US health regulators are expected to authorize a booster shot of Pfizer/BioNTech's Covid-19 vaccine for children aged 5 to 11 as soon as Tuesday, the New York Times reported on Monday, citing people familiar with the matter.
The companies submitted an application to the U.S. Food and Drug Administration for the authorization last month.
They have cited data from a mid- to late-stage study showing a third dose of their shot increased protection against the original coronavirus version and the Omicron variant among children in the age group.
It is unclear how much demand there is for the third dose in the age group. Just 28.8% of children aged 5 to 11 are fully vaccinated, according to data from the US Centres for Disease Control and Prevention.
A meeting of outside vaccine experts on an advisory committee to the Centers for Disease Control and Prevention has been scheduled for Thursday, the report said.
The FDA declined to comment, while Pfizer and BioNTech did not respond to requests for comment.