European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease
Pfizer (NYSE: PFE) has received European Commission approval for an expanded indication of its RSV vaccine ABRYSVO®. The authorization now includes prevention of lower respiratory tract disease (LRTD) in adults aged 18-59, extending beyond its previous approval for those 60 and older.
ABRYSVO becomes the first and only RSV vaccine approved in the European Union for non-pregnant adults aged 18-49. The vaccine now offers the broadest RSV indication in the EU, covering both active immunization for adults 18 and older, and passive protection for infants through maternal immunization during pregnancy.
The approval is supported by the phase 3 clinical trial MONeT (NCT05842967), which evaluated the vaccine's safety, tolerability, and immunogenicity in adults 18-59 years with risk factors for RSV-associated LRTD. RSV causes approximately 158,000 adult hospital admissions annually in the EU.
Pfizer (NYSE: PFE) ha ricevuto l'approvazione dalla Commissione Europea per un'indicazione ampliata del suo vaccino RSV ABRYSVO®. L'autorizzazione ora include la prevenzione delle malattie delle vie respiratorie inferiori (LRTD) negli adulti di età compresa tra 18 e 59 anni, estendendosi oltre la precedente approvazione per coloro di età pari o superiore a 60 anni.
ABRYSVO diventa il primo e unico vaccino RSV approvato nell'Unione Europea per adulti non in gravidanza di età compresa tra 18 e 49 anni. Il vaccino ora offre la più ampia indicazione RSV nell'UE, coprendo sia l'immunizzazione attiva per gli adulti di 18 anni e oltre, sia la protezione passiva per i neonati tramite l'immunizzazione materna durante la gravidanza.
L'approvazione è supportata dallo studio clinico di fase 3 MONeT (NCT05842967), che ha valutato la sicurezza, la tollerabilità e l'immunogenicità del vaccino negli adulti di età compresa tra 18 e 59 anni con fattori di rischio per LRTD associata a RSV. L'RSV causa circa 158.000 ricoveri ospedalieri annuali negli adulti nell'UE.
Pfizer (NYSE: PFE) ha recibido la aprobación de la Comisión Europea para una indicación ampliada de su vacuna contra el RSV ABRYSVO®. La autorización ahora incluye la prevención de enfermedades del tracto respiratorio inferior (LRTD) en adultos de 18 a 59 años, ampliándose más allá de su aprobación anterior para aquellos de 60 años o más.
ABRYSVO se convierte en la primera y única vacuna contra el RSV aprobada en la Unión Europea para adultos no embarazadas de 18 a 49 años. La vacuna ahora ofrece la indicación más amplia de RSV en la UE, cubriendo tanto la inmunización activa para adultos de 18 años en adelante, como la protección pasiva para los lactantes a través de la inmunización materna durante el embarazo.
La aprobación está respaldada por el ensayo clínico de fase 3 MONeT (NCT05842967), que evaluó la seguridad, tolerabilidad e inmunogenicidad de la vacuna en adultos de 18 a 59 años con factores de riesgo para LRTD asociada al RSV. El RSV causa aproximadamente 158,000 ingresos hospitalarios anuales en adultos en la UE.
화이자 (NYSE: PFE)는 RSV 백신 ABRYSVO®의 적응증 확대에 대해 유럽연합 집행위원회의 승인을 받았습니다. 이 승인에는 이제 18세에서 59세 성인의 하부 호흡기 질환(LRTD) 예방이 포함되어 있으며, 이전의 60세 이상에 대한 승인 범위를 넘어서게 되었습니다.
ABRYSVO는 비임신 성인을 위한 유럽연합에서 승인된 첫 번째이자 유일한 RSV 백신이 됩니다. 이 백신은 이제 18세 이상의 성인을 위한 적극적인 면역화와 임신 중 모체 면역화를 통한 영아에 대한 수동 보호를 모두 포함하여 유럽에서 가장 광범위한 RSV 적응증을 제공합니다.
이번 승인은 RSV 관련 LRTD 위험 요소를 가진 18세에서 59세 성인에서 백신의 안전성, 내약성 및 면역원성을 평가한 3상 임상시험 MONeT (NCT05842967)에 의해 뒷받침됩니다. RSV는 매년 유럽에서 약 158,000명의 성인이 병원에 입원하는 원인입니다.
Pfizer (NYSE: PFE) a reçu l'approbation de la Commission européenne pour une indication élargie de son vaccin RSV ABRYSVO®. L'autorisation inclut désormais la prévention des maladies des voies respiratoires inférieures (LRTD) chez les adultes âgés de 18 à 59 ans, dépassant ainsi son approbation précédente pour les personnes de 60 ans et plus.
ABRYSVO devient le premier et unique vaccin RSV approuvé dans l'Union européenne pour les adultes non enceintes âgés de 18 à 49 ans. Le vaccin offre désormais l'indication RSV la plus large dans l'UE, couvrant à la fois l'immunisation active pour les adultes de 18 ans et plus, et la protection passive pour les nourrissons par le biais de l'immunisation maternelle pendant la grossesse.
L'approbation est soutenue par l'essai clinique de phase 3 MONeT (NCT05842967), qui a évalué la sécurité, la tolérance et l'immunogénicité du vaccin chez les adultes de 18 à 59 ans présentant des facteurs de risque de LRTD associée au RSV. Le RSV entraîne environ 158 000 admissions hospitalières annuelles chez les adultes dans l'UE.
Pfizer (NYSE: PFE) hat die Genehmigung der Europäischen Kommission für eine erweiterte Indikation seines RSV-Impfstoffs ABRYSVO® erhalten. Die Genehmigung umfasst nun die Prävention von Erkrankungen der unteren Atemwege (LRTD) bei Erwachsenen im Alter von 18 bis 59 Jahren und geht über die vorherige Genehmigung für Personen ab 60 Jahren hinaus.
ABRYSVO wird der erste und einzige RSV-Impfstoff, der in der Europäischen Union für nicht schwangere Erwachsene im Alter von 18 bis 49 Jahren genehmigt ist. Der Impfstoff bietet nun die umfassendste RSV-Indikation in der EU, die sowohl die aktive Immunisierung für Erwachsene ab 18 Jahren als auch den passiven Schutz für Säuglinge durch mütterliche Immunisierung während der Schwangerschaft abdeckt.
Die Genehmigung stützt sich auf die klinische Phase-3-Studie MONeT (NCT05842967), die die Sicherheit, Verträglichkeit und Immunogenität des Impfstoffs bei Erwachsenen im Alter von 18 bis 59 Jahren mit Risikofaktoren für RSV-assoziierte LRTD bewertet hat. RSV verursacht jährlich etwa 158.000 Krankenhausaufenthalte bei Erwachsenen in der EU.
- First-mover advantage in EU RSV vaccine market for ages 18-49
- Broadest RSV vaccine indication coverage in EU market
- Potential revenue growth from expanded addressable market
- None.
Insights
The European Commission's expansion of ABRYSVO's indication to include adults 18-59 years old represents a significant market opportunity for Pfizer. This regulatory win creates three key advantages:
First, it establishes a first-mover advantage in the younger adult RSV vaccine segment. Being the first and only RSV vaccine approved for non-pregnant adults aged 18-49 in the EU gives Pfizer exclusive access to this demographic before competitors can enter.
Second, this creates the broadest RSV vaccine indication in the EU market, spanning all adults 18+ while also including maternal immunization to protect infants. This comprehensive coverage simplifies marketing messaging and potentially streamlines adoption across healthcare systems.
Third, with approximately 158,000 adult RSV hospitalizations annually in the EU, this expanded authorization addresses a substantial unmet medical need. The high-risk groups with chronic conditions specifically studied in the MONeT trial represent a particularly valuable target segment with clear medical necessity.
The approval timing is strategically important as it allows Pfizer to integrate this expanded indication into vaccination campaigns before the next RSV season. This expanded authorization strengthens Pfizer's respiratory vaccine portfolio at a time when the company needs growth drivers beyond COVID products.
The expanded authorization of ABRYSVO to include adults 18-59 years represents a meaningful advancement in RSV prevention strategy across the EU. RSV has long been recognized as a significant respiratory threat, but vaccination options have historically been to high-risk groups.
The public health impact could be substantial. With 158,000 annual RSV-related hospitalizations among adults in the EU, broadening protection to younger adults with underlying conditions creates a more comprehensive prevention framework. The MONeT trial's focus on adults with chronic medical conditions specifically targets those most vulnerable to severe outcomes.
What's particularly notable is the creation of a continuous protection model across age groups. ABRYSVO now offers protection for:
- Infants through maternal immunization
- At-risk adults 18-59
- Older adults 60+
This comprehensive coverage has the potential to disrupt RSV transmission chains within communities, potentially providing indirect protection even to unvaccinated individuals through reduced circulation.
From an implementation perspective, healthcare systems will need to develop clear guidelines for which 18-59 year olds should prioritize vaccination, as the MONeT trial focused specifically on those with underlying conditions. Providers will need education on identifying appropriate candidates within this newly eligible population.
- ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for non-pregnant adults aged 18-49
- Active immunization of individuals 18 years of age and older for the prevention of LRTD caused by RSV
- Passive protection against lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy
“We are thrilled that ABRYSVO is now approved in the EU to help prevent RSV in adults aged 18 and older, which causes approximately 158,000 adult hospital admissions annually from RSV disease, a common respiratory virus with symptoms that can be severe or even life-threatening,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer. “With an indication that also includes pregnant individuals between weeks 24 and 36 gestation to help protect infants from birth up to 6 months of age, ABRYSVO’s expanded authorization for adults aged 18 to 59 in the EU signifies another step for public health by offering the potential to substantially reduce the burden of RSV in future seasons.”
The amended marketing authorization follows the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states plus
ABOUT RSV
Respiratory Syncytial Virus (RSV) is a contagious virus and a common cause of respiratory illness worldwide.5 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.6,7,8 There are two major subgroups of RSV: RSV-A and RSV-B.9 Both subgroups cause disease and can co-circulate or alternate predominance from season to season. In total, RSV causes approximately 158,000 hospital admissions annually among adults aged 18 and older across the EU, with an estimated 13,000 hospitalizations in those aged 18 to 64 years.10
ABOUT ABRYSVO
ABRYSVO is an unadjuvanted, bivalent vaccine that was designed to provide 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 August 2023, Pfizer announced that the European Commission granted marketing authorization for ABRYSVO for both adults aged 60 years and older and maternal immunization to help protect infants.
In the
In addition to the most recent EU approval, ABRYSVO has received approvals for both indications in multiple countries worldwide.
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
- 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
-
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 1, 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 an approval in the EU to extend the indication to include prevention of LRTD caused by RSV in individuals 18 through 59 years of age, 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
1 Walsh EE, Falsey AR, Scott DA, et al. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366.
2 Schmoele-Thoma B, Zareba AM, Jiang Q, et al. Vaccine Efficacy in Adults in a Respiratory Syncytial Virus Challenge Study. N Engl J Med. 2022 Jun 23;386(25):2377-2386. doi: 10.1056/NEJMoa2116154.
3 Baker J, Aliabadi N, Munjal I, et al. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study. Vaccine. 2024 May 10;42(13):3172-3179. doi: 10.1016/j.vaccine.2024.03.070. Epub 2024 Apr 16.
4 Peterson JT, Zareba AM, Fitz-Patrick D, et al. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine. J Infect Dis. 2022 Jun 15;225(12):2077-2086. doi: 10.1093/infdis/jiab505.
5 World Health Organization. Respiratory Syncytial Virus (RSV) disease. https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/vaccine-standardization/respiratory-syncytial-virus-disease
6 World Health Organization. Respiratory Syncytial Virus (RSV). https://www.who.int/news-room/fact-sheets/detail/respiratory-syncytial-virus-(rsv)
7 Centers for Disease Control and Prevention. Respiratory Syncytial Virus Infection (RSV) – Older Adults are at High Risk for Severe RSV Infection Fact Sheet. https://www.cdc.gov/rsv/factsheet-older-adults.pdf
8 Centers for Disease Control and Prevention. RSV in Infants and Young Children. https://www.cdc.gov/rsv/high-risk/infants-young-children.html
9 Nuttens C, Moyersoen J, Curcio D, et al. Differences Between RSV A and RSV B Subgroups and Implications for Pharmaceutical Preventive Measures. Infect Dis Ther. 2024;13(8):1725-1742. doi:10.1007/s40121-024-01012-2
10 Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, et al. Estimation of the Number of Respiratory Syncytial Virus–Associated Hospitalizations in Adults in the European Union. J Infect Dis 2023 May 29;228(11):1539–1548. doi: 10.1093/infdis/jiad189.
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