It has taken decades to overcome the many scientific and technical barriers that stopped us from being able to provide routine prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) to a broad population of babies, whether born before or during RSV season, at term or preterm, healthy or with existing medical conditions. Now that those hurdles have been cleared, we should not allow obstacles of our own making keep us from providing the protection that eligible babies need and deserve. Taking steps to provide immunization during the birth hospitalization and/or vaccinating pregnant women between 32 to 36 weeks of gestation are ways we can reach our goal.
A well-understood risk.
RSV has been a focus of my work for most of my 40-year career. It is a highly contagious, seasonal virus that causes potentially serious respiratory illness. While hospitalizations are generally uncommon, RSV is the leading cause of infant hospitalizations, according to the Centers for Disease Control and Prevention (CDC).1 RSV hospitalizations are also the highest in the first three to six months of life.2,3 This is an alarming fact for parents, families, and the physicians who care for them.
This is why RSV has been an important topic of study for pediatric infectious disease specialists. It has been well understood for decades that administration of antibodies to RSV could help provide passive immunity and lessen severity of disease – but we needed scientific advances to put that understanding to work in immunizing against RSV. Progress in molecular biology made it possible to create long-acting monoclonal antibodies for niche uses, and later discoveries confirming the optimal targets for these antibodies to help provide protection against a given virus opened the door to mass production of more precisely targeted antibodies for broad populations.
A long-awaited breakthrough.
The confluence of advances in biology and technology finally led to the development of the first and only U.S. Food & Drug Administration (FDA) approved long-acting monoclonal antibody for RSV LRTD protection, Beyfortus® (nirsevimab-alip) 50mg and 100mg Injection, a long-awaited option in this space.
Beyfortus is approved by the FDA to help prevent RSV LRTD in neonates and infants born during or entering their first RSV season and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients. Please see below for full Important Safety Information.
Pediatricians have been seeking something like this throughout my career working in hospitals.4 Immunization during the birth hospitalization prior to discharge for those born in or just before the start of RSV season, which is roughly from fall through spring, with some exceptions, such as in Florida and Hawaii, where the RSV season may start earlier,5 is how we should administer it. It can be our best strategy for helping protect as many infants as possible against this highly contagious virus.
More than 98% of mothers give birth in a hospital.6 This means hospitals and payers now have a vital opportunity to help protect vulnerable newborns born during the RSV season.
The right time and place to act.
RSV treatment and medically attended visits amount to $709.6 million in costs each year,7 imposing a significant financial burden on hospitals, payers, and parents.
Immunization during the birth hospitalization is the preferred way to give babies born during RSV season protection between discharge and their first office visit.8 Waiting to immunize until the newborn’s first pediatric office visit risks losing the chance to provide that protection during their first days of life. Hundreds of thousands of mothers and infants miss early recommended pediatric visits9 due to financial barriers and access challenges. This means that by choosing not to administer in the hospital, we may be putting disadvantaged families at increased risk of further burdens, potentially causing unintended gaps in health outcomes for our most vulnerable infants. If a baby is going home to a toddler sibling who may already be actively infected with RSV, for example, we are taking a needless chance. By ensuring administration during the birth hospitalization, we can help bridge this gap.
A straightforward solution.
Payers can include Beyfortus as a claims line item, averting the need for complex DRG (Diagnosis-Related Groups) recalibration or contract negotiations. This approach ensures a single payment, only when it is administered, avoids a higher DRG rate during non-RSV season, and reduces the risk of double payment. Most importantly, putting this policy in place now can provide immediate access to protection for hundreds of thousands of infants during this 2024-2025 season and establish a blueprint for the future.
Because Beyfortus is covered under the Vaccines for Children (VFC) program, infants covered by Medicaid may be able to receive doses at no cost to the hospital or the family. Hospitals recognize that providing at-birth immunization to all babies can be an effective way to advance health equity. Opening commercial access to in-patient immunization at birth through line-item billing would have the multiplier effect of access to more VFC doses for infants at risk due to certain social determinants of health.
The final hurdle.
It took the combined power of molecular biology and manufacturing technology to make routine prevention of RSV LRTD possible. Now we need the shared commitment of hospital systems and payers to overcome this barrier to providing this protection. Hospitals and payers can work together to bridge the health equity gap and help protect as many babies as possible – all by supporting at-birth immunization in the hospital prior to discharge.
We have been working toward this moment of protection against RSV LRTD in a broad population of infants for decades. It’s time to clear this hurdle of nursery dosing.
INDICATION
Beyfortus is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in:
- Neonates and infants born during or entering their first RSV season.
- Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
IMPORTANT SAFETY INFORMATION
Contraindication
Beyfortus is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients.
Warnings and Precautions
- Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions have been reported following Beyfortus administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.
- Use in Individuals with Clinically Significant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.
Most common adverse reactions with Beyfortus were rash (0.9%) and injection site reactions (0.3%).
Please see full Prescribing Information.
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Leonard Krilov, MD, FAAP, FIDSA, FPIDS, is a Pediatric Infectious Disease specialist and former Chairman, Department of Pediatrics, Professor of Pediatrics, and Chief, Division of Pediatric Infectious Disease at the NYU Grossman Long Island School of Medicine and NYU Langone Long Island Hospital in Mineola, NY and former Professor of Pediatrics at the State University of New York Stony Brook School of Medicine. Currently, he is a Fellow of the American Academy of Pediatrics, the Infectious Diseases Society of America, and the Pediatric Infectious Diseases Society. He is also an elected member of the Society for Pediatric Research and the American Pediatric Society. Dr. Krilov was compensated for his participation in this article.
1Centers for Disease Control and Prevention. (n.d.-b). RSV in infants and Young Children. Centers for Disease Control and Prevention. https://www.cdc.gov/rsv/infants-young-children/?s_cid=SEM.MS%3APAI%3ARG_AO_MS_TM_A18_RSV-Parents-Brd%3Arsv+vaccine+for+newborns%3ASEM00129&utm_id=SEM.MS%3APAI%3ARG_AO_MS_TM_A18_RSV-Parents-Brd%3Arsv+vaccine+for+newborns%3ASEM00129 (2024).
2Ramilo O, Mejia A. Measuring the burden of RSV in children to precisely assess the impact of preventive strategies. Pediatrics. 2020;146(1):1-2. doi: 10.1542/peds.202-1727
3Rha B, Curns AT, Lively JY, et al. Respiratory syncytial virus-associated hospitalizations among young children: 2015-2016. Pediatrics. 2020;146(1):e20193611. doi: 10.10542/peds.2019-3611
4 CDC. RSV Surveillance & Research. Centers for Disease Control and Prevention https://www.cdc.gov/rsv/research/index.html (2023).
5Rose, E. B., Wheatley, A., Langley, G., Gerber, S. & Haynes, A. Respiratory Syncytial Virus Seasonality - United States, 2014-2017. MMWR Morb. Mortal. Wkly. Rep. 67, 71–76 (2018).
6National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Division of Behavioral and Social Sciences and Education; Board on Children, Youth, and Families; Committee on Assessing Health Outcomes by Birth Settings; Backes EP, Scrimshaw SC, editors. Birth Settings in America: Outcomes, Quality, Access, and Choice. Washington (DC): National Academies Press (US); 2020 Feb 6. 1, Introduction. Available from: https://www.ncbi.nlm.nih.gov/books/NBK555491/
7Munro, A. P. S., Martinón-Torres, F., Drysdale, S. B., & Faust, S. N. (2023). The disease burden of respiratory syncytial virus in Infants. Current opinion in infectious diseases, 36(5), 379–384. https://doi.org/10.1097/QCO.0000000000000952
8CDC. RSV Immunization Guidance for Infants and Young Children. Centers for Disease Control and Prevention. https://www.cdc.gov/rsv/hcp/vaccine-clinical-guidance/infants-young-children.html (2024).
9Nelson CB, Brady BL, Richards M, et al. Optimal site of care for administration of extended half-life respiratory syncytial virus (RSV) antibodies to infants in the United States (US). Vaccine. 2023;41(40):5820-5824. doi: 10.1016/j.vaccine.2023.06.089