Story at a glance

  • Pfizer CEO Albert Bourla said he expects clinical data on children’s COVID-19 vaccines to be ready by late October.
  • From there, the company will formally file for approval from the FDA.
  • Children are returning to school amid continued surges of COVID-19, prompting debates over mask mandates.

In the company’s continued efforts to achieve regulatory approval for a COVID-19 vaccination for kids, Pfizer said that the company still aims to provide clinical safety data on its vaccination effects among 6-month to 5-year-old children by late October.


Speaking Tuesday at Research!America’s 2021 National Health Research Forum, Pfizer CEO Albert Bourla said incoming data on young children’s immune responses to the company’s vaccine candidate should be ready in a little over a month.

“Then, it is up to the FDA to take their time, and then make a decision,” Bourla said during an interview, per CNBC.

His comments come at an especially charged time in the U.S.’s fight to vaccinate the vast majority of its population. Schools across the country are reopening for in-person learning, and given that no COVID-19 vaccine has been cleared for children under the age of 12, debates over mask mandates in schools have sowed divisions between municipalities and state governments.

A prime example has been in Florida, where Gov. Ron DeSantis (R) has vehemently opposed mask mandates and threatened local governments with penalties if they implement their own mask mandates.

Recently, an appeals court ruled in favor of DeSantis and reinforced his ban on local mask mandates. 

With momentum for vaccinations for children building, the U.S. Food and Drug Administration reassured Americans that while they are working hard to approve a vaccine for young children under the emergency use authorization, they are being “extremely meticulous” when analyzing safety data. 

Published on Sep 14, 2021