Pfizer obtains FDA OK for first vaccine for pregnant women to prevent RSV in infants

The Food and Drug Administration has given Pfizer permission for Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant women to prevent lower respiratory tract disease and severe LRTD caused by respiratory syncytial virus in infants from birth through 6 months of age.

Abrysvo is approved for use at 32 through 36 weeks gestational age of pregnancy. Abrysvo is administered as a single dose injection into the muscle. The FDA approved Abrysvo in May for the prevention of LRTD caused by RSV in individuals 60 years of age 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, director of the FDA's Center for Biologics Evaluation and Research. "This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease."

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RSV is a highly contagious virus that causes respiratory infections in individuals of all age groups. It is the most frequent cause of lower respiratory tract illness in infants worldwide. In most parts of the United States, RSV circulation is seasonal, typically starting during the fall and peaking in the winter. The virus is especially common in children, and most individuals can be expected to be infected with RSV by the time they reach two years of age.

While RSV most often causes cold-like symptoms in infants and young children, it also can lead to serious LRTD, such as pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). In infants and children, the risk of RSV-associated LRTD is highest during the first year of life. According to the Centers for Disease Control and Prevention, RSV is the leading cause of infant hospitalization in the United States.

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