South Africa recently launched its third COVID-19 vaccine trial in the country, called the ENSEMBLE study. The clinical trial is conducted by the Desmond Tutu Health Foundation, the South African Medical Research Council, and pharmaceutical company Johnson & Johnson. The Vaccine Advocacy Resource Group (VARG) is a global group of advocates working for accountable, transparent, and community-owned vaccine research. Here, the VARG answers some of the most frequently asked questions about South Africa’s latest COVID-19 vaccine trial.
1. What is the latest vaccine trial?
The ENSEMBLE study aims to see whether an experimental vaccine can prevent people from becoming infected with the new coronavirus or developing serious COVID-19 disease. The vaccine will be tested among 60,000 adults in nine countries, including the United States, Argentina and South Africa. ENSEMBLE is a Phase 3 trial. This means that the vaccine has already gone through the initial phases of research (Phase 1 and Phase 2) taking a first look at safety and dosage. The study is a randomised controlled clinical trial, which means that volunteers will be randomly assigned to either get the experimental vaccine or a placebo, in this case, a simple solution of salt and water.
Because patients in the trial are randomised to either the vaccine or the placebo group, any factors such as patients’ ages, weight, or medical history should be equally divided between both groups. Studies such as these are better able to show cause and effect than other types of research. Randomised controlled clinical trials are often called “the gold standard” in science. The ENSEMBLE study is expected to last about two years.
You can read more about how the study will be conducted in the study design document, also known as the study protocol here.
2. Is the vaccine safe?
The vaccine being used in the ENSEMBLE study has already been given to more than 800 volunteers in a smaller study in Belgium and the United States, which showed it was safe to use.
3. Why should South Africa take part in vaccine trials?
The earliest human trials for new vaccines take place in a small number of people to produce data on safety. Safety data is pretty universal, experts say, meaning that once a vaccine or medicine is proven to be safe in one population, it’s safe for everyone.
But it’s a different story when it comes to showing that vaccines work. Factors such as genetics, living conditions and strains of bacteria or viruses can differ between population groups and can impact how well a vaccine works from one place to the next. The same vaccine may be very effective in one country and somewhat less effective in another depending on factors such as these as well how much of the disease the vaccines are meant to prevent is circulating in communities.
Local health officials need to know how well a vaccine works in a context like theirs, so they know it makes sense to invest in it and how to roll it out. If vaccines aren’t tested in South Africa, we don’t know how well they will work for communities in the country. Historically, a lack of vaccine trial data from Africa has been one of many reasons that some vaccines haven’t reached communities here until well after they are available in much richer countries
4. How is the ENSEMBLE study making sure that a future COVID-19 vaccine will work for those who need it the most?
When it comes to the new coronavirus, older people and people with other health conditions such as diabetes and high blood pressure are most at risk of developing severe COVID-19. The ENSEMBLE study is going to include these groups to try to ensure that any future vaccine would work for those who need it most. Initially, the study will enroll volunteers who are over 18 and under the age of 60 to check once more that the vaccine is safe and that it produces an immune response.
Once scientists and independent monitors have more data to confirm that the vaccine is safe and does indeed show promise in our population, only then will the trial take volunteers that are over the age of 60 or have underlying health issues.
5. How are clinical trials monitored?
Clinical trials in South Africa must receive regulatory approval from the South African Health Products Regulatory Authority (SAHPRA) before they begin. SAHPRA is the government body tasked with overseeing the approval of not only clinical research but also new medicines and medical devices. Studies must meet rigorous safety and ethical requirements to gain SAHPRA approval, including obtaining a medical ethics approval from one of the country’s registered medical ethics review boards, many of which sit within universities. Once trials are approved, there are multiple ways that independent experts and community members monitor vaccine safety. For instance, all clinical trials must record what is called adverse events, which can be anything from rashes to more serious illnesses that could be potential side effects of experimental medicines or vaccines.
All adverse events that happen within South African clinical trials are reported to SAHPRA. Additionally, independent Data and Safety Monitoring Boards (DSMBs) also review safety data from trials regularly and can recommend that clinical trials are stopped early if data shows that a vaccine is ineffective or unsafe. Lastly, most major trials in South Africa have community advisory boards (CABS). CABs are composed of representatives and leaders from communities impacted by trials and work to ensure that communities’ interests are safeguarded during the clinical trial process.
6. Why is it important that communities in South Africa are involved in clinical trials?
International guidelines from bodies such as the World Health Organization and UNAIDS recommend that all clinical trials meaningfully engage with local communities. “Communities” can mean either a group of people who live in the same area or people who share an identity, interests or social networks. Communities must be engaged in how research studies are designed, conducted and concluded. People have a right to know about clinical research being conducted in their area, or that could affect them. Importantly, community representation within clinical trials, including but not limited to CABs, can help safeguard communities’ interests.
And when research studies meaningfully involve communities, most scientists agree that studies are better able to adapt to local realities and produce scientific advances such as medicines or vaccines that are designed to work for communities in real life. South Africa’s latest clinical trial guidelines say that research ethics committees, which must approve trials before they start, should ask all trials to provide a plan for how community representatives will be consulted as part of trials and how trial results will be fed back to communities. Clinical trials say the guidelines, should ideally include CABs.
The United States’ National Institutes of Health, which funds some studies in South Africa, has required the use of CABS in work it funds since the late 1980s. The VARG works to support the meaningful involvement of communities within clinical research, and this kind of engagement shouldn’t begin when trials start. Communities should be involved in the development, implementation and post-study follow-up of clinical trials.
7. What happens if the vaccine being tested as part of ENSEMBLE works?
If the vaccine is successful, Johnson & Johnson has publicly committed to seeking no profit from the jab in the short-term. The VARG joins others in civil society who echo the need for a future COVID-19 vaccine to be safe, effective and affordable to those in the Global South.
Podcast with Ensemble co-chair and Desmond Tutu Health Foundation CEO Linda-Gail Bekker
Tian Johnson, Founder & Strategist, The African Alliance,
Maaza Seyoum, Partnerships & Communications Lead, The African Alliance,
Governments and international partners must unite around a global guarantee which ensures that, when a safe and effective vaccine is developed, it is produced rapidly at scale and made available for all people, in all countries, free of charge. The same applies to all treatments, diagnostics, and other technologies for COVID-19.
We support the call for a Peoples Vaccine!