Last year the FDA approved both a monoclonal antibody (Beyfortus® [nirsevimab]) to be used in infants and a maternal RSV vaccine (AbrysoTM [RSVpreF vaccine]) (1,4). One year later, multiple real-world studies estimate nirsevimab to be 80-90% effective in preventing hospitalizations due to RSV-related lower respiratory tract infections (2,3).
As the 2024-2025 RSV season approaches, Partners for Kids continues to maintain a RSV Prevention Resource site to help prepare your practice for nirsevimab administration. Resources include supply, purchasing, and administration billing code information along with patient education material. A Partners For Kids RSV prevention webinar is set to take place on Thursday, September 12, 2024, from noon to 1p.m hosted by Dr. Pablo Sanchez a neonatologist and pediatric infection disease specialist at Nationwide Children’s Hospital.
Start date for administration of nirsevimab at Nationwide Children’s Hospital is October 1, 2024, in anticipation of the start of the RSV season on November 1, 2024 which typically lasts through March.
Who is eligible for nirsevimab?
ACIP/CDC and the American Academy of Pediatrics recommend one dose of nirsevimab for all infants < 8 months of age, born during or entering their first RSV season IF:
- Mother did NOT receive the RSVpreF vaccine during pregnancy or receipt is unknown
- Mother received RSVpreF vaccine < 14 days before delivery
In addition, infants may receive nirsevimab after maternal vaccination IF:
- Born to mothers who may not mount an adequate immune response to vaccination (e.g., immunocompromised) or have conditions associated with reduced transplacental antibody transfer (e.g., HIV-infection)
- Are at substantial risk for severe RSV disease (hemodynamically significant congenital heart disease, intensive care admission and requiring oxygen at discharge).
In general, infants in the neonatal intensive care unit will receive nirsevimab shortly before discharge. Per FDA, children who have received nirsevimab should not receive palivizumab in the same RSV season. Eligible infants may receive nirsevimab after an RSV infection, and nirsevimab can be co-administered with routine childhood vaccines.
Nirsevimab is also recommended for children 8 to 19 months old at increased risk for severe RSV disease during their 2nd season. These conditions include:
- Chronic lung disease of prematurity requiring medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the 6-month period before the start of the RSV season
- Severe immunocompromise
- Cystic fibrosis with severe lung disease (previous hospitalization for pulmonary exacerbation in 1st year of age, abnormal and persistent chest imaging, or weight-for-length <10%), or American Indian and Alaska Native children living in endemic areas.
For additional guidance please refer to the American Academy of Pediatrics Nirsevimab Administration Visual Guide.
What are the age and weight-based dosing recommendations?
Born during or entering their first RSV season:
Infants weighing < 5 kg: A single 50 mg dose by IM injection
Infants weighing 5 kg or greater: A single 100 mg dose by IM injection
Children at increased risk their second RSV season:
A single 200 mg dose by IM injection (two 100 mg syringes)
How can my practice obtain nirsevimab?
Nirsevimab is included in the Vaccines for Children (VFC) Program and therefore VFC-enrolled practices can obtain nirsevimab at no cost from the Ohio Department of Health for administration to uninsured and Ohio Medicaid insured patients. Please reach out to your Sanofi representative for purchasing nirsevimab stock for privately insured patients. A shortage of nirsevimab is not expected this coming season.
References:
- Jones et al. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72(34):920-925.
- Moline HL et al. MMWR Morb Mortal Wkly Rep. 2024 Mar 7;73(9):209-214.
- Ares-Gómez S et al. Lancet Infect Dis. 2024 Apr 30:S1473-3099(24)00215-9.
- Fleming-Dutra KE et al. MMWR Morb Mortal Wkly Rep. 2023 Oct 13;72(41):1115-1122.
- American Academy of Pediatrics. Respiratory Syncytial Virus (RSV) Prevention. Accessed from: https://www.aap.org/en/patient-care/respiratory-syncytial-virus-rsv-prevention/