Infants should be given a recently-approved drug to protect them from a respiratory virus that hospitalizes tens of thousands of American children each year, U.S. health officials said Thursday.
RSV infection is a common cold-like nuisance for most healthy people, but it can be life-threatening for the young and old. There are no vaccinations for babies yet new druga lab-made antibody that helps the immune system fight off the virus may fill an urgent need.
Developed by AstraZeneca and Sanofi, the drug is expected to be ready in the fall before the RSV season, typically November through March. In the United States, approximately 58,000 children under the age of 5 are hospitalized with RSV each year, and several hundred die.
A panel of outside consultants from the Centers for Disease Control and Prevention recommended the one-off vaccination for infants born just before or during RSV season and for infants less than 8 months old before the season began. They also recommended a dose for some 8- to 19-month-old children who are at higher risk of developing severe RSV disease.
The CDC director endorsed the panel’s recommendations later Thursday.
“We had a terribly poor RSV season last year and I’m thrilled that we have a new tool to protect our young children,” said Dr. Mandy Cohen told The Associated Press earlier this week.
The drug, to be sold under the brand name Beyfortus, is said to cost $495 per dose and will be covered by insurance. Panellists acknowledged that giving the chance and getting providers reimbursed by insurers will initially be a challenge.
In May, the Food and Drug Administration approved two RSV vaccines older adults from GlaxoSmithKline and Pfizer. The FDA is expected to make a decision on approval in August Pfizer vaccine for pregnant womenwith the goal of passing the protection on to their newborns.
Although the new drug is not a vaccine, the expert panel also endorsed inclusion in Vaccines for Children, a government program that provides free vaccinations. The American Academy of Pediatrics is urging hospitals to stock Beyfortus so newborns can receive it before they go home during RSV season.
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