Pfizer and BioNTech submitted an application to the FDA seeking full approval of their COVID-19 vaccine for children ages 12 to 15, the drugmakers said Dec. 16.
In their application, the drugmakers cited follow-up data from a phase 3 clinical trial involving 2,228 children, which showed two doses of the vaccine were 100 percent effective against COVID-19. Thirty symptomatic COVID-19 cases occurred during the trial, but all were among the placebo group.
The FDA granted the vaccine emergency use authorization for children ages 12 to 15 in May and fully approved it for everyone 16 and up in August.