The U.S. Food and Drug Administration reportedly is set to approve Pfizer/BioNTech’s coronavirus vaccine for adolescents ages 12 to 15 by early next week.
Pfizer, which obtained FDA’s emergency-use authorization for those 16 and older in December, has applied to amend the order to include youths 12 to 15 years old, a federal government official told CNN.
The official, who requested anonymity, said the process is largely a formality, CNN reported.
The FDA is reviewing data submitted by Pfizer, which said in late March that a clinical trial involving 2,260 12-to-15-year-olds showed a 100% efficacy rate and no major safety issues.
