Regulatory clearance of the Pfizer Inc. and BioNTech SE vaccine for young children may not come until November, according to a person familiar with the matter, after the companies said they won’t ask for the green light for a few weeks.
The companies said Tuesday they provided U.S. health regulators with data from a recent study of their vaccine in children 5 to 11 years old. They said they would file an application asking the Food and Drug Administration to authorize use in the coming weeks, though they had previously targeted submitting the application as early as the end of September.