I covered the main points on this in an earlier post here: The US FDA has broadened its investigation into AstraZeneca COVID-19 vaccine candidate
Reuters have a report with further detail here:
- AstraZeneca's large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill
- 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.