LONDON (AP) — The European Commission has approved the world’s first single-dose drug against a respiratory virus that sickens millions of babies and children worldwide every year.
In a statement Friday, drug makers Sanofi and AstraZeneca said the European Commission had given the green light to nirsevimab, a lab-developed antibody designed to protect infants during their first exposure to RSV, or respiratory syncytial virus, a highly contagious common infection. affecting almost all babies at age 2.
At this time, babies at high risk for the disease can receive monthly injections to protect them during the RSV season.
In September, the European Medicines Agency recommended the authorization of nirsevimab, sold as Beyfortus, based on advanced research showing that the drug reduced the likelihood that babies with RSV needed medical attention and appeared to be safe, compared with infants who received a sham treatment. The drug is given in a single injection.
“We are excited about the opportunity to extend prevention efforts to all babies,” said Silke Mader, co-founder of the European Foundation for the Care of Newborn Infants.
In the US, RSV is causing an early wave of infections in children’s hospitals this year. European health officials warn there could be a similar spike across the continent.
For most healthy people, RSV is a cold-like nuisance. But the virus can be life-threatening for the very young and the elderly. The virus can infect deep in the lungs and in small babies it can impede breathing by inflaming their small airways.
RSV kills about 100,000 babies every year, mainly in developing countries.
Nirsevimab is designed to give newborns and infants immediate protection against RSV by using an antibody to prevent infections in their respiratory tract.
Earlier this week, Pfizer announced: preliminary research showing a new vaccine given to pregnant women could help protect their babies from RSV, after decades of failing to develop an effective injection.