In Reversal, FDA Puts Brakes On COVID Shots For Kids Under 5

The FDA is reviewing data for Pfizer's COVID-19 vaccine for children under five. Initially, the FDA asked Pfizer to apply for approval before completing its study due to the Omicron variant's impact. However, Pfizer and BioNTech decided to wait for more data on a third dose's efficacy, delaying the process. The FDA postponed a meeting to review trial data, affecting the anticipated vaccine rollout by Presidents Day. The CDC had planned to distribute 10 million doses, with some orders already placed. Approval would relieve families, and the CDC is coordinating with healthcare providers to ensure vaccine availability. Pfizer aims to provide more protection with a three-dose regimen.

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