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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 illness6-10. 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.11 Zainab 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, 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.5 It is a leading cause of hospitalisation in all infants, with most hospitalisations for RSV occurring in otherwise healthy infants born at term6-10. 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 requiring activation of the immune system. BEYFORTUS administration can be timed to coincide with the RSV season. BEYFORTUS has been approved for use in the European Union, the US, China, Japan, and many other countries around the world. Special designations to facilitate expedited development of BEYFORTUS were granted by several regulatory agencies, including Breakthrough Therapy Designation and Priority Review designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation and Fast Track Designation from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority MEdicines (PRIME) scheme and EMA accelerated assessment; Promising Innovative Medicine designation by the UK Medicines and Healthcare products Regulatory Agency; and BEYFORTUS has been named “a medicine for prioritized development” under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development. About the clinical trials The Phase 2b trial14 was a randomised, placebo-controlled trial designed to measure the efficacy of BEYFORTUS against medically attended lower respiratory tract disease (LRTD) caused by RSV through 150 days post-dose in healthy preterm infants of 29 to less than 35 weeks’ gestation (n=1,453). Infants were randomised (2:1) to receive a single 50 mg intramuscular injection of BEYFORTUS (n=969) or placebo (n=484) regardless of weight at the RSV season start. The primary endpoint was met, significantly reducing the incidence of medically attended RSV LRTD by 70.1% (95% CI: 52.3, 81.2; P<0.001) compared to