CDC Advisory Committee on Immunization Practices Recommends Nirsevimab-alip to Prevent RSV in Infants

The CDC Advisory Committee on Immunization Practices (ACIP) voted unanimously 10 to 0 to recommend the routine use of nirsevimab-alip (Beyfortus; Sanofi and AstraZeneca) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants under 8 months of age born during or entering their first RSV season.¹

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Further, ACIP voted unanimously to recommend routine use of nirsevimab-alip in infants from 8 to 19 months of age with an elevated risk of severe RSV who are entering their second RSV season. The committee also voted unanimously to include nirsevimab-alip in the Vaccines for Children program. The vaccine is expected to available in the United States ahead of the upcoming RSV season.

“Today, we have turned the corner on the threat of RSV to our youngest, most vulnerable population,” said Thomas Triomphe, executive vice president, Vaccines, Sanofi, in a press release. “The ACIP’s unanimous recommendations for routine use of Beyfortus and inclusion in the Vaccines for Children program are critical steps toward providing millions of parents in the US with the ability to protect their babies through their first RSV season, when they are most susceptible to severe RSV disease. We appreciate the FDA and CDC leadership, as well as the ACIP public health experts, for recognizing and quickly acting on the threat RSV poses to all infants.”¹

In July 2023, nirsevimab-alip was approved for the prevention of RSV-associated lower respiratory tract disease in neonates and infants born during or entering the first RSV season, and in children up to 2 years of age who remain vulnerable to severe RSV disease through their second RSV season.²

In most parts of the United States, circulation of RSV begins during the fall and peaks in the winter. It is transmitted through close contact with someone who is infected. Although most infants and young children experience mild, cold-like symptoms, some infants can develop lower respiratory tract disease, such as pneumonia and bronchiolitis, particularly during their first infection. This often leads to a visit to the emergency department or physician.²

Premature infants, particularly those with chronic lung disease related to prematurity or significant congenital heart disease, are at the highest risk for severe RSV disease. Approximately 1% to 3% of children under 12 months of age are hospitalized each year due to RSV, according to data from the American Academy of Pediatrics.²

Nirsevimab-alip is a monoclonal antibody with activity against RSV. A single dose, administered as a single intramuscular injection prior to or during RSV season, may provide protection.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 2 years, our community of pediatric-focused nurse practitioners welcomes the recent approval of nirsevimab,” said Regena Spratling, PhD, RN, APRN, CPNP-PC, FAANP, FAAN, president, National Association of Pediatric Nurse Practitioners, in a press release. “Today’s 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

The ACIP recommendations will be sent to the director of the CDC and the Department of Health and Human Services for review and approval and will be published in the CDC’s Morbidity and Mortality Weekly Report. If approved, the routine use of nirsevimab will be included in the CDC’s Child and Adolescent Immunization Schedule.

Reference

1. U.S. CDC Advisory Committee unanimously recommends routine use of Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease. Sanofi. News release. August 3, 2023. https://www.news.sanofi.us/2023-08-03-U-S-CDC-Advisory-Committee-unanimously-recommends-routine-use-of-Beyfortus-TM-nirsevimab-alip-to-protect-infants-against-RSV-disease

2. FDA Approves New Drug to Prevent RSV in Babies and Toddlers. News release. FDA. July 17, 2023. Accessed July 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers