FDA Okays Pfizer's RSV Vaccine ABRYSVO For Adults Aged 18 To 59 At Increased Risk For Disease

(RTTNews) - Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration approved ABRYSVO (Respiratory Syncytial Virus Vaccine), the company's bivalent RSV prefusion F or RSVpreF vaccine, for the prevention of lower respiratory tract disease or 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.

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.

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.

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