coronavirus

Pfizer CEO Says Covid Vaccine Data for Kids Under Age 5 May Come in Late October

John Thys | Pool | Reuters
  • Pfizer expects to release clinical trial data on how well its Covid-19 vaccine works in 6-month to 5-year-old children as early as the end of October, CEO Albert Bourla said Tuesday.
  • Covid vaccine data for kids between ages 5 and 11 will come much sooner, he said, potentially ready to be submitted to the FDA by the end of this month.
  • "Then, it is up to the FDA to take their time, and then make a decision," Bourla said.

Pfizer expects to release clinical trial data on how well its Covid-19 vaccine works in 6-month to 5-year-old children as early as the end of October, CEO Albert Bourla said Tuesday.

Covid vaccine data for kids between ages 5 and 11 will come much sooner, he said, potentially ready to be submitted to the Food and Drug Administration by the end of this month.

"Then, it is up to the FDA to take their time, and then make a decision," Bourla said during an interview at Research!America's 2021 National Health Research Forum.

The CEO's comments come as many parents say they are anxious to get their children vaccinated, especially as schools reopen and the highly contagious delta variant continues to spread. The strain has led to a surge in hospitalizations across the U.S., including among young kids who are currently ineligible to get the shots.

So far, the Pfizer-BioNTech coronavirus vaccine has been cleared by the FDA for people as young as 12, while Moderna's and Johnson & Johnson's vaccines have been authorized for adults.

On Friday, FDA officials said they were "working around the clock" to support the approvals of Covid vaccines for kids under age 12.

Dr. Peter Marks, the FDA's top vaccine regulator, said last month the agency would move as "swiftly" as possible on approving the shot for kids under 12 once the companies submit data.

"Currently, there are still trials ongoing and so the agency has to wait for the company to submit the data for those trials," he said Aug. 23. "We certainly want to make sure that we get it right."

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