The US Food and Drug Administration (FDA) approved the Pfizer Inc and BioNTech coronavirus vaccine for children aged 5 to 11 years.
The US Centers for Disease Control and Prevention will be advising on how the shot should be administered, after a group of outside advisers discuss the plan on upcoming Tuesday November 2.
China, Cuba and the UAE have previously cleared COVID-19 vaccine for children in this age group and younger.
Pfizer said it will begin shipping pediatric vials of the vaccine on Saturday to pharmacies, paediatricians’ offices and other places where the shots may be administered.
The FDA decision is expected to make the vaccine available to 28 million American children, many of whom are back in school for in-person learning.
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.
Advisers on the FDA panel said a lower dose could help mitigate some of the rare side effects after paying close attention to the rate of heart inflammation, or myocarditis, that has been linked to both Pfizer and Moderna vaccines, especially in young men.
In the United States, around 58% of the population is fully vaccinated, lagging other nations such as the UK and France. Many adults, who have been hesitant to get a vaccine, may be more cautious about giving the shot to their children.
Pfizer and BioNTech said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.