Nirsevimab reservation program enrollment deadline extended

In a recent publication in The Lancet, data revealed nirsevimab (Beyfortus; Sanofi and AstraZeneca) reduced respiratory syncytial virus (RSV) hospitalizations in infants by 82%. Now, Sanofi has announced a deadline extension for providers to enroll in its Beyfortus Reservation Program, with a new deadline of May 17, according to an article from The American Academy of Pediatrics (AAP).^1-3

Providers will have until the May 17 date to submit requests for their anticipated supply of the monoclonal antibody for the 2024-2025 RSV season. Sanofi announced its ordering system for all vaccines will be updated and unavailable from May 24 to June 3. After this period, ordering will be limited through June 17, according to the AAP.¹

In February 2024, Sanofi and AstraZeneca created the program to provide insight on customer demand and allow for prioritized fulfillment of nirsevimab requests. At the time of the program announcement, Sanofi stated greater action was being taken to be prepared for the 2024-2025 RSV season, in efforts "to allow for a significant increase in supply for the 2024-2025 season and cover the entire [United States] demand."²

Last month, according to the AAP, nirsevimab's price was raised by 5%, with a new list price of $519.75 for 50 mg and 100 mg doses of the long-acting monoclonal antibody to prevent RSV in infants. At the time, a Sanofi spokesperson cited that "evolving market dynamics" contributed to the price increase. Providers participating in the companies' Reservation Program can receive a 2% discount on orders placed through VaccineShop.com between July 1 and August 31.^1,4

Program participants will be able to reserve nirsevimab doses during July and August, and will be eligible for priority shipping, preferred monthly shipping schedules, 90-day payment terms, and cancellation, according to the AAP. Customers would receive shipments in late August or early September and throughout the RSV season.¹

Nirsevimab was approved by the FDA on July 17, 2023, ahead of the traditional RSV season, though in October 2023, the Centers for Disease Control and Prevention (CDC) recommended it be prioritized for the highest-risk infants amid limited availability.²

"[The FDA approval of nirsevimab] really put other tools in our toolbox that we could use to prevent the severe complications that were being seen with RSV, especially in the younger infants under 6 months of age," said Tina Tan, MD, FAAP, FIDSA, FPIDS, editor in chief, Contemporary Pediatrics, professor of pediatrics, Feinberg School of Medicine, Northwestern University, pediatric infectious diseases attending, Ann & Robert H. Lurie Children's Hospital of Chicago, in a previous interview with Contemporary Pediatrics.³

"When nirsevimab was first approved, there were parents that were literally calling and clamoring to try and get the vaccines for their babies or the monoclonal antibody for their babies." said Tan.³

Nirsevimab is administered as a single intramuscular injection prior to or during the RSV season, and is indicated to help prevent RSV in newborns and babies under 1 year of age born during or entering their first RSV season. The monoclonal antibody is also indicated for children up to 24 months of age who are at an increased risk of severe RSV through their second RSV season.²

In recent findings published in The Lancet, nirsevimab reduced hospitalizations by 82% in infants under 6 months of age compared to those that received no RSV intervention.³ In March 2024, the CDC estimated that nirsevimab is 90% effective against RSV-associated hospitalizations in infants during their first RSV season.⁵

A month after nirsevimab's FDA approval, it was unanimously recommended by the CDC's Advisory Committee on Immunization Practices (ACIP) for infants younger than 8 months of age. In the same month, the AAP also voted in unanimous fashion to recommend the routine use of nirsevimab in newborns and infants.⁵

References:

1. Jenco M. Sanofi extends deadline to enroll in nirsevimab reservation program. The American Academy of Pediatrics. May 8, 2024. Accessed May 9, 2024. https://publications.aap.org/aapnews/news/28803/Sanofi-extends-deadline-to-enroll-in-nirsevimab?searchresult=1?autologincheck=redirected

2. Fitch, J. Nirsevimab doses for 2024-2025 RSV season can be reserved with new program. Contemporary Pediatrics. February 2, 2024. Accessed May 9, 2024. https://www.contemporarypediatrics.com/view/nirsevimab-doses-for-2024-2025-rsv-season-can-be-reserved-with-new-program

3. Fitch, J. Nirsevimab reduced RSV hospitalizations in infants by 82%, new data show. Contemporary Pediatrics. May 2, 2024. Accessed May 9, 2024. https://www.contemporarypediatrics.com/view/nirsevimab-reduced-rsv-hospitalizations-in-infants-by-82-new-data-shows

4. Fitch, J. RSV monoclonal antibody nirsevimab to be 5% more expensive. Contemporary Pediatrics. April 15, 2024. Accessed May 9, 2024. https://www.contemporarypediatrics.com/view/rsv-monoclonal-antibody-nirsevimab-to-be-5-more-expensive

5. Fitch, J. CDC estimates nirsevimab is 90% effective against RSV-associated hospitalizations. Contemporary Pediatrics. March 7, 2024. Accessed May 9, 2024. https://www.contemporarypediatrics.com/view/cdc-estimates-nirsevimab-90-effective-against-rsv-associated-hospitalizations