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FDA Approves Pfizer's Abrysvo RSV Vaccine for Adults 18-59 at Increased Risk

• The FDA has approved Pfizer's Abrysvo vaccine for adults aged 18-59 at increased risk of RSV-related lower respiratory tract disease (LRTD). • This approval expands Abrysvo's indication, making it the only RSV vaccine available for this younger adult population with specific chronic conditions. • The decision was based on inferred efficacy from a Phase 3 clinical trial, MONeT, assessing safety, tolerability, and immunogenicity in at-risk adults. • Abrysvo remains approved for adults 60 and older and for maternal immunization to protect infants up to 6 months.

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Abrysvo (Respiratory Syncytial Virus 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, a bivalent RSV prefusion F (RSVpreF) vaccine, now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. It also remains the only RSV immunization approved for pregnant individuals (32-36 weeks of gestation) to protect infants from birth up to 6 months of age.

Clinical Basis for Approval

The FDA's decision is based on inferred efficacy 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). This trial investigated the safety, tolerability, and immunogenicity of Abrysvo in adults at risk of RSV-associated disease due to certain chronic medical conditions. Pfizer intends to submit results from MONeT for publication in a peer-reviewed scientific journal and for presentation at an upcoming scientific conference.

Impact on At-Risk Adults

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 that puts them at increased risk of developing, and being hospitalized for, RSV-associated LRTD. This rises to 24.3% among those 50 to 64 years of age.

About RSV and Abrysvo

Respiratory syncytial virus (RSV) is a contagious virus and a common cause of respiratory illness. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. 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. 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.
Abrysvo is an unadjuvanted, bivalent vaccine 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.

Current Indications

Abrysvo is 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
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Reference News

[1]
U.S. FDA Approves Pfizer’s RSV Vaccine Abrysvo for Adults Aged 18 to 59 at Increased Risk for Disease
drugs.com · Apr 10, 2025

The FDA approves Pfizer's RSV vaccine Abrysvo for adults aged 18 to 59 at increased risk of lower respiratory tract dise...

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