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Yale Pediatric Vaccine Trials Program's Vital Role in Approval of New Bivalent RSV Vaccine

August 25, 2023

The Yale Pediatric Vaccine Trials Program played a significant role in another vaccine licensure. On August 21, 2023, the United States Food and Drug Administration (FDA) approved a new bivalent RSV preF vaccine for the prevention of Lower Respiratory Tract Disease (LRTD) and severe LRTD caused by RSV (Respiratory syncytial virus) in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.

Dr. Inci Yildirim, director of Yale Pediatric Vaccine Trials Program, noted that this is the first vaccine that has been approved for pregnant individuals that can protect infants against very common and potentially life-threatening RSV infections especially during the first year of life.