The U.S. Food and Drug Administration (FDA) on Monday expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine boosters to children ages 12 to 15, as schools reopen amid a winter surge of new infections driven by the Omicron variant.
The FDA also shortened the time for booster shots from at least six months after completion of the initial series to at least five months, for everyone aged 12 and older.
The decision was based on FDA's review of real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.
The agency has determined that the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine to provide continued protection against COVID-19 and the associated serious consequences outweigh the potential risks in individuals ages 12 to 15.
The agency said that it found "no new safety concerns" following a booster shot in young teenagers, and that there were no new reports of two types of heart inflammation called myocarditis or pericarditis linked to the boosters.
The FDA also allowed for a third primary series dose for certain immunocompromised children 5 through 11 years of age.
"With the current wave of the omicron variant, it's critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19," said Acting FDA Commissioner Janet Woodcock in a statement.
The FDA actions are expected to be reviewed by the U.S. Centers for Disease Control and Prevention (CDC) later this week.
The decision came as the Omicron variant is spreading rapidly across the United States, leading to record high hospitalizations among younger people. Most of the severe cases are among the unvaccinated.
During the week of Dec. 22 to 28, an average of 378 children aged 17 and under were admitted to hospitals per day due to COVID-19, a 66.1 percent increase from the week before, and a new record for hospitalized children with COVID-19 since the start of the pandemic, according to CDC data.
Some school districts have moved to virtual learning again amid the surge of infections.
The United States is now averaging over 316,000 new cases each day, a record high since the onset of the pandemic in the country.
The federal administration has been urging vaccinated Americans to get boosters and the unvaccinated to be inoculated.