Global regulators discuss requirements for phase 3 trials of Covid-19 vaccines

Covid-19 vaccine trial harmonization

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phase 3 trials
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Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed Covid-19 vaccine development and the necessary evidence for regulatory decision-making at the second regulatory workshop Covid-19 vaccines. The meeting was jointly organized 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. International convergence of data requirements is intended to encourage and accelerate the development of vaccines as a global public health good.

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 the authorization of vaccines against Covid-19.

The meeting built on the experience and knowledge gained from the first workshop on Covid-19 vaccine development was held in March 2020. It 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.

The workshop was moderated by Dr Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at EMA, and Dr Marion Gruber, director of Office of Vaccines Research and Review at the US FDA. 

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