Regulatory Authorities have Published a Report on COVID Vaccine Development

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development convened under the umbrella of the International Coalition of Medicines Regulatory Authorities.

According to a July 9, 2020 press release, the aligned positions incorporate two key topics, which are highlighted in the report. The topics are the need for data from laboratory, animal, and human studies so that Phase III clinical trials of a COVID-19 vaccine can be initiated, and considerations of study design for the Phase III clinical trials.

Emphasis was placed upon the requirement for Phase III clinical trials by the meeting participants, as these trials enroll thousands of people and should include those with underlying medical conditions so that relevant data can be generated. Additionally, there was agreement that the clinical studies should be designed with stringent success criteria to ensure there is convincing demonstration of efficacy.

More details are available on the European Medicines Agency’s website.

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