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Nirsevimab doses for 2024-2025 RSV season can be reserved with new program

News
Article

Nirsevimab was approved by the FDA on July 17, 2023, ahead of the traditional RSV season, though in October, the Centers for Disease Control and Prevention (CDC) recommended it be prioritized for the highest-risk infants amid limited availability.

Nirsevimab doses for 2024-2025 RSV season can be reserved with new program | Image Credit: © Julia - © Julia - stock.adobe.com.

Nirsevimab doses for 2024-2025 RSV season can be reserved with new program | Image Credit: © Julia - © Julia - stock.adobe.com.

Sanofi and its manufacturing partner AstraZeneca are exploring ways to make nirsevimab (Beyfortus) 50 mg and 100 mg doses for the prevention of respiratory syncytial virus (RSV) readily available for the 2024 to 2025 RSV season.

In these efforts, the companies have created the Beyfortus Reservation Program, which, according to the manufacturers, "provides critical insight on customer demand and allows for prioritized fulfillment of requests placed through this program. It offers providers flexibility in scheduling shipments and the ability to cancel orders within terms."

According to a press release, Sanofi stated, "Currently, insurance coverage is in place for nearly 100% of infant lives in the US. To help facilitate ongoing access to available doses for eligible babies, Sanofi continues to work closely with providers in the private market and the Vaccines for Children (VFC) program to best support the communities they serve. Nearly 40% of eligible babies could have the ability to be immunized against RSV with [nirsevimab] this RSV season."

Nirsevimab was approved by the FDA on July 17, 2023, ahead of the traditional RSV season, though in October, the Centers for Disease Control and Prevention (CDC) recommended it be prioritized for the highest-risk infants amid limited availability.

In addition to the new program, Sanofi stated it is taking action to reach a greater preparedness level for the 2024 to 2025 RSV season. Sanofi said it will "continue to work with AstraZeneca to expand the Beyfortus manufacturing network to allow for a significant increase in supply for the 2024-2025 season and cover the entire [United States] demand."

The majority of doses are expected to be available before October, ahead of the traditional RSV season.

Aside from the new program, normal order widows will be available from September 2024 to February 2025. The Reservation Program does not apply to the VFC program, though Sanofi will continue to work with the CDC to ensure supply for the VFC program, noting providers should "consult their state or local VFC program" when ordering nirsevimab for their respective VFC patients for the 2024 2025 season.

Nirsevimab is indicated to help prevent RSV in newborns and babies under 1 year of age born during or entering their first RSV season and for children up to 24 months of age who are at increased risk of severe RSV disease through their second RSV season.

Reference:

Sanofi launches Beyfortus (nirsevimab-alip) Reservation Program for 2024-2025 RSV season in US. Sanofi. Press release. February 1, 2024. Accessed February 2, 2024. https://www.news.sanofi.us/2023-02-01-Sanofi-launches-Beyfortus-R-nirsevimab-alip-Reservation-Program-for-2024-2025-RSV-season-in-U-S

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