RSV Vaccine Supply Un-Constrained

Reuters recently confirmed GSK plc expects to launch its respiratory syncytial virus (RSV) vaccine in the U.S. in 2023 without supply constraints.

"We are ready to launch without capacity or supply constraints... to supply the market (from its plant in Wavre, Belgium) that we see," Phil Dormitzer, Global Head of Vaccines R&D at GSK, commented in an interview on March 8, 2023.

GSK plc previously announced that the U.S. Food and Drug Administration (FDA) vaccine voted that the available data support the safety and effectiveness of GSK's AREXVY™ vaccine candidate for preventing lower respiratory tract disease caused by RSV in adults aged 60 years and older.

The FDA Committee voted unanimously 12-0 on effectiveness and 10-2 on safety.

As of March 10, 2023, the FDA has yet to authorize AREXVY for use in the U.S.

Phil Dormitzer commented in a press release on March 1, 2023, "Today's vote brings us an important step closer to delivering one of the world's first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems."

AREXVY is also under regulatory review by the European Medicines Agency, Japan's Ministry of Health, Labour and Welfare, and several other regulators, with initial decisions expected later in 2023. 

RSV is one of the major remaining infectious diseases for which no vaccine or specific treatment is available for adults. Older adults are at high risk for severe disease due in part to age-related decline in immunity,

Additionally, RSV is a very serious disease in young children.

Unlike seniors, children already have FDA-approved RSV protection from a monoclonal antibody (Synagis®), with another version under final review.

The European Medicines Agency recommended marketing authorization for Beyfortus® (nirsevimab) in 2022 to prevent RSV lower respiratory tract disease in infants during their first RSV season when there is a risk of RSV infection in the local community.

Additional RSV vaccine candidates and antibody therapy news are posted at PrecisionVaccinations.com/RSV.