U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease
The U.S. FDA has approved Pfizer's ABRYSVO®, a bivalent RSV prefusion F vaccine, for preventing lower respiratory tract disease (LRTD) caused by RSV in adults aged 18-59 at increased risk. This marks the first and only RSV vaccine indicated for adults under 50. The approval is based on data from the pivotal Phase 3 MONeT trial, which evaluated the vaccine's safety, tolerability, and immunogenicity. ABRYSVO also remains the sole RSV immunization approved for pregnant individuals at 32-36 weeks gestation, protecting infants up to 6 months. Pfizer aims to publish the MONeT trial results in a peer-reviewed journal and present them at an upcoming scientific conference.
La FDA degli Stati Uniti ha approvato ABRYSVO® di Pfizer, un vaccino bivalente F prefusione RSV, per prevenire le malattie delle vie respiratorie inferiori (LRTD) causate da RSV negli adulti di età compresa tra 18 e 59 anni ad alto rischio. Questo segna il primo e unico vaccino RSV indicato per gli adulti sotto i 50 anni. L'approvazione si basa su dati del trial pivotale di Fase 3 MONeT, che ha valutato la sicurezza, la tollerabilità e l'immunogenicità del vaccino. ABRYSVO rimane anche l'unica immunizzazione RSV approvata per le persone in gravidanza alle 32-36 settimane di gestazione, proteggendo i neonati fino a 6 mesi. Pfizer mira a pubblicare i risultati del trial MONeT su una rivista peer-reviewed e presentarli in una prossima conferenza scientifica.
La FDA de EE. UU. ha aprobado ABRYSVO® de Pfizer, una vacuna bivalente de F prefusión contra el RSV, para prevenir enfermedades de las vías respiratorias bajas (LRTD) causadas por RSV en adultos de 18 a 59 años en mayor riesgo. Esto marca la primera y única vacuna contra el RSV indicada para adultos menores de 50 años. La aprobación se basa en datos del ensayo crucial de Fase 3 MONeT, que evaluó la seguridad, tolerabilidad e inmunogenicidad de la vacuna. ABRYSVO también sigue siendo la única inmunización contra el RSV aprobada para personas embarazadas en las semanas 32-36 de gestación, protegiendo a los bebés hasta los 6 meses. Pfizer tiene como objetivo publicar los resultados del ensayo MONeT en una revista revisada por pares y presentarlos en una próxima conferencia científica.
미국 FDA는 RSV 예방을 위한 이중가치 F 프리퓨전 백신인 Pfizer의 ABRYSVO®를 18-59세 고위험 성인의 하부 호흡기 질환(LRTD) 예방을 위해 승인했습니다. 이는 50세 이하 성인을 위한 첫 번째이자 유일한 RSV 백신입니다. 이번 승인은 백신의 안전성, 내약성 및 면역원성을 평가한 주요 3상 MONeT 시험의 데이터를 바탕으로 합니다. ABRYSVO는 또한 임신 32-36주 여성에게 승인된 유일한 RSV 면역주사로, 최대 6개월 된 유아를 보호합니다. Pfizer는 MONeT 시험 결과를 동료 평가 저널에 발표하고 다가오는 과학 회의에서 발표할 계획입니다.
La FDA des États-Unis a approuvé ABRYSVO® de Pfizer, un vaccin bivalent à F préfusion contre le RSV, pour prévenir les maladies des voies respiratoires inférieures (LRTD) causées par le RSV chez les adultes de 18 à 59 ans à risque accru. Cela marque le premier et l'unique vaccin contre le RSV indiqué pour les adultes de moins de 50 ans. L'approbation repose sur des données de l'essai pivot de Phase 3 MONeT, qui a évalué la sécurité, la tolérance et l'immunogénicité du vaccin. ABRYSVO reste également la seule immunisation contre le RSV approuvée pour les femmes enceintes à 32-36 semaines de grossesse, protégeant ainsi les nourrissons jusqu'à 6 mois. Pfizer vise à publier les résultats de l'essai MONeT dans une revue évaluée par des pairs et à les présenter lors d'une prochaine conférence scientifique.
Die FDA der USA hat Pfizers ABRYSVO®, einen bivalenten RSV-Prefusions-F-Impfstoff, zur Prävention von Erkrankungen der unteren Atemwege (LRTD), die durch RSV bei Erwachsenen im Alter von 18 bis 59 Jahren mit erhöhtem Risiko verursacht werden, zugelassen. Dies ist der erste und einzige RSV-Impfstoff, der für Erwachsene unter 50 Jahren zugelassen ist. Die Genehmigung basiert auf den Daten der entscheidenden Phase-3-Studie MONeT, die die Sicherheit, Verträglichkeit und Immunogenität des Impfstoffs untersucht hat. ABRYSVO bleibt auch die einzige RSV-Immunisierung, die für schwangere Personen in der 32.-36. Woche der Schwangerschaft genehmigt ist und damit Säuglinge bis zu 6 Monaten schützt. Pfizer plant, die Ergebnisse der MONeT-Studie in einer begutachteten Fachzeitschrift zu veröffentlichen und sie auf einer bevorstehenden wissenschaftlichen Konferenz vorzustellen.
- FDA approval of ABRYSVO for adults aged 18-59 at increased risk expands market potential.
- First and only RSV vaccine for adults under 50, offering a competitive edge.
- ABRYSVO is also approved for pregnant individuals, protecting infants up to 6 months.
- Approval based on inferred efficacy from Phase 3 trial data, not direct evidence.
Insights
Pfizer's ABRYSVO approval for adults 18-59 at increased RSV risk is a significant advancement in preventive medicine. This expanded indication makes it the first and only RSV vaccine for adults under 50, addressing a critical gap in protection for vulnerable populations.
The approval, based on the MONeT trial, demonstrates inferred efficacy in adults with chronic conditions like COPD, diabetes and heart failure. With
Investors should note the potential for increased market share and revenue growth for Pfizer in the RSV vaccine space, given ABRYSVO's unique position and broad indication range. The upcoming publication of trial results could further solidify its clinical value and market potential.
This FDA approval significantly expands ABRYSVO's market potential, positioning Pfizer to capture a larger share of the RSV vaccine market. The broader indication for adults 18-59 at increased risk opens up a substantial new patient population, potentially driving significant revenue growth.
Investors should consider the following financial implications:
- Increased sales potential in the younger adult demographic
- Potential for higher insurance coverage and reimbursement rates due to the expanded high-risk indication
- First-mover advantage in the 18-49 age group, which could lead to market dominance
- Synergies with Pfizer's existing vaccine portfolio, potentially reducing marketing and distribution costs
While specific revenue projections aren't provided, this approval could materially impact Pfizer's vaccine segment performance and overall financial outlook in the coming years.
- First and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50
- Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower respiratory tract disease caused by RSV
“RSV represents a significant threat to younger adults with certain chronic conditions. After decades of vaccine research by the scientific community and Pfizer, we now have the opportunity to help alleviate the burden of RSV in this high-risk adult population,” said Aamir Malik, Chief
The FDA’s decision is based on inferred efficacy1 from the pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults at risk of RSV-associated disease due to certain chronic medical conditions. The company intends to submit results from MONeT for publication in a peer-reviewed scientific journal and for presentation at an upcoming scientific conference.
Among
ABOUT RSV
Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness.5 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.6,7 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.8 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. Additionally, ABRYSVO has received approvals for both indications in multiple countries worldwide.
INDICATIONS FOR ABRYSVO
ABRYSVO® is a vaccine indicated in the US for:
- 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
- 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
-
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. If it is not currently available via this link, it will be visible as soon as possible as we work to finalize the document. Please check back for the full information shortly.
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 October 22, 2024. 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 an approval in the
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, 2023, 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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REFERENCES
1 Fink D. Immunobridging to Evaluate Vaccines. https://cdn.who.int/media/docs/default-source/blue-print/doran-fink_4_immunobridging_vrconsultation_6.12.2021.pdf. Published June 2021, Accessed October 2024
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3 Weycker, D., Averin, A., Houde, L. et al. Rates of Lower Respiratory Tract Illness in US Adults by Age and Comorbidity Profile. Infect Dis Ther 2024;13: 207–220. doi: 10.1007/s40121-023-00904-z. Epub 2024 Jan 18. PMID: 38236516; PMCID: PMC10828164.
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5 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 October 2024.
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Category: Vaccines
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FAQ
What is ABRYSVO®?
What age group is ABRYSVO® approved for?
What was the basis for ABRYSVO®'s FDA approval?
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