Pfizer Inc. and partner BioNTech SE have begun submitting data to U.S. regulators for authorization of their COVID-19 vaccine in children 6 months to 4 years old, according to people familiar with the matter, hastening an effort to get shots to younger kids after the omicron wave caused pediatric infections to jump.
The companies have begun the process of seeking an emergency-use authorization from the U.S. Food and Drug Administration for the vaccine in those under the age of 5, according to the people, who asked not to be named as the details aren’t public. The rolling submission of data paves the way for regulators to clear the shot as a two-dose vaccine, though it’s expected that ultimately a three-shot regimen may become standard.
Representatives from Pfizer couldn’t immediately be reached for comment. The White House declined to comment.
