PHILADELPHIA - GSK plc (LSE/NYSE: LON:GSK) has announced that the US Food and Drug Administration (FDA) is reviewing an application for the extension of their adjuvanted respiratory syncytial virus (RSV) vaccine, currently approved for adults over 60, to include adults aged 50-59 with increased risk for RSV disease. This follows positive results from a phase III trial assessing the immune response and safety of the vaccine in this age group, particularly those with underlying medical conditions.
The FDA has granted Priority Review to the application, which could make GSK's vaccine the first available for RSV prevention in the 50-59 age bracket. The Prescription Drug User Fee Act action date, by which the FDA will make its decision, is set for June 7, 2024.
RSV is a significant cause of respiratory illness in older adults and can lead to severe complications, especially in those with conditions like chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure. The phase III trial, [NCT05590403]4, compared immune responses in adults aged 50-59 with chronic diseases to those aged 60 and older, aiming to demonstrate non-inferiority.
The RSV vaccine by GSK, known as AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted), includes the recombinant glycoprotein F stabilized in the prefusion conformation (RSVPreF3) and the proprietary AS01E adjuvant. It is contraindicated for individuals with severe allergic reactions to any vaccine component and requires medical supervision to manage potential anaphylactic reactions post-administration.
The vaccine's approval and use in the proposed age group would be in accordance with official recommendations. While the vaccine is designed to elicit a protective immune response, it may not do so in all recipients. The most common adverse reactions reported include injection site pain, fatigue, myalgia, headache, and arthralgia.
The trial results will be presented at forthcoming medical conferences and are being submitted to other regulatory bodies to support potential label expansions.
This information is based on a press release statement from GSK.
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