money FDA panel recommends RSV shot for infants. Will FDA approve it?
A U.S. Food and Drug Administration advisory panel recommended that Beyfortus, developed by Sanofi and AstraZeneca, be approved as an RSV vaccine for infants.
RSV, or respiratory syncytial virus, is a common virus that causes mild, cold-like symptoms and is usually cured in about two weeks — but it can be deadly for infants or vulnerable adults, the U.S. Centers for Disease Control and Prevention said.
Each year, 100 to 300 RSV deaths occur for children under age 5 and between 6,000 to 10,000 deaths for adults older than 65, per the CDC.
The New York Times said all 21 members of the panel voted in favor of allowing infants born during or entering their first RSV season to get the shot, while 19-2 voted in favor of giving the shot to children up to 2 years old who are vulnerable due to severe diseases.
One of the committee members who voted against the recommendation was Sally Hunsberger, a biostatistician at the National Institutes of Health, according to NBC News.
Hunsberger told NBC News, “It’s a bit of a weak ‘no,’ but hopefully that will just emphasize that I feel like we do need more data.”
Beyfortus “would be more affordable and more widely available than the single existing preventive drug — a monoclonal antibody shot called palivizumab — which requires monthly administration and is reserved for babies at high medical risk,” according to NPR.
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U.S. News & World Report said, “Sanofi and AstraZeneca gave more than 3,200 infants the antibody shot during studies of the vaccine. One of those studies found that the vaccine’s effectiveness against very severe RSV was 79% after six months.”
“In a study of more than 1,400 infants born prematurely — a group at particular risk — the injection was found to lower the risk of developing respiratory disease from RSV that required doctors’ visits by around 70% for at least five months,” NBC News added.
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Beyfortus
NBC News said the antibody drug is already approved in Europe, Canada and the United Kingdom.
The Times predicted that Beyfortus will most likely be available this coming fall if the FDA approves it.
Dr. Lindsey Baden, an infectious diseases physician at Brigham and Women’s Hospital in Boston and chair of the FDA’s Antimicrobial Drugs Advisory Committee, told NPR, “Overall, all committee members were impressed with the conduct of the study and the clean results that were presented.”
A previous RSV shot for vulnerable adults was approved by the FDA in May, making history as the first vaccine made against the virus for adults older than 60, according to the Deseret News.
