WASHINGTON (AP) — Federal health regulators on Friday delayed next week’s public meeting to review Pfizer’s COVID-19 vaccine for children under 5, saying they want to see more data.
The surprise announcement by the Food and Drug Administration raises questions about how soon youngsters could get the shots. The FDA’s outside experts were set to evaluate the first data on COVID-19 vaccinations in toddlers and babies.
The FDA said Pfizer has new data available from its ongoing vaccine study — and the agency needs more time to evaluate it.
The expert panel had been scheduled to meet Tuesday to determine if children under 5 should start getting extra-low doses of Pfizer’s vaccine before it’s clear if they’ll need two shots or three.
The nation’s 18 million children under 5 are the only age group not yet eligible for vaccination. The FDA had pushed Pfizer and its partner BioNTech to apply for authorization of its extra-low doses for tots before final study data was in, as the hugely contagious omicron variant took a toll on children.