Dr Glenda Gray, president and CEO of the South African Medical Research Council (MRC), has confirmed that a Johnson & Johnson product called Ad26.COV2-S and a Novavax product called NVX-CoV2373 will be trialled in the country starting next month, reports Spotlight. This development follows the June launch in South Africa of the first COVID-19 vaccine candidate to be tested in Africa. Led by professor in vaccinology at Wits University, Shabir Madhi, the Ox1Cov-19 Vaccine VIDA trial is a collaboration with Oxford University. A total of 2,000 volunteers in South Africa are being screened and given the vaccine or a placebo in this trial.
Among them is Gray, who was injected on Tuesday 11 August, with either a placebo or the potential vaccine against the SARS-CoV-2 virus at a trial site at the Cape Town Lung Institute.
Gray’s mission and those of the many other doctors and nurses who are volunteering for the COVID-19 Oxford trial is to restore confidence in vaccines and is a way of tackling increasing vaccine hesitancy, anti-vaccine sentiment and disinformation about Africans supposedly being targeted and used for “human experimentation”.
Spotlight reports that the three vaccines being evaluated in South Africa are included in the World Health Organisation (WHO) list of the 26 most viable candidate vaccines to go into human clinical trials. There are 139 in pre-clinical evaluation, meaning they are being tested in the lab or in animal models and have not yet progressed to Phase I safety human trials.
The Johnson & Johnson trial will be the first Phase III COVID-19 vaccine trial to be conducted in South Africa starting in September. As with the Oxford trial, the Novavax trial is a Phase IIb trial. In this phase, the efficacy of the vaccine will be tested but is not as powered as a Phase III randomised, double-blind control trial. If successful, the Novavax and Oxford trials will need to move on to larger Phase III trials.
Gray says in Spotlight that a positive spin-off of participating in trials in South Africa is that it will be easier to negotiate for access to a successful COVID-19 vaccine for citizens once it is registered through the manufacturing companies or financing schemes at a global level. It is also important to see how South Africans respond to the vaccine, she says.
Gray is the global co-chair of the Johnson & Johnson Ad26.COV2-S trial and is the national principal investigator together with Professor Linda-Gail Bekker, the COO of the Desmond Tutu Health Foundation (formerly the Desmond Tutu HIV Foundation). Gray says approval from the South African Health Products Regulatory Authority (SAHPRA) and ethics committee approval is in progress.
Madhi is the lead investigator for the Novavax trial, which is being funded by the Bill and Melinda Gates Foundation. When approached for comment, Madhi said an announcement of the Novavax trial is expected this week. A week ago, the Maryland-based company in the US reported that its candidate vaccine NVX-CoV2373 produced high levels of antibodies against the novel coronavirus in an early-stage clinical trial, and that it would start large Phase III trials as soon as late September. The small Phase I study, which started in late May, tested the vaccine in 106 subjects aged 18 to 59 versus a placebo. It looked at the vaccine’s safety and ability to induce an immune response.
Madhi confirmed that the trial to be conducted in South Africa will be a Phase IIb trial – which will be powered to measure efficacy, but not to the extent required for registration (for which a Phase III trial is typically needed).
[link url="https://www.spotlightnsp.co.za/2020/08/11/sa-to-take-part-in-two-more-covid-19-vaccine-trials/"]Full Spotlight report[/link]