FDA panel recommends injectable drug to prevent RSV in infants

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FDA panel considers an injectable drug that prevents RSV in infants

up to 80,000 hospitalizations and up to 300 deaths per year in the U.S. Most people are infected by age 2.

Active immunization refers to the protection from vaccines, but no RSV vaccine for infants has been approved. In a study of nearly 1,500 infants, the shot lowered the risk of developing respiratory disease from RSV that required a doctor's visit by nearly 75% for at least five months. “The studies as presented showed clear evidence of efficacy and reassuring evidence of safety across all the subgroups presented, and I think that this could be a real game changer,” said Dr. George Siberry, a member of the FDA panel and a medical officer at the U.S. Agency for International Development.

 

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