AstraZeneca said Friday that a Phase I/II study of its COVID-19 vaccine candidate AZD1222 has resumed in Japan after discussion with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). All global trials of the vaccine had been paused last month when a UK participant experienced a serious adverse event, although studies have since been cleared to resume in the UK, Brazil, South Africa and India.
Meanwhile, AstraZeneca indicated that it continues to work with the FDA to facilitate a review of the information needed to make a decision regarding resumption of the US trial. Sources recently suggested that the FDA has broadened its probe of the serious adverse event, with the agency set to look at data from earlier trials of similar vaccines developed by the same scientists.
Earlier this week, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) initiated a rolling review of AZD1222, which AstraZeneca is developing with the University of Oxford.
For related analysis, read KOL Views Results: Leading expert encouraged by recent COVID-19 updates but stresses need for controlled data.
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