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Regulatory Focus™ > News Articles > 2020 > 6 > International regulators iron out COVID vaccine trial harmonization

International regulators iron out COVID vaccine trial harmonization

Posted 24 June 2020 | By Kari Oakes 

International regulators iron out COVID vaccine trial harmonization

As more candidate vaccines for the novel coronavirus are progressing to advanced clinical trials, international regulators are planning for international convergence on the nuts and bolts of what is needed to move to phase 3 trials of COVID-19 vaccines.

On Monday, a group of regulators were convened under the umbrella of the International Council of Medicines Regulatory Authories (ICMRA) for a multinational discussion. In all, 100 regulators from more than 20 countries and the World Health Organization participated, with representation from 28 regulatory authorities at the virtual meeting.

The meeting was co-organized by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA); co-moderaters were Marco Cavaleri, PhD, head of Biological Health Threats and Vaccine Strategy at EMA and Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA.

“Many researchers around the world are currently working on vaccines against COVID-19 but a rapid authorization of COVID-19 vaccines will only be possible if robust and sound scientific evidence on vaccine candidates’ quality, safety and efficacy is generated,” said EMA.  “International convergence of data requirements is intended to encourage and accelerate the development of vaccines as a global public health good.”

Key aspects of phase 3 clinical trials for COVID-19 vaccines should be harmonized in order to expedite and streamline both the development process and authorization by regulators, noted EMA. Moving to phase 3 trials will require acquisition of a body of non-clinical and clinical data whose scope was discussed by regulators.

Once a candidate vaccine is in phase 3 trials, international progress toward rapid authorization will be aided by convergence on such key components as eligibility criteria for diverse participant populations, selection of primary endpoints for vaccine trials, and other methodological considerations, said EMA. The agency said that details of what was discussed and the outcomes that were agreed upon will be forthcoming within the coming days.

Monday’s meeting follows a March 2020 virtual meeting of international regulators, also held under the auspices of ICMRA, that focused on moving to the human clinical trial stage for COVID-19 vaccines. At that first meeting, participants affirmed their commitment to keeping active lines of international information exchange about vaccine development efforts.

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