International regulators align positions on phase 3 COVID-19 vaccine trials

EMA

9 July 2020 - Medicines regulatory authorities from around the world have published a report today highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities.

The report describes the regulatory positions agreed by the meeting participants on two key topics:

  • Data needed from laboratory, animal and human studies to allow initiation of phase 3 clinical trials for a COVID-19 vaccine; and
  • Considerations for study design for phase 3 clinical trials.

Read EMA press release

Michael Wonder

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Michael Wonder