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Pfizer's (PFE) RSV Vaccine for Older Adults Gets FDA Approval

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Pfizer (PFE - Free Report) announced the FDA has granted approval to its respiratory syncytial virus (RSV) vaccine for older adults. The bivalent RSV prefusion F (RSVpreF) vaccine will be marketed by the name of Abrysvo for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years and older

The FDA approval for the RSV vaccine for older adults was based on data from the RENOIR study, which had enrolled approximately 37,000 participants. In February, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) had voted in favor of RSVpreF for older adults. The committee voted 7 to 4 on safety and 7 to 4 on effectiveness.

Pfizer’s stock has declined 25.8% this year so far compared with a decrease of 1.8% for the industry.


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GSK’s (GSK - Free Report) RSV vaccine, Arexvy, is also approved for the prevention of LRTD caused by RSV in older adults. The FDA approved the vaccine last month. This was the first RSV vaccine for older adults to be approved anywhere in the world.

GSK’s RSV vaccine is under review in Japan and Europe as well. In April, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of the vaccine. A final European regulatory decision is expected soon.

Older adults, young infants and people with some chronic medical conditions are at maximum risk to get lower respiratory tract infections (LRTI)-RSV disease. The approval of Abrysvo and Arexvy’s approval is expected to provide protection to older adults in the anticipated RSV season this fall. The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to have a meeting on Jun 21 to give its recommendation for the proper use of RSV vaccines in older adults. Pfizer expects Abrysvo to be available by the third quarter of 2023, ahead of fall.

Moderna is also developing an mRNA vaccine, mRNA-1345, targeting RSV in a phase III study, ConquerRSV, in older adults. The study met the primary efficacy endpoints, per top-line data announced in January. Based on these results, Moderna expects to file for regulatory approval. The company is also evaluating mRNA-1345 in an early-stage study in pediatric populations.

Pfizer has also developed an RSV vaccine for infants through maternal immunization. The vaccine candidate is under FDA review for preventing medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. A decision from the FDA is expected in August.

Last month, the FDA’s VRBPAC voted in favor of the RSV vaccine for infants. The committee believes the available data supports the efficacy and safety of the RSV vaccine. The committee voted 10 to 4 on safety and 14 to 0 on effectiveness. Pfizer’s RSV vaccine candidate is also under review for both older adults and maternal immunization in Europe.

AstraZeneca (AZN - Free Report) and Sanofi’s (SNY - Free Report) RSV vaccine called Beyfortus/nirsevimab was approved in Europe for protection against LRTI caused by RSV in newborns and infants in November 2022. A similar application is under review in the United States, with an FDA decision expected in the third quarter of this year.  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 hasa Zacks Rank #4 (Sell).

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