Johannesburg – Sanofi has announced that the South African Health Products Regulatory Authority (SAHPRA) granted registration for a long-acting monoclonal antibody (mAb) designed to protect infants against Respiratory Syncytial Virus (RSV).
The RSV is 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,” Sanofi said in a statement released earlier this week.
“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 underfive years suffer from severe RSV illness, and around one in seven newborns under 1 month old are hospitalised with severe disease.
Nearly one in three lung infections in infants are caused by RSV, with symptoms ranging from mild colds to serious lung infections1.
In the first six months of life, RSV is linked to about 22% (around 2 in 10) of all baby hospital admissions.
“Each year, thousands of families are affected when babies fall ill during the February to May RSV season,” said 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,” said Bregeon.
“The launch of this medicine will help reduce serious RSV illness and keep more babies out of hospital.”
Sanofi said it encourages parents to act early and speak to their healthcare provider about the effective protection for their babies ahead of the RSV season.
