Pfizer Receive the US FDA’s Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine for the Prevention of RSV
Shots:
- The US FDA has granted BTD to RSV vaccine, PF-06482077 or RSVpreF for the prevention of RSV-associated lower respiratory tract illness in infants aged birth to ≥6mos. by active immunization of pregnant women
- The designation was based on the results from the P-IIb POC study to evaluate the safety and immunogenicity of RSVpreF in healthy pregnant women aged 18 through 49yrs. with RSV
- The company has initiated the P-III (RENOIR) study to evaluate the efficacy, immunogenicity, and safety of RSVpreF in adults aged ≥60yrs. with RSV & the results from the study are expected in H1’22. The company also plans to advance the therapy in the P-III trial for the same indication
Ref: Businesswire | Image: Pfizer
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