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# FDA Approves Expanded Abrysvo Indication
- URL: https://www.fdaweb.com/fda-approves-expanded-abrysvo-indication/
- Published: 2024-10-23T12:00:00.000Z
- Updated: 2026-09-14T14:44:48.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158043

FDA has approved expanding the indication for Pfizer’s respiratory syncytial virus (RSV) Abrysvo vaccine to cover the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age. Abrysvo had been approved for those aged 60 and older.

A company [statement](https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-rsv-vaccine-abrysvor-adults-aged-18?ref=fdaweb.com) says the vaccine offers the broadest RSV indication for adults and is the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth to six months of age.

Approval of the expanded indication was based on inferred efficacy 1 from the pivotal Phase MONeT trial, the statement says.

Abrysvo is defined as an unadjuvanted, bivalent vaccine that was designed to provide broad protection against RSV-LRTD, regardless of the virus subgroup.