CDC, FDA Announce 77,000 Additional Doses for Nirsevimab as Infant Treatment of RSV

More than 77,000 additional doses of nirsevimab-aip 100 mg (Beyfortus; Sanofi), a long-acting monoclonal antibody for the prophylaxis of respiratory syncytial virus (RSV), will be distributed for the 2023-2024 RSV season, according to the CDC.¹

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Additional doses will immediately be distributed to physicians and hospitals through commercial channels and the Vaccines for Children Program, according to the press release. The CDC states that this should improve “the availability of nirsevimab-alip for parents seeking to protect their eligible children, particularly those at highest risk of severe illness.”¹

The statement added that both the CDC and FDA will continue to assess the availability of additional doses with manufacturers through the end of 2023 and early 2024 to meet the demand.¹

“Helping to ensure the availability of this preventative option to reduce the impact of RSV disease on eligible [infants] and young children, families, and the health care system remains a priority,” Patrizia Cavazzoni, MD, director of the Center for Drug Evaluation and Research at the FDA, said in the press release. “We will continue to use all our regulatory tools to help bring safe, effective and high-quality medicines to the public.”¹

In a recent study published in JAMA Network Open, in the 2022 RSV season, the majority of infants who had RSV and required intensive care were mostly delivered at full-term and were previously healthy, supporting the use of preventative methods and maternal vaccines. Additionally, infants less than 3 months old and those born prematurely were at highest risk for intubation.²

Furthermore, both agencies have spoken with organizations, including the American College of Obstetricians and Gynecologists, to emphasize the use of the maternal RSV vaccines, which can help protect infants before birth. The CDC also encourages physicians to prioritize nirsevimab-alip for infants at highest risk of RSV, according to the press release.¹

In October 2023, the CDC issued recommendations that addressed the limited supply of nirsevimab-alip, and Sanofi stated that an unprecedented demand for treatment has affected the supply for the 2023-2024 RSV season.³

The recommendations included the prioritization for infants aged less than 6 months and infants with underlying conditions for nirsevimab-alip in the 100 mg dosage, but the recommendation for the 50 mg dosage has not changed. However, the CDC does advise against 2 doses of 50 mg for infants that weigh 11 lbs or more to conserve the supply of 50 mg dosages. Further, although the American Academy of Pediatrics recommends the use of nirsevimab-alip and palivizumab for children aged 8 to 19 months, the CDC recommends stopping the use of nirsevimab-alip in treatment during the 2023-2024 RSV season.³

In August 2023, the CDC voted unanimously to recommend the use of nirsevimab-alip for the prevention of RSV lower respiratory tract disease for infants under 8 months of age or for infants in their first RSV season. Furthermore, they added that nirsevimab-alip should be used for those aged 8 to 19 months with an increased risk of RSV and are entering their second RSV season.Additionally, nirsevimab-alip was also voted to be included in the Vaccines for Children program in August 2023.⁴

References

1. CDC and FDA Expedite the Availability of Additional Doses of New RSV Immunization for Infants. News release. Centers for Disease Control and Prevention. November 16, 2023. Accessed November 17, 2023. https://www.cdc.gov/media/releases/2023/p1116-rsv-doses.html
2. Halasa N, Zambrano LD, Amarin JZ, Stewart LA, et al. Infants Admitted to US Intensive Care Units for RSV Infection During the 2022 Seasonal Peak. JAMA Netw Open. 2023;6(8):e2328950. doi:10.1001/jamanetworkopen.2023.28950
3. Pharmacy Times. CDC issues alert to address shortage of RSV treatment nirsevimab. October 24, 2023. Accessed November 17, 202. https://www.pharmacytimes.com/view/cdc-issues-alert-to-address-shortage-of-rsv-drug-nirsevimab
4. Pharmacy Times. CDC Advisory Committee on Immunization Practices recommends nirsevimab-alip to prevent RSV in infants. August 4, 2023. Accessed November 17, 2023. https://www.pharmacytimes.com/view/cdc-advisory-committee-on-immunization-practices-recommends-nirsevimab-alip-to-prevent-rsv-in-infants