Johannesburg, 29 January 2026: Sanofi today announced that the South African Health Products Regulatory Authority (SAHPRA) has granted registration for a long-acting monoclonal antibody (mAb) designed to protect infants against Respiratory Syncytial Virus (RSV), one of the leading causes of serious lower respiratory tract infections (LRTIs) such as bronchiolitis and pneumonia in babies.
This is an important step for RSV prevention in South Africa. It means more families will have access to new solutions that can help reduce hospital stays for babies, and the impact RSV has on them. Now that it is registered, the long-acting monoclonal antibody is expected to be available before the 2026 RSV season, supporting South Africa’s efforts to improve the health of mothers and babies.
RSV is a common seasonal virus that spreads easily and can cause serious illness in babies, often leading to hospital stays. In South Africa, the RSV season usually runs from February to May, although infections can happen at any time of the year1. During this period, many babies and young children become infected. Symptoms can range from mild, cold-like illness to serious lung infections that affect either the upper airways (nose and throat) or the lower airways (lungs)1.
Every year, about 96,000 babies under 5 years suffer from severe RSV illness, and around 1 in 7 newborns under 1 month old are hospitalised with severe disease2. Nearly 1 in 3 lung infections in infants are caused by RSV, with symptoms ranging from mild colds to serious lung infections1. In the first 6 months of life, RSV is linked to about 22% (around 2 in 10) of all baby hospital admissions3.
“Each year, thousands of families are affected when babies fall ill during the February to May RSV season,” says Jean-Baptiste Bregeon, Head of Vaccines and Country Lead at Sanofi South Africa. “Our goal is to help parents and healthcare providers protect every baby, not only those considered high risk, by ensuring timely access to effective prevention during this vulnerable period. Protecting babies before their first RSV season can help reduce emergency visits and hospital stays.”
Most babies hospitalised with RSV are otherwise healthy and born at term, which is why experts note that prevention strategies for all infants could have the greatest impact4+5. “RSV places a significant burden on South African families and the healthcare system every year,” says Bregeon. “The launch of this medicine will help reduce serious RSV illness and keep more babies out of hospital.”
We encourage parents to act early and speak to their healthcare provider about the effective protection for their babies ahead of the RSV season.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and creating 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 healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
References
- National Institute for Communicable Diseases (NICD). Respiratory Syncytial Virus (RSV). Available at: https://www.nicd.ac.za/diseases-a-z-index/respiratory-syncytial-virus-rsv/
2. Moyes J et al. The burden of RSV-associated illness in children aged < 5 years, South Africa, 2011 to 2016. BMC Med21, 139 (2023).
3. Wedderburn CJ et al. Risk and rates of hospitalisation in young children: A prospective study of a South African birth cohort. PLOS Glob Public Health. 2024
4. Zar HJ et al. Burden of RSV-associated lower respiratory tract infection among infants in a South African birth cohort. Lancet Glob Health. 2020.
5. Zar HJ et al. Burden of RSV in infants attending emergency departments in South Africa. PLoS ONE. 2024.
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