AstraZeneca struggles with data needed for COVID-19 vaccine’s approval

Wall Street Journal

29 April 2021 - Company is assembling data for FDA review, hoping for another stamp of regulatory backing in global rollout of its shot.

AstraZeneca executives have struggled to pull together the full data necessary to apply for U.S. approval of its COVID-19 shot, according to people familiar with the matter, further delaying its efforts to secure the FDA’s go-ahead.

The company said last month that it would apply for what is known as emergency use authorisation for its vaccine by mid-April. It has recently told U.S. officials it might need until mid May to finish its application for an FDA review, according to one of these people.

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Michael Wonder

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Michael Wonder

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US , Regulation , Vaccine , Data , COVID-19