In the face of Scarcity, the CDC has Ordered Additional Doses of Newborn RSV Medication from Sanofi and AstraZeneca


The Centers for Disease Control and Prevention (CDC) has taken steps to address the new drug shortage for protecting infants from respiratory syncytial virus (RSV). The CDC expedited the release of more than 77,000 additional doses of Beyfortus, a monoclonal antibody developed by Sanofi and AstraZeneca, as cases of RSV rise in some parts of the U.S. Hospitals and pediatricians have faced challenges in stocking the drug due to a “supreme demand.”

Beyfortus is one of two available treatments in the U.S. designed to protect infants from RSV, the leading cause of hospitalization among babies. The shortage and insurance coverage issues have raised concerns about infants not receiving critical protection against RSV. The CDC’s move aims to increase the availability of the drug, especially ahead of the holiday season.

RSV is a common respiratory infection causing mild, cold-like symptoms but can lead to severe cases in children and older adults. Each year, the virus causes a few hundred deaths in children younger than 5 and 6,000 to 10,000 deaths in seniors. RSV also results in 58,000 to 80,000 hospitalizations among children under 5 annually, according to the CDC. The new drug, Beyfortus, received approval in August as a monoclonal antibody to protect infants from RSV.

The additional doses of Beyfortus will be distributed immediately to physicians and hospitals through commercial channels and the Vaccines for Children Program. The Vaccines for Children Program covers the cost of shots for uninsured and underinsured kids. The CDC, along with the Food and Drug Administration, will maintain close contact with the drug manufacturers to ensure the availability of additional doses through the end of 2023 and early 2024 to meet demand. The goal is to expand access to this critical immunization to provide parents with peace of mind during the winter virus season.

The U.S. has seen a sharp uptick in RSV cases since mid-October, with nearly 5,000 cases detected through testing in the week ending Nov. 4. This is the highest level since last winter, and the U.S. experienced an unusually severe RSV season last year, overwhelming hospitals across the country. The public’s discontinuation of COVID-19 pandemic health measures contributed to increased RSV cases in children and older adults.

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