COVID-19 vaccines: Global regulators debate phase 3 data requirements

Global regulators have held a workshop designed to nail down the data they will require of companies developing vaccines against COVID-19.

Developing a safe and effective vaccine is seen as a vital step to ending the ongoing crisis sparked by the pandemic.

Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international watchdogs discussed COVID-19 vaccine development and the necessary evidence required for regulatory decision-making at a meeting was jointly organised by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

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

The meeting 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 eligibility criteria for inclusion of diverse populations, primary endpoints and other methodological considerations related to the design of phase 3 studies.

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 June workshop brought together 100 participants from more than 20 countries, representing 28 medicines regulatory authorities and the World Health Organization. It was led by Dr Marco Cavaleri, Head of Biological Health Threats and Vaccines Strategy at EMA, and Dr Marion Gruber, Director of Office of Vaccines Research & Review at the US FDA.

With several vaccine candidates moving into phase 2 and 3 studies, hopes are rising in some quarters that a vaccine might receive regulatory approval before the end of 2020. However, seasoned industry experts and public health officials warn that it is unlikely that a vaccine could be approved, manufactured and delivered to hundreds of millions of people until the winter of 2021.