The World Health Organization (WHO) has announced the launch of an international, randomized clinical trial to rapidly evaluate the efficacy and safety of promising new candidate COVID-19 vaccines.
The Solidarity Trial Vaccines (STV) will start in Mali, the Philippines and Colombia and will evaluate vaccine candidates from Medigen (MVC) and from Inovio. Two more promising candidates will be included in the trial shortly afterwards.
The two initial vaccines have been selected by an independent Vaccine Prioritization working group mandated to advise WHO. From all landscaped vaccines in clinical development,[1] the working group reviews the science and evidence to prioritize the most promising candidates for Phase III clinical trial evaluation.
Vaccines that enter the Solidarity Trial Vaccines (STV) are selected based their effectiveness and safety, whether they can be stored and transported easily, how quickly they can be produced for global distribution, and how easily they can be administered.
Global inequity in the distribution of vaccines is fuelling the pandemic. Many countries do not have access to existing COVID-19 vaccines or do not have enough doses to protect their populations.
"Finding more effective and safe vaccines for COVID-19 remains a critical need, and WHO is proud to lead this global effort. We need more vaccines for COVID-19 that are affordable and available to all - so everyone, everywhere across the world can get protected. The Solidarity Trial Vaccines could help us achieve this goal sooner. I would like to thank the participating governments, pharmaceutical companies, clinicians and patients, who have come together to do this in true global solidarity."
The Solidarity Trial for Vaccines (STV) will accelerate the evaluation of multiple promising candidate COVID-19 vaccines, contributing to a larger portfolio of vaccines critically needed to be able to protect people around the world from COVID-19.
In addition, the trial has the potential to uncover second-generation vaccines with greater efficacy, greater protection against variants of concern, offering longer duration of protection, and/or innovations in storage or routes of administration.
As sponsor, WHO is coordinating and overseeing the trial with national Ministries of Health. Independent experts will ensure the trial has the highest possible scientific and ethical standards. A principal investigator in each country will lead a local team that will deliver the study. National teams are already working closely with scientists, public health professionals, community leaders and local communities in planning the delivery of the trial.
The trial will be implemented in over 40 trial sites spread across the three countries although expansion to more countries and sites is expected.
"Selection of sites is based on epidemiological analyses of those with high rates of disease incidence. Some sites will use mobile pop-up sites as well as hospitals and community centres so that the trial can reach more isolated communities. Enrolments into the trial are projected to be around 200 participants per trial site per week"
The STV has the ambition to evaluate as many vaccines as are recommended by the Vaccine Prioritization working group of WHO and for which manufacturers complete the regulatory requirements to donate their vaccine to WHO for the purposes of the trial. The testing of multiple COVID-19 vaccines with standardized methodology will further facilitate regulatory and deployment decisions, including through the COVAX facility.
“The design of the Solidarity Trial Vaccines allows us to assess multiple vaccines at the same time using a single protocol, recruiting thousands of patients to generate robust estimates on the safety and efficacy of vaccines. It also allows vaccines to be added and ineffective ones dropped throughout the course of the trial. ” said Dr Phil Krause from the U.S. Food and Drug Administration (FDA).
Through the Solidarity Trial Vaccines (STV), over 200 researchers in low and lower-middle income countries are contributing to the identification of safe new and effective COVID-19 vaccines.