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Pfizer (PFE) RSV Vaccine Candidate BLA Gets FDA's Priority Tag

Pfizer PFE announced that the FDA has accepted its biologics license application (BLA) seeking approval of its bivalent respiratory syncytial virus (RSV) vaccine candidate, RSVpreF for the prevention of lower respiratory tract disease (LRTI) caused by RSV in older adults (aged 60 and above). With the FDA granting priority review to the BLA, a decision is expected in May 2023.

The FDA grants Priority Review to regulatory applications for vaccines that, if approved, would offer better safety or effectiveness for the treatment or prevention of some serious conditions in comparison to standard applications.

Currently, there are no FDA-approved vaccines against RSV infections anywhere in the world. Older adults are at maximum risk to get RSV disease. The LRTI-RSV disease causes a high rate of morbidity and mortality in older adults and young kids.

Pfizer’s BLA was based on data from a phase III study called RENOIR on the RSV candidate. The study's primary objective was to assess the safety and efficacy of the vaccine for the prevention of moderate-to-severe LRTI-RSV during the first RSV season.

Data from the interim analysis of the RENOIR study demonstrated vaccine efficacy of 66.7% in participants with two or more RSV-associated symptoms. However, the vaccine efficacy was 85.7% in participants with the more severe disease having three or more symptoms. In the study, the vaccine was well-tolerated, with no safety concerns.

Pfizer is also conducting a phase III study on RSVpreF infants through maternal immunization.

Pfizer’s stock is down 14.3% this year so far against an increase of 10.8% for the industry.

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GSK’s GSK RSV vaccine for older adults is also under FDA priority review with a decision expected on May 3, 2023. Regulatory applications seeking approval of GSK’s RSV vaccine are under review in Japan and Europe as well.

AstraZeneca AZN and Sanofi’s SNY RSV vaccine called Beyfortus/nirsevimab was approved in Europe for protection against LRTI caused by RSV in newborns and infants in November. A similar application is under review in the United States.  The approval for Beyfortus was based on data from the MELODY phase III and other phase IIb studies conducted jointly by AstraZeneca and Sanofi.

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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