Pfizer and BioNTech on Tuesday (April 26) officially submitted an application to the U.S. FDA for Emergency Use Authorization (EUA) of a 10-µg booster injection of the Pfizer-BioNTech COVID-19 Vaccine for children ages 5 through 11.
“Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in either individuals 12 years of age and older, or in individuals 5 through 11 years of age, as appropriate,” the companies press release stated.
They also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorization in the coming weeks.