Regulators Discuss Data Requirements for Phase 3 Trials of COVID-19 Vaccines

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.

Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed COVID-19 vaccine development and the necessary evidence required for regulatory decision-making at the second regulatory workshop on COVID-19 vaccines. The meeting was jointly organised by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on 22 June 2020.

“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.”

Source: AIDS Info

During the workshop, global regulators focused on requirements for non-clinical and clinical data from early phase studies that are needed before proceeding with advanced (phase 3) clinical trials with COVID-19 vaccine candidates in humans. They exchanged views on key aspects, such as eligibility criteria for inclusion of diverse populations, primary endpoints and other methodological considerations related to the design of phase 3 clinical trials.

Meeting participants agreed that regulatory convergence, to the extent possible, on certain key aspects of phase 3 clinical trial designs will help developers to generate robust evidence on the quality, safety and efficacy of potential COVID-19 vaccines that meets the needs of regulators around the globe. This is critical for expediting and streamlining global development and authorisation of vaccines against COVID-19.

The meeting built on the experience and knowledge gained from the first workshop on COVID-19 vaccine development held in March 2020, which underlined the urgency of conducting clinical trials with COVID-19 vaccine candidates in humans and international regulators’ commitment to exchange information about the global efforts towards developing vaccines against COVID-19. The second workshop brought together 100 participants from more than 20 countries, representing 28 medicines regulatory authorities and the World Health Organization.

Conclusively, 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.

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