NEW YORK - Pfizer-BioNTech has submitted data to the U.S. Food and Drug Administration from the late-stage trial of its COVID-19 vaccine in children ages 5 to 11, saying the companies expect to formally submit a request for emergency approval in "the coming weeks."The Phase 2/3 trial data, collected from more than 2,2600 participants, will be reviewed by the FDA.
A formal submission to request emergency use authorization of the companies’ COVID-19 vaccine is expected to follow in the coming weeks, company officials said.The Pfizer COVID-19 vaccine is currently available in the U.S.
for those 12 and older, leaving many younger children still vulnerable amid the rapid spread of the delta variant of the coronavirus.