The University of WITS has launched a second COVID-19 vaccine trial in South Africa by US-based biotech company Novavax, the clinical trial starts on the heels of another vaccine trial which started in June and is led by Professor of Vaccinology Shabir Madhi.
Current studies show that the Novavax vaccine administered on non-human primates has shown protection against SARS-Cov-2 infection in the nasal passages and lung disease.
Madhi says the trial will help the country generate evidence on how well these vaccines work in an African context.
Participants are currently being screened for the second COVID-19 vaccine trial that’s aimed at evaluating a particle in the vaccine that protects adults between 18 and 64 years old against the coronavirus.
The nano-particle S-protein is produced by Novavax.
Madhi says, “We started our first vaccine study about 6 weeks ago and we have had an overwhelming response of people coming forward, volunteering and wanting to be part of the study. So fortunately we don’t have any shortage of volunteers.”
Two thousand nine hundred volunteers will participate in the trial and Madhi says they will be tracked closely to find out if the vaccine protects against COVID-19 or not.
The video below is on Wits University leading the Novavax clinical trials – phase 2:
“In the first study, we are looking at enrolling about 2000 participants. The current study will be closer to 3000 participants. Neither the participants nor the investigators know who is receiving what. What we then do is follow up those individuals very intensively. The first reason is to see whether the individual is experiencing any side-effects that might be related to the vaccine. The second reason is to see if they develop COVID-19,” says Madhi.
They will also be checking how the body’s immune system responds to the vaccine.
“We need to see the number of cases or what percentage of people receiving the vaccine develop COVID-19 and compare that to the number of people that received the placebo that developed COVID-19.”
“What we expect or hope to happen is that the group that received the vaccine would have a lower rate of COVID-19 compared to the people that received the placebo. What we also do is compare the groups in terms of any other medical conditions that might arise. And then we compare the two groups to make sure that there isn’t an increase in the medical condition in the group that received the vaccine. Because that could mean that there are safety issues we need to consider,” added Madhi.
He says a major motivation for conducting the latest COVID-19 vaccine trial in South Africa, is to generate evidence on how well these vaccines work in an African context.
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SA participation in international trials
The vaccine is already being evaluated in a large clinical trial in the United Kingdom where more than 4 000 participants have already been enrolled.
Similar studies are about to start in Brazil, with an even larger study of the same vaccine of up to 30 000 participants is planned in the USA.
“It is essential that vaccine studies are performed in southern hemisphere countries, including in the African region, concurrently with studies in northern hemisphere countries,” says Professor Helen Rees, Chair of SAHPRA and Executive Director of the Wits Reproductive Health and HIV Institute.
“This allows evaluation of the efficacy and safety of candidate vaccines to be assessed in a global context, failing which the introduction of many life-saving vaccines into public immunization programmes for low-middle income countries frequently lags behind those in high-income countries.”
In the video below, watch the launch of the vaccine trial:
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