The U.S. Food and Drug Administration on Friday authorized the Pfizer Inc (PFE.N) 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 shot will not be immediately available to the age group. The U.S. Centers for Disease Control and Prevention still needs to advise on how the shot should be administered, which will be decided after a group of outside advisers discuss the plan on Tuesday.
Pfizer said it will begin shipping pediatric vials of the vaccine on Saturday to pharmacies, pediatricians' 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. It comes after a panel of advisers to the regulator voted overwhelmingly to recommend the authorization on Tuesday.
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 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 after paying close attention to the rate of heart inflammation, or myocarditis, that has been linked to both Pfizer and Moderna (MRNA.O) vaccines, especially in young men.