Nirsevimab International Recommendation

Nirsevimab is the 1^st RSV immunization designed for all infants1 including those born^*:

Healthy or underlying condition

Term or pre-term

During or before RSV season

Nirsevimabis indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season..¹

^*Beyfortus is contraindicated in infants with hypersensitivity to the active substance or to any of the excipients¹

Health Authorities are Recognizing the Need for RSV Prevention and the High Potential of Nirsevimab

Nirsevimab is setting a new precedent by achieving accelerated reviews, approvals, and preferential recommendations in many countries as the launch continues

NG: National Government
^a. All infants immunization is the preferential recommendation over maternal immunization
^b. As of 30 September 2024

2023:

1. O’Leary ST, Yonts AB, Gaviria-Agudelo C, Kimberlin DW, Paulsen GC. Summer 2023 ACIP Update: RSV Prevention and Updated Recommendations on Other Vaccines. Pediatrics. 2023; doi: 10.1542/peds.2023-063955
2. Nirsévimab, BEYFORTUS 50 et 100 mg, solution injectable en seringue préremplie, Primo-inscription Adopté par la Commission de la transparence le 19 juillet 2023
3. Ponencia de Programa y Registro de Vacunaciones
4. NIAC recommends RSV immunisation for infants and older adults (imt.ie) eurosurveillance-rsv-luxembourg-2023.pdf (public.lu)
5. Recomendación del CAVEI sobre incorporación de un anticuerpo monoclonal para inmunización pasiva contra virus respiratorio sincicial en lactantes en el ProgramaNacional de Inmunizaciones

2024:

1. Epidemiologisches Bulletin 26/2024 (rki.de)
2. onsensus statement - recommendation on the prevention of respiratory syncytial virus (RSV) infections with the monoclonal antibody Nirsevimab (Beyfortus^®).pdf
3. Immunisation-against-RSV-in-the-first-year-of-life-Summary.pdf
4. https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-statement-prevention-respiratory-syncytial-virus-disease-infants.html

Statement on the prevention of respiratory syncytial virus disease in infants - Canada.ca Valid as of May 17, 2024: The National Advisory Committee on Immunization's statement on the prevention of respiratory syncytial virus disease in infants.

All infants protection, using the EtR, the votes under consideration regarding nirsevimab were as follows ^1,2:

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)

Children aged 8 through 19 months who are at increased risk of severe RSV disease (per current AAP recommendations for infants recommended to receive palivizumab) and entering their second RSV season are recommended to receive one dose of nirsevimab (200 mg).

EtR; Evidence to Recommendations; RSV: Respiratory syncytial virus; AAP: American Academy of Pediatrics

Germany STIKO Recommendation on Nirsevimab for RSV Prophylaxis in Infants

The STIKO recommends RSV prophylaxis with the monoclonal antibody Nirsevimab (Beyfortus) as a single dose for all newborns and infants before or during their first RSV season   Newborns of any gestational age born during the RSV season should receive Nirsevimab as soon as possible after birth, ideally upon discharge from the maternity facility.   After examining the available evidence for MI, the STIKO concluded that the current data is insufficient to make a recommendation. Given the small study population and considering the suspension of a similar vaccine’s development due to preterm birth signals during pregnancy, reliable data are essential.

Paediatric population at high risk of developing serious disease from RSV infection, including: (a) preterm infants with <35 weeks gestational age (a single dose should be administered before 12 months of age);

Nirsevimab is recommended in children under 6 months of age born from 1 April 2023 until 31 March 2024. Priority will be given to immunise those born during the season and those born previously will be immunised as early as possible (October).

MAT-KW-2400553-V1-Dec 2024