African Union aims to scale up COVID-19 vaccine clinical trials

NAIROBI — Currently there is only one clinical trial of a COVID-19 vaccine candidate in sub-Saharan Africa, taking place in South Africa. But the African Union and World Health Organization, among others, are hoping that the number of clinical trials will increase across the continent to ensure that any successful vaccines that come to market will actually work for African populations and that they will be accessible to people across the continent.

The African Union launched a new consortium on Thursday aimed at bringing together global vaccine developers, funders, and African organizations that conduct clinical trials. It aims to ensure that more than 10 late-stage trials are conducted in Africa for the development of a COVID-19 vaccine so that there is enough data gathered on the safety and efficacy of vaccine candidates among African populations.

Low levels of participation

A vaccine is seen as one of the greatest chances that countries have to return to normalcy following widespread disruptions of societies in efforts to contain the novel coronavirus.

“We can expect this virus to continue circulating until a vaccine is made available to people in the world and to people in Africa,” said Dr. Matshidiso Moeti, WHO regional director for Africa, during a press conference.

According to the African Academy of Sciences, only 2% of clinical trials globally, for all types of vaccines, take place in African nations.

This is problematic because people of different ethnic backgrounds could react to a vaccine differently, Moeti said. Having localized trials ensures that vaccines are effective and safe.

“It's important that this product has the opportunity to be tried out in African people. Then we can get the most relevant information about how it behaves, its efficacy, and how people in Africa react to this product. That is why it's extremely important to carry out clinical trials,” she said.  

It can also help to expand access to future vaccines for people on the continent. One of the ethical principles of vaccine trials is that those who participate should have access to the vaccine when it becomes available, Moeti said.

Sub-Saharan Africa’s first COVID-19 clinical trial

The new consortium aims to set up partnerships with vaccine developers, identify countries that should host these trials, set up independent review boards to oversee the trials, increase the awareness of the importance of local trials, provide guidance on interpreting the trial results, and engage with global donors to support the trials.

Consortium members include WHO, The Africa Academy of Sciences’ Clinical Trials Community, Institut Pasteur, African Vaccine Regulatory Forum, AUDA-NEPAD, and the African Medicines Agency, when it becomes established, among others.

Currently, there are nearly 150 COVID-19 vaccine candidates and 19 of those are in clinical trials, according to WHO.  

The South Africa clinical trial is hosted by the University of Witwatersrand in Johannesburg and is testing a vaccine developed by the Oxford Jenner Institute in the United Kingdom. The vaccine is also undergoing trials in the UK and Brazil.

Enrollment for the clinical trial began two weeks ago, according to Shabir Madhi, principal investigator of the trial. The plan is to enroll 2,000 participants and follow them for about a year. But researchers anticipate that results over whether the vaccine works could come sooner — by either November or December — given the high rate of transmission of COVID-19 in South Africa, increasing the likelihood of exposure for the participants.

Participants are between the age of 18 and 65 years, without any underlying serious medical condition. And the trials are mainly investigating the reactions to the vaccine of people who are not HIV positive, Madhi said.

Researchers in South Africa approached the University of Oxford to be part of the trial, he said. The funding for the trial comes from the South African Medical Research Council and the Bill & Melinda Gates Foundation.

Egypt is the only other country on the continent conducting clinical trials for a COVID-19 vaccine.

Vaccine trial aversion

There has been controversy in recent months framed around African populations being used as “guinea pigs” in COVID-19 vaccine trials, following the comments of two French doctors.

It is important to emphasize to people across Africa that clinical trials on the continent in recent years have been conducted with good ethical and regulatory processes, with capacity developed from years of conducting vaccine trials for diseases such as HIV and Ebola, said Pontiano Kaleebu, director of the MRC/UVRI and LSHTM Uganda Research Unit.

“The systems are in place now in African countries. Those cautions are being taken. The regulatory bodies are being increasingly well developed, and these principles are being respected in African countries,” Moeti said.

During the Ebola outbreak in the Democratic Republic of the Congo in 2018 in Equateur Province, people were initially reluctant to participate in vaccine trials, she said. But educational efforts surrounding the benefits of participation and the high standards that were used in the trial have encouraged greater participation during the recent Ebola outbreak in June in the same province.

“A great deal of work had to be done to persuade the population to be vaccinated. Now, our experience is proving to be quite different — that there was a very keen interest in the population to be vaccinated in the outbreak that just started some weeks ago,” Moeti said.