FDA Fuels Respiratory Syncytial Virus Vaccine Race While Backing GSK's Candidate Soon After Pfizer's
BY Benzinga — 6:15 AM ET 03/02/2023
The FDA's Vaccines and Related Biological Products Advisory Committee voted that GSK plc's NYSE:GSK available data support the safety and effectiveness of its respiratory syncytial virus (RSV) candidate to prevent lower respiratory tract disease in adults aged 60 years and older.
The vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease, meeting the trial's primary endpoint.
The Committee voted unanimously 12-0 on effectiveness and 10-2 on safety.
In November 2022, the FDA accepted the marketing application for GSK's RSV older adult vaccine candidate under Priority Review and assigned a Prescription Drug User Fee Act action date of 3 May 2023.
GSK's RSV older adult vaccine candidate is also under regulatory review by the European Medicines Agency, Japan's Ministry of Health, Labour and Welfare, and several other regulators, with decisions expected in 2023.
Pfizer Inc NYSE:PFE and GSK are running a tight race to tap into the RSV vaccine market. Analysts say the market is estimated to be over $5 billion and could exceed $10 billion by 2030, Reuters reported.
Just yesterday, VRBPAC voted 7 to 4 on safety and 7 to 4 on effectiveness, favoring Pfizer's RSV bivalent vaccine candidate.
There is currently no approved vaccine to prevent lower respiratory tract disease caused by RSV in older adults.
If approved, Guggenheim analyst estimates peak sales for the GSK vaccine to be about $2.8 billion globally.
Price Action: GSK shares are down 0.18% at $34.20 during the premarket session on the last check Thursday.
