ACIP Recommendations for Nirsevimab ― Provided by Sanofi Vaccines Medical Affairs
Posted about 2 years ago by Elaine Crain
I am writing to inform you that the Advisory Committee on Immunization Practices (ACIP) to the CDC met on August 3rd, 2023 to discuss and vote on recommendations for the use of nirsevimab, a recombinant human IgG1 kappa monoclonal antibody with anti-RSV activity, and its inclusion in the Vaccines for Children program.
Vote results were as follows:
- Infants aged <8 months born during or entering their first RSV season are recommended to receive one dose of nirsevimab (50 mg for infants <5 kg and 100 mg for infants ≥5 kg) Result- PASSED (unanimous)
- Children aged 8–19 months who are at increased risk of severe RSV disease and entering their second RSV season are recommended to receive one dose of nirsevimab (200 mg) Result- PASSED(unanimous)
- Vaccines for Children Resolution (with language consistent with above policy questions) Result- PASSED (unanimous)
A summary of topics discussed is below.
Implementation and plans for monitoring safety and effectiveness1
- Nirsevimab storage, handling, and administration is similar to other routine vaccines for children. It is administered as an intramuscular injection using a single-dose pre-filled syringe and can be administered simultaneously with other childhood vaccines.
- If nirsevimab is administered alone, suspected adverse events (AEs) are reported to MedWatch. If nirsevimab is administered simultaneously with any vaccine, suspected AEs are reported to the Vaccine Adverse Event Reporting System (VAERS); additional reporting to Medwatch not needed. A process is in place to capture misrouted reports. The FDA and CDC will both participate in monitoring safety reports and other safety data sources.
- CDC will monitor effectiveness of nirsevimab by leveraging existing vaccine effectiveness platforms throughout the season.
Clinical considerations2,3
- For infants born shortly before and during the RSV season, providers should target administration during the birth hospitalization or shortly after discharge, and by one week of age.
- For infants born before the RSV season, providers should target administration just before the start of the RSV season, such as during a scheduled well child visit.
- Based on pre-pandemic patterns, nirsevimab could be administered in most of the continental US from October through the end of March. Providers in jurisdictions with altered seasonality should consult state, local, or territorial guidance on timing of nirsevimab administration.
- The ACIP added American Indian and Alaska Native Children to those recommended by the AAP who are at increased risk of severe disease in children aged 8-19 months entering their second RSV season based on documented increased incidence of RSV-associated hospitalizations in these groups. Other risk factors include children with chronic lung disease of prematurity who required medical support any time during the 6-month period before the start of the second RSV season, severe immunocompromise, cystic fibrosis who have manifestations of severe lung disease or weight-for-length <10th percentile.
References
- ACIP Presentation. Peacock G. 3 Aug 2023. Nirsevimab: Implementation Considerations. (Link)
- ACIP Presentation. Jones J. 3 Aug 2023. Evidence to Recommendations Framework: Nirsevimab Updates. (Link)
- ACIP Presentation. Jones J. 3 Aug 2023. Proposed Clinical Consideration Updates for Nirsevimab. (Link)
Additional details on clinical considerations for the use of nirsevimab will be included in the MMWR publication that will be shared with you once available.
In the meantime, if you have any questions, please feel free to reach out to me.
Thank you,
Ferdaus Hassan