The Food and Drug Administration had urged Pfizer and its
partner BioNTech to apply for authorization of extra-low doses of its vaccine
for the youngest children before studies were even finished — citing the toll
the omicron variant has taken on children.
Next week, FDA advisers were supposed to publicly debate if
youngsters should starting getting two shots before it’s clear if they’d
actually need a third.
But Friday, the FDA reversed course and said it had become
clear it needed to wait for data on how well that third shot works for this age
group. Pfizer said in a statement that it expected the data by early April.
FDA’s vaccine chief Dr. Peter Marks said he hoped parents
would understand that the decision to delay was part of the agency’s careful review
and high scientific standards.
“We take our responsibility for reviewing these vaccines
very seriously because we’re parents as well,” Marks told reporters during a
teleconference.
Pfizer’s early data showed two of the extra-low doses were
safe for kids under 5 and strong enough to give good protection to babies as
young as 6 months. But once tots reached the preschool age -- the 2- to
4-year-olds -- two shots didn’t rev up enough immunity.
And a study of a third dose isn’t finished yet -- meaning
the FDA was considering whether to authorize two shots for now with potentially
a third cleared later, something highly unusual.
Friday, the FDA didn’t say exactly what new data Pfizer was
providing except that it involved the critical issue of a third dose.
“We believe additional information regarding evaluation of a
third dose should be considered as part of our decision-making,” the agency
said in a statement.
The nation’s 18 million children under 5 are the only age
group not yet eligible for vaccination.
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