European Commission Approves Pfizer's RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease

  • ABRYSVO is the first and only RSV vaccine approved in the European Union (EU) for non-pregnant adults aged 18-49

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO ® , the company's bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes:

  • 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 Iceland, Liechtenstein, and Norway. The approval is based on results from the pivotal phase 3 clinical trial ( NCT05842967 ) MONeT (RSV I M munizati ON Study for Adul T s at Higher Risk of Severe Illness), which investigated the safety, tolerability, and immunogenicity of ABRYSVO in adults 18 through 59 years of age at risk of RSV-associated LRTD due to certain chronic medical conditions. It was also supported by the thousands of persons vaccinated in clinical trials involving ABRYSVO in this age group. 1,2,3,4 The results of MONeT and other studies have been published in peer-reviewed journals.

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 U.S in October 2024, the FDA approved ABRYSVO for the prevention of lower respiratory tract disease caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. Prior, in May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age and older. 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.

In addition to the most recent EU approval, ABRYSVO has received approvals for both indications in multiple countries worldwide.

U.S. INDICATIONS FOR ABRYSVO

ABRYSVO ® is a vaccine indicated in the U.S. 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 U.S. 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
  • 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 versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% 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 U.S. Securities and Exchange Commission and available at www.sec.gov and www.Pfizer.com   .

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 .

Media Contact:
PfizerMediaRelations@Pfizer.com
+1 (212) 733-1226

Investor Contact:
IR@Pfizer.com
+1 (212) 733-4848

News Provided by Business Wire via QuoteMedia

PFE
The Conversation (0)
Arvinas and Pfizer Announce Upcoming Vepdegestrant  Poster Presentations at the 2023 European Society for Medical Oncology  Breast Cancer Annual Congress

Arvinas and Pfizer Announce Upcoming Vepdegestrant Poster Presentations at the 2023 European Society for Medical Oncology Breast Cancer Annual Congress

Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced they will present updated data related to vepdegestrant (ARV-471) at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. Vepdegestrant is a novel investigational PROTAC ® estrogen receptor (ER) protein degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic ER positivehuman epidermal growth factor receptor 2 (HER2) negative (ER+HER2-) breast cancer. Four posters will be presented during the poster session at the annual congress, which will be held from May 11-13, 2023, in Berlin, Germany.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Pfizer Reports First-Quarter 2023 Results

Pfizer Reports First-Quarter 2023 Results

  • First-Quarter 2023 Revenues of $18.3 Billion
    • Expected Decline in Comirnaty (1) Revenue Drove 26% Operational Decrease in First-Quarter 2023 Revenues
    • First-Quarter 2023 Revenues from Comirnaty (1) and Paxlovid of $7.1 Billion
    • Excluding Contributions from Comirnaty (1) and Paxlovid, Revenues Grew 5% Operationally
  • First-Quarter 2023 Reported Diluted EPS (2) of $0.97, a Year-Over-Year Decline of 29%, and Adjusted Diluted EPS (3) of $1.23, a Year-Over-Year Decline of 24%
  • Pfizer Reaffirms Full-Year 2023 Financial Guidance (4)
  • Pfizer Continued to Make Significant Progress Toward an Unprecedented Number of Anticipated New Product and Indication Launches; Milestones Include FDA Approvals for Zavzpret, Cibinqo for Adolescents and Prevnar 20 in Pediatric Patients

Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2023 and reaffirmed full-year 2023 financial guidance.

The first-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
XTANDI®  plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

XTANDI® plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

Data from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting

Results show the potential for XTANDI to add to the standard of care in prostate cancer, if approved

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

  • PREVNAR 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect against all 20 serotypes contained in the vaccine
  • PREVNAR 20 builds on PREVNAR 13 ® and includes seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases. 1
  • The vaccine further advances Pfizer's pediatric pneumococcal vaccine portfolio and builds on more than 20 years of Pfizer leadership, legacy and innovation in developing pneumococcal conjugate vaccines

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR ® .

"Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children," 1,2 said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "This important PREVNAR 20 approval builds on more than 20 years of real-world impact with PREVNAR and PREVNAR 13, safety data, and effectiveness; highlighting Pfizer's leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life threatening infections. We are grateful to the families and clinical investigators who participated in this research and our colleagues who have worked tirelessly to develop this breakthrough vaccine."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Pfizer Declares Second-Quarter 2023 Dividend

Pfizer Declares Second-Quarter 2023 Dividend

Board of Directors approves quarterly cash dividend of $0.41 per share

Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 second-quarter 2023 dividend on the company's common stock, payable June 9, 2023, to holders of the Common Stock of record at the close of business on May 12, 2023. The second-quarter 2023 cash dividend will be the 338th consecutive quarterly dividend paid by Pfizer.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Pfizer Declares Second-Quarter 2025 Dividend

Board of Directors approves quarterly cash dividend of $0.43 per share

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

ACIP Votes to Expand Recommendation for Pfizer's RSV Vaccine ABRYSVO® to Include Adults Aged 50 to 59 at Increased Risk of Disease

  • Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD). This includes ABRYSVO ® (Respiratory Syncytial Virus Vaccine), which in October 2024, the U.S. Food and Drug Administration approved for the prevention of RSV-associated LRTD in adults aged 18 to 59 at increased risk of severe disease.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Pfizer Provides Update on Oral GLP-1 Receptor Agonist Danuglipron

Pfizer Inc. (NYSE: PFE) today announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for chronic weight management.

Pfizer's dose-optimization studies of once-daily formulations of danuglipron ( NCT06567327 and NCT06568731 ) met key pharmacokinetic objectives and confirmed a formulation and dose with the potential to deliver a competitive efficacy and tolerability profile in Phase 3 testing, based on earlier studies of twice-daily danuglipron. While the overall frequency of liver enzyme elevations across the over 1,400 participant safety database of danuglipron is in-line with approved agents in the class, a single asymptomatic participant in one of the dose-optimization studies experienced potential drug-induced liver injury which resolved after discontinuation of danuglipron. After a review of the totality of information, including all clinical data generated to date for danuglipron and recent input from regulators, Pfizer has decided to discontinue development of the molecule.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Invion Limited (ASX:IVX)

Invion Limited

Keep reading...Show less

Pfizer Invites Shareholders to Attend Virtual 2025 Annual Meeting of Shareholders on April 24

Pfizer Inc. (NYSE: PFE) announced today that its shareholders and the general public are invited to access its virtual 2025 Annual Meeting of Shareholders at 9:00 a.m. EDT on Thursday, April 24, 2025. Pfizer has designed the virtual Annual Meeting to ensure that its shareholders who participate will be afforded comparable rights and opportunities to participate as they would at an in-person meeting.

Beginning today, shareholders can find additional information on accessing and registering for the virtual meeting at https://meetnow.global/PFE2025 . On the day of the Annual Meeting, shareholders may begin logging into the virtual meeting platform at 8:45 a.m. EDT using either the control number found on their proxy card, voting instruction form or the notice that was previously received. Only shareholders who log into the meeting using a control number will have the ability to ask questions or vote during the live meeting.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×