- [ 메디채널 김갑성 기자 ] 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, Malaysia, Nov. 24, 2025 -- 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]
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."
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.
For more information and references, please visit this link: https://bit.ly/SanofiRSVENG.
