Sep 28, 2021 - Health

Pfizer submits data to FDA on COVID-19 vaccine for younger kids

Picture of a child tightly closing his eyes and holding his mother's hand as a nurse gives him the COVID-19 vaccine
Christiana Neri, 38, holds her 13-year-old son Ivan Hernandez as Sequoia Hutton administers the Pfizer COVID-19 vaccine at a clinic held in Los Angeles. Photo: Irfan Khan/Los Angeles Times via Getty Images

Pfizer and BioNTech on Tuesday submitted initial data on their coronavirus vaccine for children aged 5 to 11 to the U.S. Food and Drug Administration.

Why it matters: Since the start of the school year, coronavirus infections among children have been increasing. Pediatric hospitals called for federal help earlier this month, warning that "there may not be sufficient bed capacity," per NPR.

What's next: The companies said that a formal submission to request emergency use authorization should be expected "in the coming weeks."

The big picture: Pfizer and BioNTech released data last week and said their vaccine is safe and effective in younger children.

  • The companies found that when children were given two doses, three weeks apart, they had comparable antibody responses to people between the ages of 16 and 26.
  • The doses were a third of the size of those given to people over 12.

Details: The company revealed that it was also studying the effect of the vaccine on children under the age of 5, who received an even smaller dose than children 5 to 11.

  • The specific data for this cohort is expected to be released "as soon as the fourth quarter of this year."

Go deeper: Pfizer coronavirus vaccine safe, effective in children, company says

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