The U.S. Food and Drug Administration has authorized the respiratory syncytial virus (RSV) vaccine manufactured by GSK Plc.
It is the first shot to be approved for protection against a common respiratory disease that can be fatal in the elderly, the British drugmaker announced on Wednesday. According to the company, the Arexvy vaccine has been approved for people aged 60 and older.
GSK Approved For RSV Vaccine Development
The approval makes GSK, which has been competing with Pfizer in RSV vaccine development, the first company to enter a multi-billion-dollar market and places it ahead of competitors including Moderna Inc and Bavarian Nordic.
By 2030, analysts anticipate that the market for RSV vaccines will exceed $10 billion. Analysts at Credit Suisse anticipate peak sales of $2.5 billion for GSK’s RSV vaccine for older adults.
Prior to approval, GSK’s Chief Commercial Officer, Luke Miels, stated that the company anticipates the vaccine will be commercially available before the next RSV season in the United States.
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RSV Season Typically Runs From June To November
Miels stated that the vaccine would cost more than $120 per injection if a forthcoming study demonstrates that it provides protection for two RSV seasons.
The most recent RSV season began in June and peaked in November, according to the Centers for Disease Control and Prevention (CDC).
The question of how frequently the vaccine should be administered will be presented to the CDC’s immunization advisory panel. A spokesman for the CDC said that the RSV vaccination would likely be discussed at the upcoming meeting of the panel in late June.
According to government estimates, RSV causes 14,000 deaths in adults aged 65 and older in the United States annually.
In its late-stage trial, the GSK vaccine demonstrated an overall efficacy of 82.6% and was approximately 94% effective against severe lower respiratory tract disease associated with an RSV infection in participants aged 60 and older.
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