The Food and Drug Administration has granted emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for people in the United States between the ages of 12 and 15 years old, CNN reports.
An advisory committee for the Centers for Disease Control and Prevention is scheduled to meet Wednesday to review the data provided by Pfizer, and make recommendations regarding use of the vaccine in the younger age group.
Pfizer reported that 2,260 people, ages 12 to 15, were subjected to clinical trials where participants were either given two doses of the vaccine or a placebo three weeks apart. It was discovered that the vaccine was highly effective at preventing symptomatic illness, while side effects mirrored what was previously seen in the 16- to 25-year-old age group. The only difference was that fevers appeared to be a slightly more common occurrence in 12- to 15-year-olds, a trend that Dr. Bill Gruber, senior vice president at Pfizer, said was consistent with observations from an earlier trial.
Pfizer’s vaccine was last authorized for use on people as young as 16 years old, while Moderna and Johnson & Johnson remain limited to those 18 and older. However, Moderna is expected to receive findings from its trials on 12- to 17-year-olds within the next few weeks.
In March, Pfizer and BioNTech began trials on children aged 5 to 11, but the scope of their study expanded last month to include participants as young as two years old. The company is expected to apply for emergency authorization use with the FDA in September.
Once they receive the final approval from CDC Director Dr. Rochelle Walensky, the Biden Administration plans on acting quickly on distribution efforts by making the vaccine available through pediatricians, family doctors, and local pharmacies.