Pfizer’s Respiratory Syncytial Virus Vaccine (PF-06928316 or RSVpreF) Receives the US FDA’s Breakthrough Therapy Designation for RSV
Shots:
- The US FDA has granted BTD to PF-06928316 or RSVpreF for the prevention of lower respiratory tract disease caused by RSV in individuals aged ≥60yrs.
- The designation was based on the P-IIa PoC study evaluating the safety, immunogenicity & efficacy of a single dose of RSVpreF (120µg) in a human viral challenge model in healthy adults aged 18 to 50yrs. with RSV
- The P-III (RENOIR) trial is currently ongoing to evaluate the efficacy, immunogenicity & safety of RSVpreF in adults aged ≥60yrs. for the same indication. RSVpreF also received BTD from the US FDA for the prevention of RSV-associated lower respiratory tract disease in infants aged birth to 6mos.
Ref: Pfizer | Image: Pfizer
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