The FDA has broadened its investigation of a serious illness in AstraZeneca COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with details told Reuters exclusively
WASHINGTON - 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.
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. Regulators in the UK, Brazil, India and South Africa have allowed AstraZeneca to resume its clinical trials there.
While other vaccine developers have used human adenoviruses for such vaccines, the Oxford researchers chose an adenovirus found in chimpanzees. They felt this would reduce the likelihood that an individual’s immune system would attack the vector virus due to prior exposure rather than the intended target.
The type of review being conducted by the FDA is generally intended to scrutinize raw data for other side effects, the sources said.
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