Newly Approved Drug to Protect Infants from Life-Threatening Respiratory Virus

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Infants to Receive New Drug to Protect Against Respiratory Virus, Say U.S. Health Officials

Infants across the United States will soon have access to a newly approved drug that protects against a respiratory virus, according to U.S. health officials. The drug, developed by AstraZeneca and Sanofi, is a lab-made antibody that helps the immune system fight off the virus known as respiratory syncytial virus (RSV). RSV typically sends tens of thousands of American children to the hospital each year, and the new drug is expected to fill a critical need as there are currently no vaccines for babies.

While RSV is generally a mild illness for most healthy individuals, it can be life-threatening for young infants and the elderly. The RSV season in the U.S. usually lasts from November through March, and it is estimated that around 58,000 children under the age of 5 are hospitalized for RSV annually, with several hundred deaths reported.

An advisory panel to the Centers for Disease Control and Prevention (CDC) recommended a one-time shot of the new drug for infants born just before or during the RSV season, as well as for those under 8 months old before the season starts. The panel also suggested a dose for certain high-risk children aged 8 to 19 months. The recommendations were later approved by the CDC director.

Dr. Mandy Cohen expressed her excitement about the new tool to protect infants, particularly after a severe RSV season last year. The drug, to be sold under the brand name Beyfortus, is expected to be available in the fall. The cost per dose is set at $495, and it will be covered by insurance, although there may be initial challenges with providing the shot and obtaining reimbursement from insurers.

Earlier this year, the Food and Drug Administration (FDA) approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer. In addition, Pfizer’s vaccine for pregnant women is expected to receive FDA approval in August, with the aim of protecting newborns from RSV.

While the new drug is not classified as a vaccine, the expert panel also recommended including it in Vaccines for Children, a government program that provides free immunizations. The American Academy of Pediatrics is urging hospitals to stock Beyfortus so that newborns can receive it before going home during the RSV season.

Overall, the introduction of this new drug offers hope in the fight against RSV and the protection of vulnerable infants. The Associated Press Health and Science Department shares that the AP is solely responsible for all content in this article.

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