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Pfizer and GSK Head on Fight for First FDA-Approved RSV Vaccine

Gauri Kurdukar March 3, 2023

The two leading companies in vaccine production are almost at the finish line for the world’s first adult RSV vaccine. The FDA’s approval decision is expected in May 2023. Pfizer announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to support its RSV vaccine for older adults on other hand just a day after Pfizer’s declaration; GSK shared similar news for its RSV vaccine, AREXVY.

The First adult RSV Vaccine:

RSV is a common respiratory virus that causes mild cold-like symptoms. In some serious cases, RSV infection spread to the lower respiratory tract which leads to pneumonia or bronchitis. Some people recover very quickly due to higher immunity power but in infants and older adults, the immunity power is comparatively. So there might be a chance to suffer prolonged RSV infection.

The recent advancement in technology has encouraged many companies to showcase their talent and bring an adult vaccine to table. The recent VRBPAC vote might drive GSK’s vaccine past the finish line before its competitors.
The advisory committee is formed for the delivery of non-binding recommendations for the FDA, voted unanimously 12-0 on the effectiveness and 10-2 on the safety of GSK’s vaccine. In contrast, VRBPAC voted 7-4 with one abstention for both the safety and efficacy of Pfizer’s RSV vaccine, ABRYSVO. The FDA granted GSK’s RSV vaccine Priority Review and assigned a Prescription Drug User Fee Act action date of May 3.

Some old and new discoveries:
In November 2022, Sanofi and AstraZeneca made historical approval of its RSV vaccine, Beyfortus, which is designed to prevent the disease in infants and young children. But for now, only the European Medicines Agency is having the approval for the drug, with the FDA still waiting to render a decision on the vaccine. Other than Pfizer and GSK, companies including Moderna, Janssen, and Novavax have RSV vaccines in Phase 3 trials. Still, it seems like either GSK or Pfizer’s RSV vaccines will hold the title for the first FDA-approved RSV vaccine.