The Food and Drug Administration (FDA) is set to authorize Pfizer's COVID-19 vaccine for children 12-to-15-years-old by early next week, a federal government official told The Associated Press, a pivotal step for getting shots in the arms of kids ahead of the next school year in the fall.
Pfizer and BioNTech, which developed the vaccine, announced last month that they were applying to the FDA for Emergency Use Authorization following promising results from its Phase 3 trial in adolescents. Pfizer announced in March that its vaccine "demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old."
The Pfizer-BioNTech vaccine is currently approved for use in individuals 16 years and older.
Vaccinating children of all ages will be critical to stopping the pandemic — and helping schools, at least the upper grades, start to look a little more normal after months of disruption. The other two coronavirus vaccines currently approved for emergency use in the United States, from Johnson & Johnson and Moderna, are approved for use in people 18 years and older.
The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.
In the vaccine study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given dummy shots, Pfizer reported.
"These submissions represent a critical step in Pfizer’s and BioNTech’s ongoing efforts to support governments in broadening global vaccination efforts," the request read in part. "The companies look forward to working closely with the U.S. Food and Drug Administration (FDA) and other worldwide regulatory authorities as part of the companies’ efforts to expand emergency or conditional authorization of their COVID-19 vaccine in 12- to 15-year-olds as quickly as possible."
Kids had side effects similar to young adults, Pfizer said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
Pfizer isn’t the only company seeking to lower the age limit for its vaccine: Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12-to-17-year-olds.
But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as 6 months old.
U.S.-based company Novavax announced earlier Monday that it has expanded its late-stage trial on its COVID-19 vaccine to include adolescents between the ages of 12-17, and will include up to 3,000 adolescents aged 12-17 in its Phase 3 clinical trial.
While COVID-19 vaccinations are not required to reopen schools, vaccinating children could go a long way toward getting kids and teachers back into classrooms nationwide.
The news was first reported by the New York Times.
The Associated Press contributed to this report.