Solidarity Trial Vaccines.  An international randomised trial of candidate vaccines against COVID-19

Overview

This large, international, randomized controlled clinical trial is designed to enable an expeditious, agile and concurrent evaluation of the benefits and risks of multiple candidate preventive vaccines against COVID-19 at international sites with sufficient COVID-19 attack rates. The trial is designed to provide sufficient evidence of safety and vaccine efficacy against COVID-19 to support decision-making about global vaccine deployment, which may include licensure and/or WHO pre-qualification.

Goal and objectives of the trial

The goal of the trial is to coordinate prompt, efficient, and reliable evaluation of the many preventive candidate SARS-CoV-2 vaccines under development. The objectives are to assess their safety and efficacy and to identify those that are likely to be appropriate for deployment to influence the course of the pandemic.

Need for the trial

Although some vaccines are now available in parts of the world, it is clear that supply of existing vaccines that have been rigorously evaluated will be inadequate to meet international needs. The detection of variants that may elude some aspects of vaccine-induced immunity makes clinical testing of new vaccines all the more important, to assure that vaccines that are deployed around the world are truly safe and effective.