FDA widens U.S. safety inquiry into AstraZeneca coronavirus vaccine -sources - (Financial Post via NewsPoints Desk)

  • 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. 

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