- Beyfortus® (nirsevimab) is an available option designed to protect all infants – whether born full-term or pre-term, healthy or with underlying conditions – against respiratory syncytial virus (RSV), with proven high and sustained efficacy, a favourable safety profile, and real-world public health impact.1
- Administration can be timed during the first year of life to provide protection from birth, or as early as possible.1
- In the recent HARMONIE trial findings, Beyfortus reduced RSV hospitalisations in infants by 82.7% (95% CI: 67.8 to 91.5; p<0,0001) through six months (180 days).2
- Real world evidence from several national immunisation programs globally underscores the urgency for infant RSV prevention and reinforces the proven efficacy and favourable safety profile of Beyfortus against RSV disease and hospitalization in all infants.3
- Beyfortus has demonstrated high real-world effectiveness consistently exceeding 80% with high acceptance rate.3
KUALA LUMPUR, Nov 25 — 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
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 health care system overall.”
Zainab Sadat: Vaccines General Manager, Sanofi Southeast Asia & India
“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.”
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.
About RSV
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 term4, 5. RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 20176.
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 hospitalizations.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent health care, environmental, and societal challenges of our time.
For more information, visit www.sanofi.com.
References
- Beyfortus® Product Prescribing Information for Malaysia. MY/BEY/0525/EU SMPC0425 V_108026_20250610_125320_D3.pdf. Accessed Oct 2025
- 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
- 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
- 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.
- 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.
- 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
- 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
KKLIU 3697/EXP 16.05.2026
