Beyfortus (Nirsevimab) Now Available in Malaysia to Protect All Infants Against RSV Disease

Sanofi and AstraZeneca’s Beyfortus (Nirsevimab) is now approved by the National Pharmaceutical Regulatory Agency (NPRA) and is available for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants born during or entering their first RSV season.¹

RSV is predominantly seen in infants less than 1 year old and infected children below 2 years old had a high hospitalisation rate of 84.5%⁴. As a tropical climate country, RSV circulation in Malaysia is seen throughout the year with distinct peaks.^{4, 5}

RSV is a highly contagious virus that can lead to serious respiratory illness for infants. It is a leading cause of hospitalisation in all infants, with most hospitalisations for RSV occurring in otherwise healthy infants born at term^{4, 5}. RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 2017⁶.

According to Datuk Dr Zulkifli Ismail, Technical Chairman of Immunise4Life and former president of the Malaysian Paediatric Association, “In Malaysia, RSV remains a significant but under-recognised public health burden. Hospital data consistently show that the majority of infants admitted with RSV are full-term and generally healthy, which highlights the importance of preventive solutions that extend protection to all babies across the board. Broader awareness and stronger cross-industry collaboration will be critical in easing the burden RSV places on families and our healthcare system overall.”

“Today, Malaysia joins other countries worldwide where an innovative immunisation solution is now available to protect all infants against RSV. The approval of Beyfortus marks a critical step towards giving parents the ability to protect their babies during their first year of life, when they are most vulnerable to severe RSV disease. We are committed to working with stakeholders across the RSV care continuum to ensure seamless implementation and broad availability of this innovative preventive solution — because every baby needs protection. Our goal is simple: to help parents protect their babies, and give them peace of mind,” said Zainab Sadat, Vaccines General Manager, Sanofi Southeast Asia & India

The approval was based on results from the extensive Beyfortus clinical development programme spanning across broad infant population from pre-term, heathy full-term and those with underlying comorbidities. Across all clinical endpoints, a single dose of Beyfortus demonstrated high and consistent efficacy against RSV disease sustained for at least six months. Beyfortus was well tolerated with a favourable safety profile that was consistent across all clinical trials and real-world evidence. The overall rates of adverse events were comparable between Beyfortus and placebo and the majority of adverse events were mild or moderate in severity.

In temperate countries, the single administration of Beyfortus was developed to correspond with the beginning of the RSV season for babies born prior to the season or at birth for those born during the RSV season. In clinical trials, Beyfortus helped prevent RSV disease requiring medical care in all infant populations studied, including those born healthy, at term or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. RSV disease requiring medical care included physician office, urgent care, emergency room visits and hospitalisations.

For more information and references online: bit.ly/SanofiRSVENG

About Beyfortus

Beyfortus (nirsevimab) is an immunisation designed for all newborns and infants for protection against RSV disease through their first RSV season, including for those born healthy at term or preterm, or with specific health conditions.

With an extended half-life of 69 days, Beyfortus is a monoclonal antibody provided directly to newborns and infants as a single dose¹; offering protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system. A single dose of Nirsevimab is associated with high and sustained levels of neutralizing antibodies through 361 days post-dose with favourable safety profile⁷. Beyfortus administration can be timed to coincide with the RSV season.

Beyfortus has been approved for use in many countries around the world. Special designations to facilitate expedited development of Beyfortus were granted by several regulatory agencies.

Today, Beyfortus remains an option that can offer RSV protection designed for all infants with proven high, sustained efficacy, favourable safety and public health impact demonstrated in the real world. Beyfortus is well accepted by parents and providers. Beyfortus is supported by an unparalleled body of real-world evidence against RSV disease in all infants, including hospitalisations.

References

1. Beyfortus Product Prescribing Information for Malaysia. MY/BEY/0525/EU SMPC0425 pdf. Accessed Oct 2025

2. Munro APS, et al, (2025) 180-day efficacy of nirsevimab against hospitalisation for respiratory syncytial virus lower respiratory tract infections in infants (HARMONIE): a randomised, controlled, phase 3b trial. The Lancet Child & Adolescent Health, Volume 9, Issue 6, 404 – 412

3. DM Sumsuzzman, et al. (2025) Real-world effectiveness of nirsevimab against respiratory syncytial virus disease in infants: a systematic review and meta-analysis. Lancet Child Adolesc Health 2025; 9: 393–403 https://doi.org/ 10.1016/S2352-4642(25)00093-8

4. Low YL, r et al. (2022). Prevalence of respiratory viruses among paediatric patients in acute respiratory illnesses in Malaysia. PLoS ;17(8):e0265288. doi: 10.1371/journal.pone.0265288.

5. Toh TH, et al. (2019). High Prevalence of Viral Infections Among Hospitalized Pneumonia Patients in Equatorial Sarawak, Malaysia. Open Forum Infect Dis. 2019 Feb 13;6(3): ofz074. doi: 10.1093/ofid/ofz074.

6. Zhang S, et al. (2020) Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687

7. Wilkins, D, et al. (2024) RSV Neutralizing Antibodies Following Nirsevimab and Palivizumab Dosing. Pediatrics. 2024;154(5): e2024067174 DOI: https://doi.org/ 10.1542/peds.2024-067174

MAT-MY-2500520-1.0-10/2025