US FDA Ups The Stakes In RSV Vaccine Race With Breakthrough Designations For Pfizer And Bavarian Nordic
Executive Summary
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.
You may also be interested in...
Recent US FDA Breakthrough Therapy Designations, From Mass Market Vaccines To Rare Diseases
Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.
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.
Sanofi And AstraZeneca Still Lead In RSV But Pfizer Has Chance To Challenge
Sanofi and AstraZeneca’s antibody nirsevimab is still likely to reach the market first, but Pfizer could be close behind with superior efficacy results.