The US health regulator on Friday authorised the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years, making it the first Covid-19 shot for young children in the United States.
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, reports Reuters.
It comes after a panel of advisers to the Food and Drug Administration (FDA) voted overwhelmingly to recommend the authorization on Tuesday.
An advisory panel to the US 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.
The FDA authorised a 10-microgram dose of Pfizer's vaccine in young children, lower than the 30 micrograms in the original vaccine for those age 12 and older.
Pfizer and BioNTech said their vaccine showed 90.7 per cent efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
The companies expect data from a clinical trial in children ages 2 to 4 years by year end.
The United States started vaccinating teens between ages 12 and 17 with the vaccine in May. Vaccination coverage among children in that age group is lower than in older groups, according to the CDC.
Pfizer's vaccine was the first to be authorised for emergency use in the United States in December last year for those aged 16 and older. It gained clearance for the 12 to 15 age group in May and was granted full US approval in August.