FDA Authorizes Emergency Use Pfizer Booster Shots for Kids Aged 12-15

The U.S. Food and Drug Administration on Monday approved the emergency use of Pfizer's booster shot against COVID-19 for youths aged 12 to 15.

The move comes as the Omicron variant spreads across the country and students return to classrooms following the holiday break.

"Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind," Acting FDA Commissioner Dr. Janet Woodcock said in an agency news release announcing the approval.

"With the current wave of the Omicron variant, it’s critical that we continue to take effective, lifesaving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19," Woodcock said.

The FDA also reduced the period that people must wait between their second dose and their booster shot to five months, down from the current six months. At the same time, regulators authorized the Pfizer booster shot for a select group of younger children, those ages 5 to 11 who have immune deficiencies and are therefore more vulnerable to severe COVID-19.

"The recent rise in COVID-19 cases is concerning to all and today's decision by the FDA to further expand the emergency use authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic," Pfizer Chairman and CEO Albert Bourla said in a company statement. "We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations."

Another FDA official noted that Omicron has made booster shots far more critical than first thought.

"Based on the FDA's assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants. In particular, the Omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

"With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals," Marks said in the FDA release.

Now, the U.S. Centers for Disease Control and Prevention’s vaccine advisory committee will meet Wednesday to vote on whether to recommend the changes, the Washington Post reported. The panel's vote would be followed by what is expected to be a quick endorsement from CDC Director Dr. Rochelle Walensky.

While children are believed to better tolerate infection with COVID-19, in rare cases they can become severely ill and die. As well, the highly contagious Omicron variant of COVID is infecting record numbers of Americans now, putting pressure on hospitals that are already caring for patients infected with the Delta variant, the New York Times noted.

Pfizer boosters had been authorized for people ages 16 and up. The two other COVID vaccines, from Moderna and Johnson & Johnson, are only authorized for adults 18 and up.

About 70% of Americans ages 12 and older are now fully vaccinated, according to the CDC, but about 1.8 million adolescents in the 12- to 15-year-old demographic have already tested positive for the virus.