Based on the most recent news reports from November 29, 2025, your query likely refers to a major developing story regarding the FDA and COVID-19 vaccines.
Here is the breakdown of the current situation based on the available reporting:
The Latest News (November 2025)
* The Announcement: Reports from The Washington Post and other outlets indicate that the FDA is implementing stricter vaccine approval requirements. This shift follows an internal review by FDA officials who concluded that COVID-19 vaccines contributed to the deaths of at least 10 children.
* The Source: This conclusion reportedly comes from an internal FDA email sent by agency official Vinay Prasad. The review was part of a broader investigation into reports submitted to the Vaccine Adverse Event Reporting System (VAERS).
* The Context: FDA Commissioner Marty Makary and his team have been reviewing pediatric death reports. While previous broad scientific consensus and CDC data had characterized such outcomes as extremely rare or unproven, this new leadership at the FDA is asserting a causal link in these specific cases, marking a significant shift in federal health policy.
* The Consequence: As a result of these findings, the FDA is moving to demand more rigorous testing and safety data for future vaccine approvals, specifically regarding childhood immunizations.
Important Context on Vaccine Safety
* Controversy: This new stance represents a departure from the FDA's prior position and the consensus of many major medical organizations, which have historically maintained that the benefits of vaccination outweigh the risks. The shift is described in reports as a "profound revelation" by the current FDA team but has drawn sharp criticism from other public health experts who worry it may hinder response to future outbreaks.
* VAERS Data: The investigation relied on reports from VAERS. It is important to note that historically, VAERS accepts reports from anyone (doctors, patients, parents), and a report appearing in the database does not predominantly prove causality on its own; however, the FDA's recent internal analysis claims to have confirmed a link in these specific 10 instances.
Other Historical Incidents
If you were referring to a different historical event, there are rare past incidents involving small clusters of deaths, though usually due to procedural error rather than the vaccine itself:
* Samoa (2018): Two infants died after receiving the MMR vaccine. Investigations proved this was not caused by the vaccine itself, but by a nurse accidentally mixing the vaccine powder with a muscle relaxant instead of water.
* Cutter Incident (1955): In a historical case, a defective batch of polio vaccines (which was not properly inactivated) caused paralysis in many children and 10 deaths. This led to radically tighter safety regulations at the time.
Next Step: Would you like more specific details on the new FDA guidelines that are being proposed as a result of this report?
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