International – ICMRA outlines shape of Phase 3 COVID-19 vaccine trials

A new report provides a roadmap for Phase 3 clinical trials for developers of candidate vaccines for the novel coronavirus SARS-CoV-2, the virus that causes COVID-19. The report indicates which clinical and preclinical data will indicate a vaccine is ready for Phase 3 trials; it also lays out key considerations in designing Phase 3 clinical trials of vaccines for COVID-19.
The report reflects consensus reached at a 22 June 2020 teleconference convened by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) under the auspices of the International Coalition of Medicines Regulatory Authorities. At the workshop, 100 representatives from 28 countries and 20 regulatory authorities worked together to “harmonize regulatory requirements and streamline the development of COVID-19 vaccines.”
Success criteria should be “stringent”
Though regulators reached agreement on many details of when a vaccine should proceed to Phase 3 trials and what those trials should look like, they stopped short of defining exact success criteria. “There was also broad agreement that clinical studies should be designed with stringent success criteria that would allow a convincing demonstration of the efficacy of COVID-19 vaccines. However, whether a vaccine would be considered as acceptable for approval is assessed case-by-case on the basis of all available data on its safety and efficacy,” said EMA in announcing the report.
Some specifics regarding efficacy criteria mentioned in the report include establishing efficacy points estimates that are congruent with the efficacy desired for bot the interim and final efficacy analyses. Though studies should be adequately powered for robust estimation of efficacy, “more conservative stances” on success criteria should help “rule out licensure of weakly effective vaccines that could do more harm than good,” according to the report…