The U.S. health regulator on Friday authorized 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.
It comes after a panel of advisers to the Food and Drug Administration (FDA) voted overwhelmingly to recommend the authorization on Tuesday.
The FDA authorized 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.
Advisers on the FDA panel said a lower dose could help mitigate some of the rare side effects.
At the meeting, they paid close attention to the rate of heart inflammation, or myocarditis, that has been linked to vaccines from both Pfizer/BioNTech and Moderna, especially in young men.
The regulator said on Friday that known and potential benefits of the Pfizer vaccine in individuals aged between 5 and 11 outweigh the risks.
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.
Pfizer and BioNTech said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
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 authorized 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 U.S. approval in August.
Shares of Pfizer were up 0.8%, while BioNTech was down 1.6% in late trading.