מה דעתך על הדרישה החדשה של ראש ה-FDA החדש?

לערוך מחקר חדש על חיסון NOVAVAX לקורונה לפני חידוש אישור החירום שלו? On the Novavax question, my views evolve with data. I have been a fan of traditional vaccine platforms for Covid, especially in 2021, when it provided another pathway for people uncomfortable with mRNA to get vaccinated. But the big Novavax 2020-2021 study excluded people with natural immunity to Covid. Today, there is broad population immunity, and the big question is does it provide a benefit? Without a study on the new formulation and product, we can’t give an honest evidence-based answer to that question. These are new vaccine products, not the tried-and-true flu shot that has been around for 80 years. If we had a study showing that Covid boosters help keep people out of the hospital today, it could significantly increase the low Covid vaccine uptake rate that we have today. Look, 85% of healthcare workers declined the latest Covid booster vaccine last fall. Should we accept that and just keep pounding on parents to get their healthy 12-year-old daughter a 7th Covid jab this fall? Or should we make evidence-based recommendations based on a meaningful study showing a clinical benefit today? https://insidemedicine.substack.com/p/exclusive-in-conversation-with-fda