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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.
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The agency will look at data from earlier trials of similar vaccines developed by the same scientists, the people said.
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Two of them indicated that the requested data was expected to arrive this week, after which the FDA would need time to analyze it.
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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.
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The Trump administration has pledged $1.2 billion to support development of the AstraZeneca vaccine and secure 300 million doses for the US.
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