Nirsevimab and RSV: Long-Term High Hopes and Short-Term Cautious Optimism

Column Author and Editor: Chris Day, MD | Pediatric Infectious Diseases; Director, Transplant Infectious Disease Services; Medical Director, Travel Medicine; Assistant Professor of Pediatrics, University of Missouri-Kansas City School of Medicine; Clinical Assistant Professor of Pediatrics, University of Kansas School of Medicine

A new monoclonal antibody to prevent RSV, nirsevimab (Beyfortus), has been approved and recommended by the Advisory Committee on Immunization Practices (ACIP) for all infants less than 8 months of age entering their first RSV season and for at-risk children entering their second season. In this edition of the Link, Maria Martinez provides a summary of nirsevimab’s clinical efficacy data and indications for use. There is tremendous excitement surrounding this development, but with RSV season rapidly approaching, it is not yet clear that all eligible children will easily be able to access the medication. While the manufacturer does expect that nirsevimab will be available this coming RSV season, it is not clear from press releases, at least, that the supply will be adequate to meet demand. Concerns about availability were also expressed at a recent ACIP meeting (September 22, 2023). The President of the American Academy of Pediatrics, Sandy L. Chung, MD, FAAP, sent a letter to the director of the Centers for Disease Control and Prevention and the administrator of the Centers for Medicare and Medicaid services requesting the agencies to consider the financial and administrative burdens associated with this new product and particularly to promote equitable distribution and access. Specific requests include an increase in the newborn bundle payment to facilitate administration in hospital birthing centers, support for birthing centers to participate in the Vaccines for Children (VFC) program, rapid approval of a new administration code specifically for nirsevimab with encouragement to insurers to rapidly update their payment systems, reimbursement for immunization counseling in general, an increase in the VFC maximum regional charges for immunization (as well as an appeal to Congress to establish a minimum floor for Medicaid reimbursement for vaccine administration), and assistance to pediatric practices to allow flexible use their nirsevimab stock regardless of whether it is supplied by VFC or privately purchased.¹

Regardless of the ability of the manufacturer to meet demand or the government support made available, pediatricians, family practitioners, and other primary care providers who care for young children will need to make plans to provide nirsevimab (or if necessary due to shortages, continued use of palivizumab (Synagis) for high-risk infants) both in their practices and by collaborating with local birthing centers. As many eligible infants will have been born prior to RSV season, providers will need to make efforts to have nirsevimab available in primary care practices and have plans to identify infants eligible for nirsevimab. Find out your local birthing centers’ plans and help assure newborns will be provided nirsevimab easily and equitably.

Another exciting development in the prevention of hospitalization and lower respiratory tract disease (LRTD) due to RSV is the recent approval (August 21, 2023) of Respiratory Syncytial Virus Vaccine (Abrysvo) for use in pregnant individuals to prevent LRTD and severe LRTD in infants from birth through 6 months of age.² On September 22, ACIP voted to recommend seasonal administration (September through January in most of the United States) and availability through VFC for maternal RSV vaccine for pregnant people at between 32 and 36 weeks of gestation. Infants that are already protected by maternal vaccination (when RSV vaccine was given 14 or more days prior to birth) will generally not need to receive nirsevimab with some possible exceptions (some high-risk infants, infants who have lost maternal antibody due to cardiopulmonary bypass, mothers with HIV or other immunocompromising conditions) under proposed CDC guidance.³

References:

1. Chung, Sandy. (July 31, 2023). [Letter to CDC Director and CMS Administrator requesting help with the implementation of nirsevimab-alip (Beyfortus)]. Retrieved from https://downloads.aap.org/DOFA/AAP%20Letter%20to%20CDC%20CMS%20re%20Nirsevimab.pdf. AAP.org.
2. S. Food & Drug Administration. (August 21, 2023). FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants [Press release]. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants
3. National Center for Immunization and Respiratory Diseases. (2023, September 22). CDC.gov. Tdap vaccination in pregnant people to inform maternal RSV vaccine planning from https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-09-22/07-Mat-Peds-Jones-508.pdf.