According to three sources familiar with the matter, the FDA has broadened its probe of a serious adverse event that occurred recently in AstraZeneca's COVID-19 vaccine study, as reported in the Financial Post.
The agency will look at data from earlier trials of similar vaccines developed by the same scientists, the people said.
Two of them indicated that the requested data was expected to arrive this week, after which the FDA would need time to analyze it.
AstraZeneca's late-stage US trial of the AZD1222 vaccine candidate has remained on hold since September 6, after a study participant in the UK fell ill with what was thought to be transverse myelitis.
The Trump administration has pledged $1.2 billion to support development of the AstraZeneca vaccine and secure 300 million doses for the US.
To read more NewsPoints articles, click here.