2023-03-03| Trials & Approvals

Pfizer and GSK Neck and Neck for First FDA-Approved RSV Vaccine

by Reed Slater
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One day after Pfizer announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to support its RSV vaccine for older adults, GSK shared similar good news for its RSV vaccine candidate, AREXVY. The two companies are leading the pack to the finish line for the world’s first adult RSV vaccine, with both products’ FDA approval decisions expected in May. 

The Quest for the First Adult RSV Vaccine

Human respiratory syncytial virus (RSV) is a common respiratory illness most often affecting infants and young children. However, older adults, particularly immunocompromised individuals, are at risk of contracting RSV and developing life-threatening symptoms. 

With decades of development in the RSV vaccine development, recent advancements in technology have encouraged several companies to bring out their best talent to bring an adult vaccine to the table, with GSK near the front of the pack. The recent VRBPAC vote might drive GSK’s vaccine past the finish line before its competitors. 

The advisory committee, formed to deliver 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. Less definitive but just as competitive, Pfizer said it expects an FDA decision sometime in May. 

Related Article: Pfizer’s RSV Vaccine Wins Support From FDA Advisory Panel for Use in Older Adults

The RSV Vaccine’s Present and Future

In November last year, Sanofi and AstraZeneca made waves with the historical approval of its RSV vaccine, Beyfortus, designed to prevent the disease in infants and young children. So far, only the European Medicines Agency has approved the drug, with the FDA still waiting to render a decision on the vaccine. 

In the older adult space, several companies are bringing their best talent forward in hopes of gaining historic approval in the space. Besides Pfizer and GSK, companies including Moderna, Janssen, and Novavax have RSV vaccines in Phase 3 trials. 

Still, with VRBPAC’s most recent votes on GSK and Pfizer’s RSV vaccines, it seems like one of the two companies will hold the title for the first FDA-approved RSV vaccine in the coming months. With an edge in safety and efficacy votes, GSK’s AREXVY, from the outside, looking in, appears to be the more likely candidate of the two. Time will tell, though, and an update on the world’s first FDA-approved RSV vaccine will come in May.

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