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COVID-19 vaccines for kids: What you need to know

How did the FDA determine the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine for use in kids ages 12 through 15?

The FDA reviewed a study of more than 2,200 U.S. children ages 12 through 15. Of this group, about half were given the Pfizer-BioNTech COVID-19 vaccine. The other children were given an inactive (placebo) shot.

A week after the second dose was given, research showed no cases of COVID-19 in the 1,005 children given the Pfizer-BioNTech vaccine. Among 978 children given the placebo, there were 16 cases of COVID-19. None of the children had previously been diagnosed with COVID-19. The results suggest that the vaccine is 100% effective at preventing COVID-19 in this age group.