FDA Expected To OK Pfizer Vaccine For Ages 12-15 Within Week
FDA action could lead to the two-dose shots being available for younger teens before the beginning of the next school year.
The Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for kids ages 12 to 15 by next week, setting up shots for many before the beginning of the next school year.
That's according to a federal official and a person familiar with the process.
The FDA action would be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Then the Centers for Disease Control and Prevention would act on the committee’s recommendation. Those steps could be completed in a matter of days.
The two-dose Pfizer vaccine is currently authorized only for ages 16 and older.
Pfizer in late March released preliminary results from a study that showed its vaccine elicits "100% efficacy and robust antibody responses" in adolescents from 12 to 15 years old. The trial included 2,260 participants; the results are even better than earlier responses from participants ages 16 to 25.
At the time, Pfizer CEO and Chairman Albert Bourla called the results encouraging, adding that the company is acting "with the hope of starting to vaccinate this age group before the start of the next school year."
Information from NPR was used in this report.