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.
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.