FDA panel recommends drug to prevent RSV in infants

Nabil Anas

Global Courant

An independent Food and Drug Administration advisory committee voted Thursday to recommend an injectable drug that could protect babies up to 2 years old from RSV.

The 21-member panel voted unanimously to recommend the injection for newborns and infants during their first months of exposure to RSV. The group also voted 19 to 2 to give a second dose to children up to age 2 who are vulnerable to severe infections — such as children with chronic heart or lung disease — during their second season of RSV.

The FDA must now decide whether to approve the injection, but will likely follow the committee’s recommendation.

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In a study of nearly 1,500 infants, the injection reduced the risk of developing respiratory disease from RSV that required a doctor’s visit by nearly 75% for at least five months.

In a study of more than 1,400 premature babies – a group at particular risk – the injection was found to reduce the risk of developing a respiratory disease from RSV, which required doctor visits, by about 70% for at least five months. It lowered the risk of hospitalization from RSV by about 78% over that time.

“The studies presented showed clear evidence of efficacy and reassuring evidence of safety in all subgroups presented, and I think this could be a real game changer,” said Dr. George Siberry, a member of the FDA panel and a medical officer with the US Agency for International Development.

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