FDA expected to authorize Pfizer vaccine for teens this week
The U.S. Food and Drug Administration (FDA) is expected to authorize the Pfizer and BioNTech novel coronavirus (COVID-19) vaccination for adolescents ages 12 to 15 years old sometime this week, the Associated Press (AP) reports. The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.
A federal official, speaking on the condition of anonymity to preview the FDA’s action, told the AP that the agency was expected to expand its emergency use authorization for the two-dose vaccine by early next week, if not sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline, the AP said. The New York Times first reported on the expected timing for the authorization yesterday.
The news follows results published in late March, which showed 100 percent efficacy and robust antibody responses in adolescents ages 12 to 15 years old. The phase 3 trial included 2,260 adolescents ages in the United States and demonstrated strong immunogenicity in a subset of adolescents one month after the second dose.
A federal vaccine advisory committee is expected to meet this week and discuss whether to recommend the shot for 12- to 15-year-olds. Vaccine administration could begin shortly after the U.S. Centers for Disease Control and Prevention adopts the committee’s recommendation, which could be completed this week.