• Beyfortus (nirsevimab) is the only 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.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, 3}
• Administration can be timed during the first year of life to protect from birth, or as early as possible.

SINGAPORE - Media OutReach Newswire - 5 September 2025 - The Health Sciences Authority (HSA) has approved Sanofi and AstraZeneca’s BEYFORTUS (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Globally, around 2 in 3 babies will catch RSV before their first birthday⁴ and it remains the most common cause of lower respiratory tract disease, including bronchiolitis and pneumonia, in infants⁵. RSV is also a leading cause of hospitalisation among infants in Singapore, with most cases occurring in otherwise healthy, full-term babies. Each year, approximately 1,804 children under 29 months are hospitalised due to RSV-related illness^6-10. A panel of leading paediatricians in Singapore recently published an expert consensus, underscoring the urgent need for RSV protection in all infants. They concur that nirsevimab is key to alleviating the RSV burden on the healthcare system and recommend that immunisation be considered for all infants under the National Immunisation Programme in Singapore.¹¹Zainab Sadat, Head of Vaccines, Sanofi Southeast Asia & India “Today, Singapore 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 three pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of BEYFORTUS demonstrated high and consistent efficacy against RSV disease sustained for at least five months. BEYFORTUS was well tolerated with a favourable safety profile that was consistent across all clinical trials. 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, BEYFORTUShelped 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.⁵ It is a leading cause of hospitalisation in all infants, with most hospitalisations for RSV occurring in otherwise healthy infants born at term^6-10. Two out of three infants are infected with RSV during their first year of life and almost all children are infected by their second birthday⁴. Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalisations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years¹². RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care — were estimated at €4.82 billion in 2017¹³. About BEYFORTUS BEYFORTUS (nirsevimab) is the first 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. It is also indicated for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. As a long-acting antibody provided directly to newborns and infants as a single dose, BEYFORTUS offers rapid protection to help prevent lower respiratory tract disease caused by RSV without...