New RSV shot for babies given green light by CDC. Here's what parents need to know

The drug, developed by AstraZeneca and Sanofi, is expected to be rolled out in the fall, before RSV season

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Babies under 8 months old should be given a recently approved shot to protect them against respiratory syncytial virus, an infection that sickens tens of thousands of U.S. children each year, according to health officials.

A panel of outside advisers to the Centers for Disease Control and Prevention on Thursday recommended the one-time shot for infants born just before or during the RSV season and for those less than 8 months old before the season starts  There are no vaccines for babies yet so the new drug, a lab-made antibody that helps the immune system fight off the virus, is expected to fill a critical need.

While almost every child contracts RSV, most only have mild cold symptoms. But a large number of kids do get very sick from the virus, according to Dr. Julie Holland, a pediatrician Chicagoland Children's Health Alliance. On an annual basis, somewhere between 60,000 to 80,000 children under 5 years old are hospitalized with the virus in the U.S., and between 100 to 300 deaths in that age group are attributed to the virus.

The drug, developed by AstraZeneca and Sanofi, is expected to be rolled out in the fall, before RSV season, which typically starts in November. In clinical trials, the shot has reduced hospitalizations for RSV by 60% and decreased the need to seek out medical care for any type of visit by about 75%, Holland said.

"So really, a remarkable decrease in severity of illness and number of hospitalizations in kids," the doctor stated. "So we're very excited about this."

The CDC director signed off on the panel’s recommendations later Thursday.

The drug, to be sold under the brand name Beyfortus, is expected to cost $495 per dose, and to be covered by insurance. Panelists acknowledged that it will be a challenge at first to give the shot and for providers to be reimbursed by insurers.

"I think the big question is insurance companies are going to cover this, and they should," Holland stated, in part. "...We are very hopeful that this will be a completely covered treatment for all kids, much like vaccines are covered at 100% right now."

Although the new drug is not a vaccine, the expert panel also supported including it in Vaccines for Children, a government program providing free immunizations. The American Academy of Pediatrics is urging hospitals to stock Beyfortus so that newborns can get it during RSV season before they go home.

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