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Europe OK's 1st one-dose drug to protect babies against RSV

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

By AP News
Published - Nov 04, 2022, 11:54 AM ET
Last Updated - Jun 23, 2023, 07:33 PM EDT

LONDON (AP) — 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.

In a statement Friday, drugmakers Sanofi and AstraZeneca said 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 needed medical attention and appeared to be safe, compared to infants who got a dummy treatment. The drug is given in a single injection.

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