stricter safety and efficacy requirements, especially for vaccines for pregnant women and children.
• Experts criticize the claims, citing a lack of evidence and potential public harm from the memo’s assertions.

The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.

The FDA plans to alter its vaccine approval process based on allegations that the Covid vaccine resulted in the death of 10 children. In an internal memo obtained by CNN, Vinay...

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