Europe OKs 1-dose drug for babies against RSV

LONDON — The European Commission has authorized the world’s first one-dose drug against a respiratory virus that sickens millions of babies and children globally every year.

Drugmakers Sanofi and AstraZeneca said Friday that the European Commission had given the green light to nirsevimab, a laboratory-developed antibody designed to protect infants during their first exposure to RSV, or respiratory syncytial virus, a highly contagious common infection that infects nearly all babies by age 2.

At the moment, babies at high risk of the disease can be given monthly shots to protect them during RSV season.

In September, the European Medicines Agency recommended that nirsevimab, sold as Beyfortus, be authorized based on advanced research that showed the drug reduced the chances that babies with RSV would need medical attention and appeared to be safe, compared to infants who got a dummy treatment.

The drug is given in a single injection. “We are excited about the opportunity to expand prevention efforts to all infants,” said Silke Mader, co-founder of the European Foundation for the Care of Newborn Infants.

In the U.S., RSV is causing an early surge of infections in children’s hospitals this year.

European health officials are warning 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.

RSV kills about 100,000 babies annually, mostly in developing countries.

Earlier this week, Pfizer announced preliminary research showing that a new vaccine given to pregnant women could help protect their babies against RSV.