ACIP Votes to Expand Recommendation for Pfizer’s RSV Vaccine ABRYSVO® to Include Adults Aged 50 to 59 at Increased Risk of Disease
Pfizer (PFE) announced that the CDC's Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for RSV vaccines to include adults aged 50-59 at increased risk of RSV-associated lower respiratory tract disease (LRTD). This expansion specifically includes ABRYSVO®, which received FDA approval in October 2024 for preventing RSV-associated LRTD in at-risk adults aged 18-59.
According to CDC data, approximately 15,000-20,000 RSV-associated hospitalizations occur annually in U.S. adults aged 50-59. The highest risk affects those with underlying conditions such as obesity, cardiovascular disease, diabetes, COPD, asthma, and other chronic or immunocompromising conditions. ABRYSVO currently holds the broadest indication among RSV vaccines, covering older adults, at-risk adults 18 and older, and pregnant women.
Pfizer (PFE) ha annunciato che il Comitato Consultivo per le Pratiche di Immunizzazione (ACIP) dei CDC ha votato per ampliare la sua raccomandazione sui vaccini contro il RSV includendo gli adulti di età compresa tra 50 e 59 anni a rischio aumentato di malattie delle vie respiratorie inferiori associate al RSV (LRTD). Questa estensione riguarda specificamente ABRYSVO®, che ha ricevuto l'approvazione della FDA nell'ottobre 2024 per la prevenzione della LRTD associata al RSV negli adulti a rischio di età compresa tra 18 e 59 anni.
Secondo i dati dei CDC, ogni anno negli Stati Uniti si registrano circa 15.000-20.000 ricoveri per RSV in adulti tra i 50 e i 59 anni. Il rischio maggiore riguarda persone con condizioni preesistenti come obesità, malattie cardiovascolari, diabete, BPCO, asma e altre patologie croniche o immunodepressive. ABRYSVO attualmente detiene l'indicazione più ampia tra i vaccini RSV, coprendo anziani, adulti a rischio dai 18 anni in su e donne in gravidanza.
Pfizer (PFE) anunció que el Comité Asesor sobre Prácticas de Inmunización (ACIP) de los CDC votó para ampliar su recomendación sobre las vacunas contra el VRS para incluir a adultos de 50 a 59 años con mayor riesgo de enfermedad respiratoria baja asociada al VRS (LRTD). Esta ampliación incluye específicamente a ABRYSVO®, que recibió la aprobación de la FDA en octubre de 2024 para prevenir la LRTD asociada al VRS en adultos en riesgo de 18 a 59 años.
Según datos de los CDC, aproximadamente entre 15,000 y 20,000 hospitalizaciones asociadas al VRS ocurren anualmente en adultos estadounidenses de 50 a 59 años. El mayor riesgo afecta a quienes tienen condiciones subyacentes como obesidad, enfermedades cardiovasculares, diabetes, EPOC, asma y otras condiciones crónicas o que comprometen el sistema inmunitario. ABRYSVO actualmente tiene la indicación más amplia entre las vacunas contra el VRS, cubriendo a adultos mayores, adultos en riesgo de 18 años en adelante y mujeres embarazadas.
화이자(Pfizer, PFE)는 CDC의 예방접종자문위원회(ACIP)가 RSV 백신 권고 범위를 RSV 관련 하부 호흡기 질환(LRTD) 위험이 높은 50-59세 성인으로 확대하기로 투표했다고 발표했습니다. 이 확대 권고에는 2024년 10월 FDA 승인을 받은 ABRYSVO®가 포함되며, 이는 18-59세 고위험 성인의 RSV 관련 LRTD 예방을 위한 것입니다.
CDC 데이터에 따르면 미국 내 50-59세 성인 중 매년 약 15,000~20,000건의 RSV 관련 입원이 발생합니다. 가장 높은 위험군은 비만, 심혈관 질환, 당뇨병, 만성폐쇄성폐질환(COPD), 천식 및 기타 만성 또는 면역 저하 상태를 가진 사람들입니다. ABRYSVO는 현재 RSV 백신 중 가장 넓은 적응증을 가지고 있으며, 노인, 18세 이상 고위험 성인, 임산부를 포함합니다.
Pfizer (PFE) a annoncé que le Comité consultatif sur les pratiques d'immunisation (ACIP) des CDC a voté pour étendre sa recommandation concernant les vaccins contre le VRS aux adultes âgés de 50 à 59 ans présentant un risque accru de maladie des voies respiratoires basses associée au VRS (LRTD). Cette extension inclut spécifiquement ABRYSVO®, qui a reçu l'approbation de la FDA en octobre 2024 pour la prévention de la LRTD associée au VRS chez les adultes à risque âgés de 18 à 59 ans.
Selon les données des CDC, environ 15 000 à 20 000 hospitalisations liées au VRS surviennent chaque année chez les adultes américains de 50 à 59 ans. Le risque le plus élevé concerne les personnes atteintes de maladies sous-jacentes telles que l'obésité, les maladies cardiovasculaires, le diabète, la BPCO, l'asthme et d'autres affections chroniques ou immunodéprimées. ABRYSVO détient actuellement l'indication la plus large parmi les vaccins contre le VRS, couvrant les personnes âgées, les adultes à risque de 18 ans et plus, ainsi que les femmes enceintes.
Pfizer (PFE) gab bekannt, dass das Beratungskomitee für Immunisierungspraktiken (ACIP) der CDC dafür gestimmt hat, die Empfehlung für RSV-Impfstoffe auf Erwachsene im Alter von 50 bis 59 Jahren mit erhöhtem Risiko für RSV-assoziierte untere Atemwegserkrankungen (LRTD) auszuweiten. Diese Erweiterung umfasst speziell ABRYSVO®, das im Oktober 2024 von der FDA zur Vorbeugung von RSV-assoziierten LRTD bei gefährdeten Erwachsenen im Alter von 18 bis 59 Jahren zugelassen wurde.
Nach Angaben der CDC kommt es in den USA jährlich zu etwa 15.000 bis 20.000 RSV-assoziierten Krankenhausaufenthalten bei Erwachsenen im Alter von 50 bis 59 Jahren. Das höchste Risiko besteht bei Personen mit Grunderkrankungen wie Fettleibigkeit, Herz-Kreislauf-Erkrankungen, Diabetes, COPD, Asthma und anderen chronischen oder immungeschwächten Zuständen. ABRYSVO besitzt derzeit die breiteste Indikation unter den RSV-Impfstoffen und deckt ältere Erwachsene, gefährdete Erwachsene ab 18 Jahren sowie Schwangere ab.
- FDA approval for expanded market with adults aged 18-59 at risk of severe disease
- Broadest indication coverage among RSV vaccines in the market
- Large addressable market with 15,000-20,000 annual RSV hospitalizations in 50-59 age group
- Pending final approval from CDC director and Department of Health and Human Services
- to high-risk population in 50-59 age group rather than universal recommendation
Insights
ACIP recommendation expands ABRYSVO's market to high-risk adults 50-59, potentially boosting Pfizer's competitive position in RSV prevention.
The ACIP's vote to expand recommendations for Pfizer's ABRYSVO to include at-risk adults aged 50-59 represents a meaningful market expansion for the company's RSV vaccine franchise. This recommendation follows the October 2024 FDA approval and targets a substantial population with 15,000-20,000 RSV-associated hospitalizations annually in this age group.
This development strengthens Pfizer's competitive positioning in the growing RSV vaccine market. ABRYSVO now possesses what the company describes as "the broadest indication among RSV vaccines" - covering older adults, at-risk adults 18+, and pregnant women for infant protection. This comprehensive coverage creates a distinct market advantage against competitors.
The expansion specifically targets adults with underlying conditions that elevate RSV risk, including obesity, cardiovascular disease, diabetes, COPD, asthma, and immunocompromising conditions. This targeted approach aligns with value-based care models by focusing prevention efforts on high-risk populations where vaccination delivers maximum clinical and economic benefits.
While the recommendation still requires final CDC Director and HHS approval, this regulatory milestone should enhance insurance coverage and healthcare provider adoption, facilitating greater market penetration. The recommendation adds another commercial asset to Pfizer's vaccine portfolio at a time when the company is working to diversify revenue streams beyond COVID-19 products.
- Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74
According to the CDC, between 15,000 - 20,000 RSV-associated hospitalizations occur annually in
- ACIP recommends adults 50–59 years of age who are at increased risk of severe RSV disease receive a single dose of RSV vaccine.
“With its vote to expand adult RSV vaccination recommendations, ACIP has taken an important step toward protecting individuals aged 50 to 59 who have underlying medical conditions that increase their risk for severe RSV illness,” said Alejandro Cane, Vice President, Vaccines and Antivirals
The updated ACIP recommendation, which lowers the recommended age for RSV vaccination from 60 to 50 for high-risk adults, is pending final approval by the director of the CDC and the Department of Health and Human Services.
ABOUT RSV
Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness.2 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.3,4 Chronic cardiovascular disease, chronic lung disease, moderate or severe immune compromise, diabetes with complications, and severe obesity are among the conditions that increase an individual’s risk for severe RSV.5 There are two major subgroups of RSV: RSV-A and RSV-B. Both subgroups cause disease and can co-circulate or alternate predominance from season to season.
ABOUT ABRYSVO
Pfizer currently is the only company with an RSV vaccine to help protect adults aged 60 and older, and adults 18 and older at increased risk of lower respiratory tract disease caused by RSV (RSV-LRTD), as well as infants through maternal immunization. ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide broad protection against RSV-LRTD, regardless of the virus subgroup. In the prefusion state, the RSV fusion protein (F) is a major target of neutralizing antibodies, serving as the basis of Pfizer’s RSV vaccine. Variations in the F protein sequence among RSV-A and RSV-B subgroups are clustered in a key antigenic site, a target for potent neutralizing antibodies.
In May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. In June 2024, the Advisory Committee on Immunization Practices (ACIP) voted to update its recommendation of RSV vaccines for use in adults aged ≥75 years and adults age 60-74 years who are increased risk for severe RSV disease. In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. This was followed in September 2023 with ACIP’s recommendation for maternal immunization to help protect newborns from RSV seasonally where the vaccine should be administered from September through January in most of the continental
Also in August 2023, Pfizer announced that the European Commission granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants, and in March 2025 announced the amended marketing authorization to extend the indication to include a broader adult population. Additionally, ABRYSVO has received approvals for both indications in multiple countries worldwide.
INDICATIONS FOR ABRYSVO
ABRYSVO® is a vaccine indicated in the
- the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
- the prevention of LRTD caused by RSV in people 18 through 59 years of age who are at increased risk for LRTD caused by RSV
- pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age
IMPORTANT SAFETY INFORMATION FOR ABRYSVO
- ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
- An increased risk of Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination with ABRYSVO
- For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
- Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting
- Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
- Vaccination with ABRYSVO may not protect all people
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In adults 60 years of age and older, the most common side effects (≥
10% ) were fatigue, headache, pain at the injection site, and muscle pain -
In adults 18 through 59 years of age, the most common side effects (≥
10% ) were pain at the injection site, muscle pain, joint pain and nausea -
In pregnant individuals, the most common side effects (≥
10% ) were pain at the injection site, headache, muscle pain, and nausea -
In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (
5.1% ABRYSVO versus4.4% placebo) and jaundice (7.2% ABRYSVO versus6.7% placebo)
View the full ABRYSVO Prescribing Information.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE:
The information contained in this release is as of April 16, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about ABRYSVO, including its potential benefits and a vote by ACIP to expand its recommendation to include adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of ABRYSVO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in particular jurisdictions for ABRYSVO for any potential indications; whether and when any applications that may be pending or filed for ABRYSVO may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether ABRYSVO for any such indications will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRYSVO; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities regarding ABRYSVO and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the
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2 World Health Organization. Respiratory Syncytial Virus (RSV) disease. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/vaccine-standardization/respiratory-syncytial-virus-disease. Accessed February 2025.
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FAQ
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