They also recommended RSV immunisation for adults aged 60-74 who are at increased risk for severe RSV disease. These recommendations replace the previous recommendation for shared clinical decision-making in these age groups, and have the potential to positively impact access to RSV immunization, particularly for the estimated 23 million US adults aged 75 and older.1
ACIP postponed a vote on a recommendation for adults aged 50-59 at increased risk for RSV-LRTD until additional data become available. GSK continues to generate data, building on the existing robust clinical data package, to help inform future policy decision-making. Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) is the first and only vaccine FDA-approved for adults aged 50-59 who are at increased risk for RSV-LRTD, approved
Over 13 million US adults aged 50-59 have at least one known medical condition that increases their risk for severe RSV outcomes.2 Each year, RSV is estimated to cause approximately 42,000 hospitalisations in adults aged 50-64 years.3
In making its recommendations, the ACIP evaluated available efficacy and immunogenicity data on each licensed RSV vaccine for adults and considered the latest real-world surveillance data from the FDA and
The ACIP recommendations will be forwarded to the director of the
About GSK's RSV Vaccine
Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK's proprietary AS01E adjuvant.
In
The vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in over 40 countries. Regulatory reviews for both the use of the vaccine in individuals 60 years of age and older and those aged 50-59 at increased risk are ongoing in multiple countries. The proposed trade name remains subject to regulatory approval in other markets.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from
About RSV in adults
RSV is a common contagious virus affecting the lungs and breathing passages. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.4 Each year, RSV is estimated to cause approximately 177,000 hospitalisations in adults 65 years and older5 and 42,000 in adults aged 50-64 years old in the US.3
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2022, and Q1 Results for 2024.
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