Nirsevimab-alip Gets Unanimous ACIP Recommendation to Prevent RSV in Neonates, Infants

On August 3, 2023, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) considered proposed recommendations for routine use of nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.

The ACIP voted in unanimous fashion, 10 to 0, to recommend routine use of nirsevimab-alip for newborns and infants younger than 8 months, born during or entering their first RSV season according to a press release from Sanofi^.1

The ACIP additionally voted 10 to 0 recommending routine nirsevimab-alip use for children aged 8 to 19 months that are at an increased risk of severe RSV disease while entering their second RSV season.¹

The announcement follows the American Academy of Pediatrics recommending that federal leaders rapidly implement changes that are needed to make sure all children have access to the recently FDA-approved vaccine.²

“As front-line providers managing the physical and emotional toll of RSV on our patients and their families, especially during the surges of the last two years, our community of pediatric-focused nurse practitioners welcomes the recent approval of nirsevimab,” said Regena Spratling, PhD, RN, CPNP-PC, FAANP, FAAN, president, National Association of Pediatric Nurse Practitioners. “[The] ACIP vote to include nirsevimab in routine immunization schedules, along with continued efforts to educate the public about the impact of RSV prevention, will help ensure equitable access to this immunization and help alleviate the strain RSV disease places on babies, families, and health care systems.”1

Nirsevimab-alip was approved by the FDA on July 17, 2023, which followed a 21 to 0 vote of support from the FDA Antimicrobial Drugs Advisory Committee on June 9, 2023. Nirsevimab-alip demonstrated an 83.21% reduction in RSV-related hospitalization in infants under 12 months in the phase 3b HARMONIE study.

The ACIP also voted 11 to 0 to include nirsevimab-alip in the Vaccines for Children (VFC) program and noted that the vaccine will be available ahead of the RSV season this year.¹

According to Sanofi, the ACIP recommendations will be forwarded to the CDC and US Department of Health and Human Services director for review and approval. After approval, use of nirsevimab-alip would be included in the CDC’s Child and Adolescent Immunization Schedule.

References

1. US CDC Advisory Committee unanimously recommends routine use of Beyfortus (nirsevimab-alip) to protect infants against RSV disease. Sanofi. Press release. August 3, 2023. Accessed August 3, 2023. https://www.sanofi.com/en/media-room/press-releases/2023/2023-08-03-19-21-36-2718475
2. AAP to federal leaders: Immediate support needed for pediatric practices to ensure all children can benefit from new RSV product. American Academy of Pediatrics. Press release. August 1, 2023. Accessed August 3, 2023. https://www.aap.org/en/news-room/news-releases/aap/2023/aap-to-federal-leaders-immediate-support-needed-for-pediatric-practices/