FDA Approves Groundbreaking RSV Vaccine for Infants and Pregnancy

The FDA has approved the first vaccine, called Abrysvo, designed to prevent respiratory syncytial virus (RSV) infections in infants. The single-dose injections, made by Pfizer, are administered to pregnant mothers in their third trimester to provide protection to newborns from the moment they are born. Abrysvo has already been approved for use in preventing RSV in older adults. Clinical studies have shown that the vaccine reduces the risk of lower respiratory tract disease in infants by about 82% in the first 90 days after birth. However, the vaccine has been associated with a slightly higher rate of preterm births and other conditions, so postmarketing studies will be conducted to evaluate these risks.