The Wall Street Journal: Pfizer’s COVID vaccine for kids might not get FDA approval until November


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.

That timeline for potential availability of the shots prompted parents, public health experts and vaccine experts to anticipate shots as early as October.

Pfizer may not finish its application until mid-October, however, which means the FDA may not make its decision until sometime between Halloween and Thanksgiving, according to the person familiar with the matter.

Pfizer submitted the data Tuesday and is on track to file a formal submission soon, a spokeswoman said.

An expanded version of this report appears on

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