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Pfizer COVID-19 Vaccine Might Not Be Authorized for Young Children Until November

Pfizer’s and BioNTech’s COVID-19 vaccine may not receive FDA authorization for children ages five to 11 until November, as the companies have yet to submit a revised Emergency Use Application (EUA) to the FDA.

The companies sent the agency initial positive data earlier this week from a phase 2/3 study evaluating their COVID-19 shot in children ages five to 11, but they need more time to complete an EUA application covering this group.

Pfizer declined to comment to FDA news on the precise timing of its revised EUA submission to the FDA and said it can’t “speculate on how long the FDA’s review will take.”

September 30, 2021

https://www.fdanews.com/

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