Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO ® (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.
"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 U.S. Commercial Officer and Executive Vice President, Pfizer. "With this approval, we are proud that ABRYSVO is now the only RSV vaccine indicated for adults aged 18 to 49 at increased risk for the disease, expanding on its existing indications for older adults and pregnant women."
The FDA's decision is based on inferred efficacy 1 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 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 U.S. adults 18 to 49 years of age, 9.5% have an underlying chronic condition, such as obesity, diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease, and asthma 2 that puts them at increased risk of developing, and being hospitalized for, RSV-associated LRTD, and this rises to 24.3% among those 50 to 64 years of age. 3,4
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 United States.
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 versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo)
View the full ABRYSVO Prescribing Information.
