EXCLUSIVE-FDA widens U.S. safety inquiry into AstraZeneca coronavirus vaccine -sources
By Marisa Taylor and Dan Levine
WASHINGTON, Sept 30 (Reuters) – The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.
AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.
The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said.
Effective vaccines are seen as essential to help end
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