US FDA grants Breakthrough Therapy Designation to Pfizer’s Respiratory Syncytial Virus vaccine candidate

Pfizer yesterday announced that its Respiratory Syncytial Virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.

The decision is primarily informed by the positive results of a proof-of-concept, phase IIa study evaluating the safety, immunogenicity and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age, the company said in a statement.

It further added that in September 2021, Pfizer announced the initiation of RENOIR (RSV vaccine Efficacy study iNOlder adults Immunised against RSV disease), a phase-III clinical trial (NCT05035212) evaluating the efficacy, immunogenicity and safety of a single dose of RSVpreF, in adults aged 60 years or older. This study remains ongoing.

The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s), concluded the statement.