WASHINGTON -- Pfizer announced Friday that it submitted a request to the U.S. Food and Drug Administration to allow emergency use of its COVID-19 vaccine to children as young as 12.
This is the next step toward possibly beginning shots in this age group before they head back to school in the fall.
The FDA ask comes about one week after the company said its shot is safe and strongly protective in younger teens.
Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the coronavirus. Pfizer's vaccine is authorized for ages 16 and older. But vaccinating children of all ages will be critical to stopping the pandemic - and helping schools, at least the upper grades, start to look a little more normal after months of disruption.
In the vaccine study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given dummy shots, Pfizer reported.
Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
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