FDA postpones review of Pfizer data on vaccine for kids under 5

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FDA postpones review of Pfizer data on vaccine for kids under 5
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FDA postpones its review of Pfizer’s COVID-19 vaccine for kids under 5.

Dr. Alok Patel discusses states dropping their mask mandates, including New York, which dropped its indoor mask mandate for businesses.The Food and Drug Administration on Friday postponed its review of Pfizer’s COVID-19 vaccine for kids under 5.

Pfizer applied for an emergency use authorization for its vaccine for kids ages 6 months to 4 years nearly two weeks ago. Studies on a three-shot regimen continue, which Pfizer ultimately expects will be the most effective dosage for the youngest age group.Submitting the data on a rolling basis was intended to get young children started on their vaccinations sooner in the face of the omicron variant and any potential new variants that arise.

“The data that we saw made us realize that we needed to see data from a third dose ... to make the determination that we could proceed with doing an authorization,” Marks said. He went on, “We will do our part obviously, to move as fast as we can when we have the data, but for now we'll have to ask parents to help to continue to do what they've been doing.”

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