The newly approved filling line will be able to provide both 50-mg and 100-mg doses of the respiratory syncytial virus antibody Beyfortus to help meet demand ahead of the 2024/2025 RSV season.
The FDA has given the green light to Sanofi and AstraZeneca’s new filling line for their respiratory syncytial virus antibody Beyfortus for newborns and infants (nirsevimab-alip), which will enable the companies to expand manufacturing capacity and meet demand in the U.S. for the coming season, according to Sanofi’s announcement on Monday.
The approval of the filling lines will allow the partners to deliver both 50-mg and 100-mg Beyfortus doses to private healthcare providers and to the Centers for Disease Control and Prevention for its Vaccines for Children program. Supplies of Beyfortus in the U.S. should be enough such that “every eligible baby” born off-season can receive immunization at a regular checkup, while all of those born during the season will be able to receive the antibody at birth.
Through AstraZeneca, which is responsible for Beyfortus development and manufacturing, several doses of the immunizing antibody have already been produced and packaged, according to Sanofi’s announcement. With Monday’s approval of the filling line, the companies are now “ready to ship” these doses and boost the supply in the Northern Hemisphere ahead of the 2024/2025 respiratory syncytial virus (RSV) season.
“This accomplishment aimed at equitable access was made possible through close partnership with the White House, Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and healthcare providers,” Thomas Grenier, head of vaccines, North America at Sanofi, said in a statement, noting that the newly approved filling line will help both the partners and health authorities make Beyfortus “widely available” to patients who need it.
Sanofi and AstraZeneca have another filling line that is also set to provide additional doses for the coming 2024/2025 season, according to the announcement.
Beyfortus is a long-acting antibody that facilitates passive immunity to RSV by targeting and binding to the part of the virus that it uses to enter host cells. Through this mechanism of action, Beyfortus can block RSV infection at a cellular level. In July 2023, the FDA signed off on the use of Beyfortus in infants entering their first RSV season and in children up to 24 months old who are at severe risk of infection in their second RSV season.
In March 2024, a CDC analysis showed that Beyfortus was highly effective in infants, demonstrating 90% efficacy at preventing RSV hospitalization. At the time, the agency noted that these data support its recommendation that “all infants should be protected by maternal RSV vaccination or infant receipt of nirsevimab.”
RSV vaccines are helping to prevent infection in adults. In May 2023, GSK’s Arexvy became the first FDA-approved RSV shot, indicated for adults aged 60 and above. The pharma expanded the label to cover younger seniors aged 50 to 59 in June 2024.
Pfizer is also competing in the RSV vaccine space with Abrysvo, which was first approved in June 2023. Abrysvo has since been expanded to allow pediatric immunization through maternal injection at 32 weeks to 36 weeks of gestation.
