FDA Chiefs Warn Over Proposed Vaccine Overhaul
- This article details a conflict between current FDA leadership (specifically Vinay Prasad,head of the Centre for Biologics Evaluation and Research) and a group of former FDA commissioners regarding...
- * Disagreement over Covid Vaccine & Child Deaths: Prasad sent a memo stating FDA scientists identified 10 cases of child deaths possibly linked to Pfizer and Moderna covid...
- In essence, the article portrays a clash between a data-driven, cautious approach to vaccine regulation (favored by the former commissioners) and a potentially more reactive and less scientifically...
This article details a conflict between current FDA leadership (specifically Vinay Prasad,head of the Centre for Biologics Evaluation and Research) and a group of former FDA commissioners regarding changes to vaccine policy. Here’s a breakdown of the key points:
* Disagreement over Covid Vaccine & Child Deaths: Prasad sent a memo stating FDA scientists identified 10 cases of child deaths possibly linked to Pfizer and Moderna covid vaccines.
* Former Commissioners’ Response: Nearly all FDA commissioners since 1990 (representing both Republican and Democratic administrations) co-authored a piece criticizing prasad’s approach. They argue his conclusions are not supported by the data and his proposed changes to vaccine regulation are misguided.
* VAERS Concerns: The former commissioners emphasize that the Vaccine Adverse Event Reporting System (VAERS) – the source of the 10 cases – cannot prove causation. it only reports events following vaccination.
* Importance of Established Procedures: They stress the importance of maintaining established scientific processes, open deliberation, and evidence-based decision-making, rather than unilateral changes based on limited data.They believe the Covid experience shouldn’t lead to abandoning sound regulatory practices for other vaccines.
* Specific Policy Change at Issue: The core of the disagreement revolves around Prasad’s apparent desire to stop using antibody levels to assess the effectiveness of updated vaccines (like those for flu and Covid). The former commissioners argue this would hinder the ability to adapt vaccines to evolving viruses.
* Unanimity of Concern: The striking aspect is the unified front presented by the former commissioners, highlighting the seriousness of their concerns about the direction Prasad is taking the FDA.
In essence, the article portrays a clash between a data-driven, cautious approach to vaccine regulation (favored by the former commissioners) and a potentially more reactive and less scientifically rigorous approach (represented by Prasad’s recent actions).