The F.D.A. authorized AstraZeneca’s treatment to be given outside a health care setting, although it will still need a prescription.
The respiratory virus is a global killer of babies and young children.
Advisers to the agency overwhelmingly agreed that a new treatment would help to prevent a potentially lethal respiratory illness in very young children.
The shots would be the first vaccines available against a respiratory virus that kills thousands and leads to many more hospitalizations each year.
One expert said the blood-clotting syndrome was estimated to occur in one in 50,000 people under 40 and one in 100,000 over 40 who received AstraZeneca’s vaccine.
A new analysis examined deaths in Britain, where the company’s product was restricted in 2021 because of safety concerns.
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