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Today, Pfizer announced that its investigational respiratory syncytial virus (RSV) vaccine PF-06928316 (also known as RSVpreF) has been granted Breakthrough Therapy Designation by the U.
The Breakthrough Therapy award was primarily based on positive results from a proof-of-concept Phase 2a clinical trial
RSV is an infectious pathogen and is divided into two subtypes according to antigenicity: type A and type
Pfizer's investigational RSV vaccine candidate contains two RSV prefusion F glycoproteins designed to provide optimal protection against RSV A and RSV
In September 2021, Pfizer announced the initiation of a Phase 3 clinical trial to test the efficacy, immunogenicity and safety of RSVpreF in adults over 60 years of age
"The clinical and economic burden posed by RSV represents an urgent need, and we look forward to continuing our dialogue with the FDA to expedite the development of RSV vaccine candidates," said Kathrin U.
References:
[1] Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in Older Adults.
