The FDA has approved RSV shots for babies : NPR

Starting this fall, babies in the U.S. will be able to get a shot that protects them from a severe respiratory illness caused by RSV. The FDA gave its approval on Monday.

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This fall, many parents in the United States will be able to get a shot for their babies that protects them from a severe respiratory illness caused by RSV. The Food and Drug Administration approved the shot, and NPR’s Pien Huang has more.

PIEN HUANG, BYLINE: The shot is called Beyfortus, a name meant to evoke baby strength. That’s because it strengthens the baby’s immune system against one of its most common threats – respiratory syncytial virus, or RSV. It’s the leading cause of hospitalizations in U.S. babies, landing between 60 to 80,000 in the hospital each year. The drugmakers AstraZeneca and Sanofi hope their product can prevent many of those. In their clinical trials involving almost 3,000 babies, one shot of the antibody drug lowered the risks of hospitalization by 60 to 80%. Their data, shared last month with a panel of FDA advisers, looked convincing to Dr. Mary Anne Jackson, a pediatrician in Kansas City, Mo.

MARY ANNE JACKSON: There’s good safety data and there’s good efficacy data that shows that the product will prevent a significant number of cases of RSV lower respiratory tract disease.

HUANG: The shot is designed to prevent serious RSV infections. Its antibodies float in the bloodstream looking for the virus. When they find it, they stick to it in places that stop the virus from entering cells. Jon Heinrichs is head of innovation at Sanofi.

JON HEINRICHS: Well, it works very rapidly. We know that within a matter of days you achieve very high levels of antibodies that are likely to be protective.

HUANG: That protection lasts for at least five months. The drug is approved for newborns and infants in their first RSV season and for children up to 2 years old with additional medical risks for their second RSV season. Dr. Marcus Plescia with the Association of State and Territorial Health Officials says it may take a while for parents to warm up to the new product.

MARCUS PLESCIA: During the RSV season, it’s recommended very soon after birth. And, you know, a lot of parents are a little bit cautious about wanting to give really young children things. And so it may take a little bit of time to really build confidence.

HUANG: Sanofi hasn’t yet announced how much the drug will cost.

Pien Huang, NPR News.

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