In reversal, FDA puts brakes on COVID shots for kids under 5 | The Associated Press

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In reversal, FDA puts brakes on COVID shots for kids under 5 | The Associated Press
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COVID-19 vaccinations for children under 5 hit another monthslong delay Friday as US regulators abruptly put the brakes on their efforts to speed review of the shots that Pfizer is testing for youngsters.

The Food and Drug Administration, worried about the omicron variant’s toll on kids, had taken the extraordinary step of urging Pfizer to apply for OK of the extra-low dose vaccine before it’s clear if tots will need two shots or three. The agency’s plan could have allowed vaccinations to begin within weeks.

The nation’s 18 million children under 5 make up the only age group not yet eligible for vaccination. Vaccine experts had been concerned with the sudden race to evaluate Pfizer’s vaccine — and now wonder what parents will make of the back-and-forth. So it was a surprise when a few weeks ago, FDA urged Pfizer and its partner BioNTech to go ahead and apply. Next week, the agency’s independent scientific advisers were set to publicly debate if it was OK to start giving tots two shots before there was proof that a third would give them the extra needed protection — a highly unusual move.

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