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.
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RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates
Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.
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.