FILE PHOTO: A vial labelled with the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/File Photo/File Photo
The U.S. drug regulator is expected to authorize the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years on Friday, the New York Times reported, citing people familiar with the agency's planning.
The U.S. Food and Drug Administration's decision will make it the first COVID-19 shot for young children in the United States.
The FDA did not immediately respond to Reuters request for comment.
The decision is expected to make the vaccine available to 28 million American children - many of whom are back in school for in-person learning - in the coming days. It comes after a panel of advisers to the FDA voted overwhelmingly to recommend the authorization on Tuesday.
An advisory panel to the U.S. Centers for Disease Control and Prevention (CDC) is scheduled to meet next week to consider recommendations on how the vaccine should be used in that age group. The CDC director will have the final say.
Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger.
Pfizer and BioNTech said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
