According to U.S. health officials, infants should receive a newly approved drug to protect them from a respiratory virus that annually hospitalizes tens of thousands of American children.
While an infection with RSV may be a mild cold for most healthy individuals, it can be life-threatening for infants and the elderly. Currently, there are no vaccines available for babies, making the emergence of a new drug a critical necessity. This lab-made antibody, developed by AstraZeneca and Sanofi, aids the immune system in combating the virus.
The drug, expected to be named Beyfortus, will be ready in the fall before the RSV season, which typically occurs from November through March. Each year, around 58,000 children under the age of 5 are hospitalized for RSV in the U.S., with several hundred deaths reported.
A panel of outside advisers to the Centers for Disease Control and Prevention (CDC) has recommended a one-time shot of the drug for newborns born just before or during the RSV season, as well as for infants under 8 months old before the season begins. They also suggested a dose for high-risk 8- to 19-month-olds who are more susceptible to serious illnesses caused by RSV.
The CDC director approved the recommendations made by the panel later on Thursday.
Dr. Mandy Cohen expressed her excitement about the new tool for infant protection in light of the severe RSV season experienced last year.
Regarding the cost of the drug, it is expected to be priced at $495 per dose and covered by insurance. However, panelists acknowledged that providing the shot and securing reimbursement from insurers may pose initial challenges.
In May, the Food and Drug Administration (FDA) approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer. Furthermore, Pfizer’s vaccine for pregnant women is awaiting FDA approval in August, with the goal of transferring protection to newborns.
Although the new drug is not classified as a vaccine, the expert panel supports its inclusion in Vaccines for Children, a government program that offers free immunizations. The American Academy of Pediatrics is urging hospitals to stock up on Beyfortus to administer it to newborns during the RSV season before they are discharged.
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