The Food and Drug Administration (FDA) is set to significantly alter its vaccine approval process following claims that Covid-19 vaccines were linked to the deaths of at least 10 children. Dr. Vinay Prasad, the FDA's top vaccine regulator, announced the changes in an internal memo, sparking debate among medical experts.
New Approval Process
According to reports, Prasad's memo outlines several key changes, including:
- Stricter Safety and Efficacy Data: Pharmaceutical manufacturers will need to provide more robust data before approval.
- Re-examination of Flu-Shot Policies: The FDA plans to reassess annual flu vaccine policies.
- Limits on Simultaneous Vaccinations: The agency is considering restrictions on administering multiple vaccines at once.
- Tighter Restrictions on Vaccines for Pregnant Women: New rules will impose stricter requirements for vaccines given to pregnant women.
Controversy and Expert Reactions
The announcement has sparked intense debate, with some experts questioning the evidence supporting the claims of vaccine-related deaths. Dr. Paul Offit, a prominent vaccine expert, called the move "dangerous and irresponsible," emphasizing the need for rigorous scientific review.
"The way it works is, if you think you have an extraordinary claim, you should back it up with extraordinary evidence," Offit said. "He should have submitted it to an excellent journal where it can be reviewed by subject matter experts."
Concerns and Uncertainty
The memo's lack of detailed data has raised concerns among experts, who are calling for further investigation into the reported deaths. The FDA has not publicly released information on the children's ages, health conditions, or the causal relationship between vaccination and death [1
Looking Ahead
As the FDA moves forward with its new approval process, the scientific community awaits more information on the evidence supporting these changes. The controversy highlights the importance of rigorous scientific scrutiny in vaccine development and approval.
For more information on vaccine safety and the FDA's approval process, visit the FDA's official website or consult reputable sources like STAT News and The New York Times [12.
Stay Informed, Stay Safe
Stay up-to-date with the latest developments on vaccine safety and approval. Consult trusted sources and talk to your healthcare provider about any concerns.
[FDA claims Covid vaccine caused kids’ deaths. Experts are ... - STAT](https://www.statnews.com/2025/11/29/covid-vaccine-deaths-fda-memo-vinay-prasad/)
[FDA to raise hurdles for vaccines, faulting COVID shots for 10 kids' deaths](https://www.wcbe.org/npr-news/2025-11-29/fda-to-raise-hurdles-for-vaccines-faulting-covid-shots-for-10-kids-deaths)
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