What South Africans need to know about the Wits Covid-19 vaccine trials

Seven need-to-know facts about the Wits University Covid-19 vaccine trials.

The African continent is looking to Wits University in high hopes of their Covid-19 vaccine trials. On 24 June Wits started trails of their vaccine called ChAdOx1 nCoV-19 and is aimed at preventing infection by SARS-CoV-2, the virus that causes Covid-19. According to Wits University, vaccines are among the most powerful tools to mitigate the consequences of life-threatening germs.

They stated that in the absence of a Covid-19 vaccine, there is likely to be ongoing spread of the virus that will continue to cause severe illness and death, especially in those older than 65 years and adults with co-morbidities such as obesity, hypertension and diabetes. Since the announcement of the trials, more conversations on vaccines and how they work have surfaced.

Wits University provided answers to some of the more frequently asked questions about their vaccine, ChAdOx1 nCoV-19:

1. Who manufactured the South African Ox1Cov-19 vaccine? A partnership between Oxford Jenner Institute, the University of Oxford and UK-based AstraZeneca was formed for the global scale-up, manufacture and distribution of the vaccine. The rights to manufacture the vaccine at scale (should it be shown to be effective in protecting against Covid-19) has been transferred to AstraZeneca, who is also partnering with manufacturers such as the Serum Institute in India, to optimise manufacturing of large volumes of the vaccine so that it is widely accessible. Wits University is collaborating with scientists at University of Oxford in evaluating the vaccine in South Africa, although the South African study is largely being led by the local investigators.

2. Has the South African Ox1Cov-19 vaccine been tested on animals? As with most human vaccines, there were several animal species used in the safety and efficacy trials, including ferrets, mice and Rhesus macaques. Rapid, yet thorough, investigations demonstrated good safety and efficacy of a single dose of ChAdOx1 nCoV-19 in the Rhesus macaque model. There are also animal studies underway in Australia and the UK, and the results will be published once those studies are complete.

3. Will children or pregnant women be vaccinated in the Ox1Cov-19 vaccine trial? Women who are pregnant will not be able to enrol in the study. In the event of a woman falling pregnant on the study, further vaccinations will be stopped. The woman will be followed-up during her pregnancy and her infant will be evaluated. The paediatric studies are not enrolling yet, as these are planned to be undertaken only after all of the adults studies are moving along, and have generated sufficient safety data. Additionally, evaluation of the Covid-19 vaccine is currently not a priority for children as data show they are less likely to be infected with SARS-CoV-2 and, even when they are infected, rarely develop severe Covid-19 disease.

4. What is the cost of the South African Ox1Cov-19 vaccine trial to the country and who is carrying the cost? The study in South Africa is being funded locally by the South African Medical Research Council and through a grant from the Bill and Melinda Gates Foundation. The University of Oxford is providing the vaccine at no cost.

5. Will the university or any individual academics benefit from the royalties or profits? Neither the University of the Witwatersrand nor any of the South Africa investigators involved in this study will derive any financial benefit from the development of the vaccine.

6. Is the South African Ox1Cov-19 vaccine trial just a safety test to ensure it can be tried elsewhere? The study being undertaken in South Africa is one of three studies currently underway on this vaccine. These include a study in the UK, which is ongoing and has already enrolled more than 4 000 participants, with an even larger study of 10 000 due to start soon. In addition, another study is underway in Brazil that will enrol approximately 5 000 participants. The South African study aims to enrol 2 000 volunteers, of whom 50 will be people living with HIV.

7. When might we know that the vaccine works? To assess whether the vaccine works to protect from Covid-19, South African and other scientists will compare the number of infections in the control group with the number of infections in the group who received the coronavirus vaccine. If transmission remains high, we may get enough data in a couple of months to see if the vaccine works, but if transmission levels drop, this could take longer.