AREXVY recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices
GSK's AREXVY vaccine has received a positive recommendation from the Advisory Committee on Immunization Practices (ACIP) for adults aged 50-59 who are at increased risk for severe RSV disease. This expands the previous recommendation from June 2024 for adults aged 60-74 at increased risk and all adults 75+.
The recommendation targets over 13 million adults aged 50-59 with conditions like COPD, asthma, diabetes, heart disease, and those in residential care. RSV causes an estimated 42,000 hospitalizations annually in adults aged 50-64 in the US.
The recommendation follows positive results from a phase III trial evaluating immune response and safety in adults aged 50-59 with underlying medical conditions. AREXVY is indicated for preventing lower respiratory tract disease caused by RSV in individuals 60+ years and those 50-59 years at increased risk.
Il vaccino AREXVY di GSK ha ricevuto una raccomandazione positiva dal Comitato Consultivo sulle Pratiche di Immunizzazione (ACIP) per gli adulti di età compresa tra 50 e 59 anni con un rischio aumentato di malattia grave da RSV. Ciò amplia la precedente raccomandazione di giugno 2024 per gli adulti dai 60 ai 74 anni a rischio e per tutti gli adulti oltre i 75 anni.
La raccomandazione riguarda oltre 13 milioni di adulti tra i 50 e i 59 anni con condizioni come BPCO, asma, diabete, malattie cardiache e coloro che vivono in strutture residenziali. Il RSV causa circa 42.000 ricoveri ospedalieri ogni anno negli adulti tra i 50 e i 64 anni negli Stati Uniti.
La raccomandazione segue i risultati positivi di uno studio di fase III che ha valutato la risposta immunitaria e la sicurezza negli adulti 50-59 anni con patologie sottostanti. AREXVY è indicato per la prevenzione delle malattie delle vie respiratorie inferiori causate da RSV in persone di 60 anni e oltre e in quelle tra i 50 e i 59 anni a rischio aumentato.
La vacuna AREXVY de GSK ha recibido una recomendación positiva del Comité Asesor sobre Prácticas de Inmunización (ACIP) para adultos de 50 a 59 años con mayor riesgo de enfermedad grave por RSV. Esto amplía la recomendación previa de junio de 2024 para adultos de 60 a 74 años con riesgo aumentado y para todos los adultos mayores de 75 años.
La recomendación abarca a más de 13 millones de adultos de 50 a 59 años con condiciones como EPOC, asma, diabetes, enfermedades cardíacas y aquellos en residencias. El RSV provoca un estimado de 42,000 hospitalizaciones anuales en adultos de 50 a 64 años en EE. UU.
La recomendación se basa en resultados positivos de un ensayo de fase III que evaluó la respuesta inmune y la seguridad en adultos de 50 a 59 años con condiciones médicas subyacentes. AREXVY está indicado para prevenir enfermedades del tracto respiratorio inferior causadas por RSV en personas de 60 años o más y en aquellas de 50 a 59 años con mayor riesgo.
GSK의 AREXVY 백신이 50-59세 성인 중 RSV 중증 질환 위험이 높은 사람들을 대상으로 한 예방접종자문위원회(ACIP)의 긍정적인 권고를 받았습니다. 이는 2024년 6월에 60-74세 고위험 성인과 75세 이상 모든 성인을 대상으로 한 이전 권고를 확대하는 것입니다.
이 권고는 만성폐쇄성폐질환(COPD), 천식, 당뇨병, 심장병 등 질환이 있거나 요양시설에 거주하는 50-59세 성인 1,300만 명 이상을 대상으로 합니다. RSV는 미국에서 50-64세 성인 연간 약 42,000건의 입원을 유발합니다.
이 권고는 기저 질환이 있는 50-59세 성인의 면역 반응과 안전성을 평가한 3상 임상시험의 긍정적인 결과를 바탕으로 합니다. AREXVY는 60세 이상 및 50-59세 고위험군에서 RSV로 인한 하부 호흡기 질환 예방에 적응증이 있습니다.
Le vaccin AREXVY de GSK a reçu une recommandation positive du Comité consultatif sur les pratiques d'immunisation (ACIP) pour les adultes âgés de 50 à 59 ans présentant un risque accru de maladie grave à RSV. Cela étend la recommandation précédente de juin 2024 pour les adultes de 60 à 74 ans à risque accru ainsi que pour tous les adultes de 75 ans et plus.
La recommandation concerne plus de 13 millions d'adultes âgés de 50 à 59 ans présentant des affections telles que la BPCO, l'asthme, le diabète, les maladies cardiaques, ainsi que ceux en établissement résidentiel. Le RSV est responsable d'environ 42 000 hospitalisations annuelles chez les adultes de 50 à 64 ans aux États-Unis.
Cette recommandation fait suite à des résultats positifs d'un essai de phase III évaluant la réponse immunitaire et la sécurité chez les adultes de 50 à 59 ans présentant des conditions médicales sous-jacentes. AREXVY est indiqué pour la prévention des maladies des voies respiratoires inférieures causées par le RSV chez les personnes de 60 ans et plus, ainsi que chez celles de 50 à 59 ans à risque accru.
Der AREXVY-Impfstoff von GSK hat eine positive Empfehlung vom Beratungsausschuss für Immunisierungspraxis (ACIP) für Erwachsene im Alter von 50 bis 59 Jahren erhalten, die ein erhöhtes Risiko für schwere RSV-Erkrankungen haben. Dies erweitert die vorherige Empfehlung vom Juni 2024 für Erwachsene im Alter von 60 bis 74 Jahren mit erhöhtem Risiko sowie für alle Erwachsenen ab 75 Jahren.
Die Empfehlung richtet sich an über 13 Millionen Erwachsene im Alter von 50 bis 59 Jahren mit Erkrankungen wie COPD, Asthma, Diabetes, Herzerkrankungen und Personen in Pflegeeinrichtungen. RSV verursacht schätzungsweise 42.000 Krankenhausaufenthalte jährlich bei Erwachsenen im Alter von 50 bis 64 Jahren in den USA.
Die Empfehlung basiert auf positiven Ergebnissen einer Phase-III-Studie, die die Immunantwort und Sicherheit bei Erwachsenen im Alter von 50 bis 59 Jahren mit Grunderkrankungen bewertete. AREXVY ist zur Vorbeugung von durch RSV verursachten unteren Atemwegserkrankungen bei Personen ab 60 Jahren sowie bei 50- bis 59-Jährigen mit erhöhtem Risiko zugelassen.
- Expanded market potential with 13 million additional eligible patients aged 50-59
- Positive ACIP recommendation strengthens market position
- Successfully demonstrated vaccine efficacy in Phase III trial
- to high-risk individuals in 50-59 age group, not general population
Insights
ACIP recommendation expands AREXVY's eligible population by 13+ million adults, strengthening GSK's RSV vaccine market position and revenue potential.
The ACIP's recommendation to include at-risk adults aged 50-59 for GSK's AREXVY represents a significant market expansion for this RSV vaccine. This broadens the eligible population by over 13 million Americans with conditions like COPD, asthma, diabetes, and heart disease who face elevated RSV risks.
This recommendation carries substantial weight as ACIP guidelines typically drive insurance coverage decisions, effectively removing a critical barrier to commercial adoption. The market opportunity is underscored by data showing RSV causes approximately 42,000 hospitalizations annually in adults aged 50-64 in the US.
The expansion follows GSK's successful phase III trial demonstrating positive immune response and safety in this younger demographic. While the recommendation still requires final approval, this development creates a clear pathway for GSK to capitalize on unmet medical needs in a younger but vulnerable population.
The commercial significance extends beyond simple patient number expansion. Adults with underlying conditions often require greater healthcare interventions when infected with RSV, creating a compelling cost-effectiveness argument for preventative vaccination. This recommendation strengthens AREXVY's position in the competitive RSV vaccine landscape and supports GSK's vaccine division revenue growth strategy through indication expansion.
This ACIP recommendation represents a meaningful public health advancement by extending RSV vaccine protection to a younger but vulnerable demographic. The clinical rationale is compelling given the 42,000 annual hospitalizations in the 50-64 age group and the exacerbation risks for those with underlying conditions.
The recommendation follows a standard evidence-based approach, utilizing phase III immunogenicity and safety data that bridges efficacy findings from older populations. This regulatory pathway is well-established for vaccines when direct efficacy studies in every subpopulation aren't feasible.
From a health economics perspective, targeting high-risk groups in the 50-59 range optimizes resource allocation by focusing immunization efforts where they'll have maximum impact. The specified conditions (COPD, asthma, diabetes, heart disease) align with established clinical risk factors for severe RSV outcomes.
Implementation will likely follow the standard post-recommendation process: incorporation into immunization schedules, followed by updated coverage policies from public and private insurers. Healthcare systems will need to develop identification mechanisms for these at-risk patients, potentially leveraging existing chronic disease management frameworks.
This expansion reflects a growing recognition of RSV's impact across the adult lifespan, not just in seniors, and signals a more nuanced approach to adult immunization based on risk stratification rather than age alone.
- Over 13 million adults aged 50-59 at increased risk in the US can potentially benefit from RSV immunization1
- RSV causes an estimated 42,000 hospitalizations* each year in adults aged 50-64 years old in the US2
A systematic review of studies in the US shows that RSV is estimated to cause 42,000 hospitalizations* each year in adults aged 50-64 years old.2 Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from severe consequences from an RSV infection compared to those without these conditions.4,5 RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.5
Tony Wood, Chief Scientific Officer, GSK: “We are pleased with ACIP's recommendation to expand the benefits of RSV immunization to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus. RSV can have a significant impact for those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination.”
In making its recommendation, the ACIP considered positive results from a phase III trial [NCT05590403]6 evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions compared to older adults aged 60 years and older where efficacy has been demonstrated after a single dose of GSK’s RSV vaccine.
The ACIP recommendations will be forwarded for review and approval. Once approved, the final recommendations will be published to advise healthcare providers on appropriate use of the vaccine and to inform insurance coverage.
About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)
AREXVY contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.
The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in 61 countries, including
The use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.
Indication for AREXVY
AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:
- Individuals 60 years of age and older;
- Individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.
Important Safety Information for AREXVY
- AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY
- The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY
- Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY
- Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting
- Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY
-
In adults 60 years of age and older, the most commonly reported adverse reactions (≥
10% ) were injection site pain (60.9% ), fatigue (33.6% ), myalgia (28.9% ), headache (27.2% ), and arthralgia (18.1% ) -
In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥
10% ) were injection site pain (75.8% ), fatigue (39.8% ), myalgia (35.6% ), headache (31.7% ), arthralgia (23.4% ), erythema (13.2% ), and swelling (10.4% ) - There are no data on the use of AREXVY in pregnant or breastfeeding individuals. AREXVY is not approved for use in persons <50 years of age
- Vaccination with AREXVY may not result in protection of all vaccine recipients
Please see full Prescribing Information for AREXVY.
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.5 RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.5 Each year, RSV is estimated to cause approximately 177,000 hospitalizations in adults 65 years and older7 and 42,000* in adults aged 50-64 years old in the US.2
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
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 in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024.
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References |
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* adjusted for under-detection |
1 Horn et al, “Disparities in Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States”, Abstract presented at National Foundation for Infectious Diseases – 27 Annual Conference on Vaccinology Research – NFID 2024; May 8-10, 2024 |
2 McLaughlin JM et al, “Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis” in Open Forum Infectious Diseases, Volume 9, Issue 7, July 2022 |
3 Centers for Disease Control and Prevention (CDC), RSV vaccine guidance for older adults, August 2024. Available at: https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/older-adults.html (Accessed April 2025) |
4 Branche AR et al., "Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020” in Clinical Infectious Diseases, 2022:74:1004–1011 |
5 Centers for Disease Control and Prevention (CDC), RSV in Adults. Available at: https://www.cdc.gov/rsv/older-adults/index.html - accessed in April 2025 |
6 M. |
7 Falsey, AR et al. “Respiratory syncytial virus infection in elderly and high-risk adults”, in New Engl J Med 2005; 352:1749-59 |
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