FDA Won’t Authorize COVID Vax for Children Under 5

Lack of information “made us realize that we needed to see data from a third dose from the ongoing trial in order to make a determination,” says FDA chief.

QUICK FACTS:
  • On Friday, the U.S. Food and Drug Administration abruptly put the brakes on their efforts to speed review of COVID-19 vaccinations for children under 5 that Pfizer has been testing, according to The Associated Press.
  • The U.S. regulator had taken the extraordinary step of urging Pfizer to apply for the OK.
  • The agency’s plan would have allowed vaccinations to begin within weeks.
  • FDA reversed course because it had become clear the agency needed to wait for data on how well or poorly a third shot works for the youngest age group.
  • “I think they made the right decision to be careful and wait for the third-dose data,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.
  • Pfizer said in a statement that it expected the data by early April, AP notes, but even if Pfizer completes its submission by early April, it will take the FDA and other health authorities several weeks to review and publicly vet the data.
WHAT THE FDA’S VACCINE CHIEF SAID:
  • FDA’s vaccine chief Dr. Peter Marks said the agency’s decision was part of its careful scientific review of the evidence Pfizer has submitted so far.
  • That information “made us realize that we needed to see data from a third dose from the ongoing trial in order to make a determination,” Marks told reporters. “We take our responsibility for reviewing these vaccines very seriously because we’re parents as well.”
BACKGROUND:
  • There 18 million children under 5 in America, the only age group not yet eligible for vaccination.
  • A Kaiser Family Foundation poll taken last month found just 3 in 10 parents of children under 5 would get their youngster vaccinated as soon as shots were authorized, about a quarter stating they definitely would not.

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