Sanofi Gears Up for RSV Season, Begins Shipping Beyfortus
The manufacturing line producing the company’s branded form of nirsevimab-alip has been approved by the FDA.
In a climate where an estimated two out of three babies get respiratory syncytial virus (RSV) disease,1 Sanofi has started shipping Beyfortus (nirsevimab-alip) 50 mg and 100 mg injection doses in the United States to private healthcare providers and to the Centers for Disease Control and Prevention for its Vaccines for Children program to make sure that the most batches are available before the start of RSV season.2 The upcoming RSV season for the Northern Hemisphere—which runs November-March—is fast approaching.
Specifically, the objective for the US market is to have enough doses for not only every eligible baby born outside of the RSV season to have access to the show at his or her regular checkup, but even for those who are born during the season. According to Sanofi, the company’s vaccine is considered “the first and only long-acting monoclonal antibody approved for the prevention of RSV lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.” The FDA had approved the drug in July 2023 given those age parameters.
"We're proud to offer Beyfortus doses to help protect every eligible baby in the US this RSV season,” said Thomas Grenier, head of vaccines, North America, Sanofi. This accomplishment aimed at equitable access was made possible through close partnership with the White House, Centers for Disease Control and Prevention, the US Food and Drug Administration, and healthcare providers to make Beyfortus widely available. This upcoming season, we look forward to Beyfortus offering its demonstrated real-world protection to as many infants as possible."
AstraZeneca has been assisting Sanofi with the development and manufacturing process. In fact, following FDA’s approval, production of these doses on a new filling line are already underway, and the doses are prepared to be shipped out. There is also an additional filling line that is expected to provide doses for this 2024/2025 season.
In other Beyfortus news, an observational study (NCT06030505) in a real-world setting surrounding the drug determined that it reportedly decreases the risk of hospitalized (RSV)-associated bronchiolitis in infants younger than 12 months of age.3-5
References
1. Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child. 1986;140(6):543-546.
2. Sanofi shipping BEYFORTUS in US to help protect babies against RSV disease; new manufacturing line approved by FDA. Sanofi. September 16, 2024. Accessed September 16, 2024. https://www.news.sanofi.us/2024-09-16-Sanofi-shipping-BEYFORTUS-R-in-US-to-help-protect-babies-against-RSV-disease-new-manufacturing-line-approved-by-FDA
3. Assad Z., et al. Nirsevimab and Hospitalization for RSV Bronchiolitis. N Engl J Med 2024;391:144-154. DOI: 10.1056/NEJMoa2314885. Vol. 391 No. 2.
4. Effectiveness of Nirsevimab in Children Hospitalised With RSV Bronchiolitis (ENVIE). ClinicalTrials.gov. April 19, 2024. Accessed July 11, 2024. https://clinicaltrials.gov/study/NCT06030505
5. James D. Real–World Data Show Efficacy of Beyfortus Against Hospitalization for RSV-Associated Bronchiolitis. Applied Clinical Trials. July 11, 2024. Accessed September 16, 2024. https://www.news.sanofi.us/2024-09-16-Sanofi-shipping-BEYFORTUS-R-in-US-to-help-protect-babies-against-RSV-disease-new-manufacturing-line-approved-by-FDA
