Firms Hope To Adapt COVID Vaccine Trial Design, FDA Communication Approaches To Other Diseases
Moderna has adopted more inclusionary enrollment criteria and real-time epidemiology monitoring for its RSV vaccine program, while Pfizer is expanding its internal ‘Lightspeed’ approach. US FDA is considering how to extend the fast, frequent and informal interactions.
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US FDA Ups The Stakes In RSV Vaccine Race With Breakthrough Designations For Pfizer And Bavarian Nordic
New breakthrough therapy designations bolster Pfizer’s maternal RSV vaccine and Bavarian Nordic’s older adult program, while Sanofi/AstraZeneca prepare to submit nirsevimab BLA and GSK deals with fallout of safety-driven Phase III trial pause.
Uwe Schoenbeck, CSO of external science and innovation at Pfizer, knows the company set itself a high bar during the COVID-19 pandemic after rapidly bringing a breakthrough vaccine to market. While the circumstances for the development of Comirnaty were truly unique, Pfizer does not expect to rest on its laurels when it comes to innovative R&D.
If they reach a public disclosure agreement, a handful of sponsors will be admitted to a new pilot program that allows four meetings with the FDA on rare disease endpoint issues.