Beyfortus (Nirsevimab) Now Available in Malaysia to Guard Infants Against RSV
Infants in Malaysia can now be protected against respiratory syncytial virus (RSV) with the recently approved Beyfortus.
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Reported by Malay Mail
Tuesday, December 16, 2025, 11:59 AM MYT
Kuala Lumpur — Sanofi and AstraZeneca’s Beyfortus (Nirsevimab) has received approval from Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) and is now available to prevent RSV lower respiratory tract disease in newborns and infants during their first RSV season, including those born during the season or entering it.
RSV primarily affects children under one year, and infections in children under two years old were associated with a high hospitalization rate of 84.5%. In Malaysia’s tropical climate, RSV activity occurs year-round with noticeable peaks.
Datuk Dr Zulkifli Ismail, Technical Chairman of Immunise4Life and former president of the Malaysian Paediatric Association, noted, “In Malaysia, RSV remains a substantial yet under-appreciated public health burden. Hospital data consistently show that the majority of RSV hospitalizations occur in full-term and generally healthy infants, underscoring the need for preventive measures that protect all babies, broadly speaking.” He added that expanding awareness and stronger collaboration across sectors will be essential to reducing the impact of RSV on families and the healthcare system.
Zainab Sadat, Vaccines General Manager for Sanofi Southeast Asia & India, commented, “Today, Malaysia joins other countries where an innovative immunisation option is now available to shield all infants from RSV. The Beyfortus approval marks an important milestone, giving parents a means to safeguard their babies during the first year of life when they are most vulnerable to severe RSV disease.” She emphasized Sanofi’s commitment to coordinating with stakeholders across the RSV care continuum to ensure smooth implementation and wide access to this preventive solution, because every baby deserves protection. The overarching aim is to help parents safeguard their babies and provide peace of mind.
The decision to approve Beyfortus was supported by extensive clinical development data covering a broad infant population, including pre-term babies, healthy full-term infants, and those with underlying health conditions. Across all studied endpoints, a single Beyfortus dose offered high and durable protection against RSV for at least six months. The product was generally well tolerated, with a safety profile consistent across trials and real-world experience. Adverse events occurred at similar rates to placebo, and most were mild to moderate in severity.
In temperate regions, Beyfortus is administered as a single dose timed to align with the RSV season—either at birth for babies born during the season or before the season begins for those born beforehand. Clinical trials demonstrated that Beyfortus reduced RSV disease requiring medical care across all infant groups studied, including healthy term infants, preterm infants, and those with health conditions that heighten risk for severe RSV.
RSV is an extremely contagious virus that can cause serious respiratory illness in infants and is a leading cause of hospitalization for this age group, even among otherwise healthy term infants.
For more information and references, please visit: https://bit.ly/SanofiRSVENG
MAT-MY-2500520-1.0-10/2025
KKLIU 3697/EXP 16.05.2026
