An independent advisory committee to the FDA will decide on Thursday whether to recommend an RSV vaccine for infants. If approved, the shot, which is administered to pregnant mothers, would be the first of its kind.
FDA panel to vote on the first RSV vaccine for infants, administered to pregnant mothers
“Before the pandemic, RSV was the No. 1 cause of infant hospitalization in the United States, so this is a big deal,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital. Levy is a temporary voting member of the FDA panel but isn’t involved in Thursday’s vote.
In a clinical trial with nearly 7,400 participants, the vaccine lowered the risk of severe disease from RSV among infants by 82% within roughly three months after birth. By around six months, that efficacy was around 69%. InfantsThe shot also lowered the risk of developing respiratory disease from RSV that required a doctor's visit by 51% within about six months. After that, however, the vaccine did not appear to make a big difference.
However, the agency noted that there was a slightly higher rate of preterm births — defined as before 37 weeks' gestation — among people who received the vaccine versus those who got a placebo . That difference wasn’t statistically significant, though, so it’s unclear whether it was vaccine-related.in the general population: around 10%, according to the Centers for Disease Control and Prevention.
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