“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” said acting FDA Commissioner Janet Woodcock.
Pfizer announced in late March that its clinical trials showed the vaccine was safe and 100% effective in children ages 12-15, similar to the 95% efficacy among adult clinical trial participants.
Pfizer’s vaccine was the first to show data in children as young as 12, a promising first step toward vaccinating younger Americans. The vaccine was the only option for those 16 and 17 and older in the U.S. with Moderna and Johnson & Johnson authorized for those 18 and older. Now, the FDA authorization means kids throughout middle and high schools will have the opportunity to be vaccinated before the fall, alleviating many of the hurdles schools face in stopping transmission.
Currently, about 115 million Americans are fully immunized — about 35% of the population.
After a trial with 2,260 children, Pfizer found no cases of infection among the children who had been given the vaccine and 18 cases of infection among the children who received a placebo. Real-world results often vary a bit from clinical trials.
According to Pfizer, the vaccine was also safe with adolescents experiencing a similar range of side effects as seen in older teens and young adults — generally seen as cold-like symptoms in the two to three days after the second dose.