Peter Marks Washington covid-19 vaccine Peter Marks Washington

FDA postpones advisory meeting on COVID-19 vaccines for kids under 5

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WASHINGTON (AP) - U.S. regulators on Friday put the brakes on their push to speed Pfizer's COVID-19 to children under 5, creating major uncertainty about how soon the shots could become available.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.Kids between the ages of 5 and 11 are now eligible to get the Pfizer-BioNTech COVID-19 vaccine.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.

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