Pregnant Women Can Get RSV Vaccine

The U.S. Food and Drug Administration (FDA) today approved ABRYSVO™, the first vaccine approved for use in pregnant women to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through six months of age.

Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy, says the FDA.

Previously, the FDA approved Pfizer Inc.'s Abrysvo in May 2023 to prevent LRTD caused by RSV in individuals 60 and older.

"RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, in a press release on August 21, 2023.

"This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease." 

Recently, the FDA approved Beyfortus™ for infants born during or entering their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

On July 17, 2023, Beyfortus became the first extended half-life monoclonal antibody offering passive immunization to prevent LRTI caused by RSV. 

RSV is a highly contagious virus that causes respiratory infections in individuals of all age groups, causing frequent outbreaks. Most individuals can be expected to be infected with RSV by the time they reach two years of age, says the FDA.

In most parts of the U.S., RSV circulation is seasonal, typically starting in Florida and peaking in the winter.

A study published by PLOS Medicine in July 2023 concluded RSV disease burden is high in the nearly 600 million children under five living in 121 low-income and middle-income countries. The peak age of community-based RSV incidence is 4.8 months.