South Africa has begun a human trial of a second Covid-19 vaccine with an indication at least one more will be rolled out before the end of the year.

The vaccine known by the technical name NVX-CoV2373 is produced by American biotech company Novavax. 

statement from the University of Witwatersrand in Johannesburg which’s scientists are leading the study explained this is a phase two trial of the vaccine and will enroll about 2,904 randomly selected volunteers who are aged between 18 and 64 years.

The trial will evaluate the vaccine candidate’s safety, the ability of a foreign substance to provoke an immune response, and efficacy of the vaccine in protecting against Covid-19.

The statement said Phase 1 of the trials in Australia has shown that the vaccine candidate was generally well-tolerated and drew robust antibody responses, numerically superior to that seen in humans who have recovered from Covid-19.

“The major motivation for Covid-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own,” Shabir Madhi, Professor of Vaccinology at the University of Witwatersrand who is leading the trial explains in the statement.

“This would enable informed decision-making when advocating for the adoption of this or other Covid-19 vaccines in African countries, once they are shown to be safe and effective.

“Participating in the clinical development of these vaccines at the outset will assist in advocating for South Africans to be amongst the first in line to access these life-saving vaccines, once they become available,” Madhi explains.

The statement says studies of the Novavax vaccine in non-humans have shown protection against Covid-19 virus infection in nasal passages and lungs. 

Why more Covid-19 vaccine trials are important in South Africa

This is the second Covid-19 vaccine being tested in South Africa, both of which are led by Madhi. In June, trials begun for a Covid-19 vaccine known technically as ChAdOx1 nCoV-19 which was developed by researchers at the University of Oxford in the UK.

That trial is progressing steadily and is expected to be completed before the end of the year.

When administered to people, the Novavax vaccine and the University of Oxford vaccine-like all Covid-19 vaccine candidates currently under development will protect them from the virus that causes Covid-19.

“The way the study ended up in South Africa is, I reached out to Novavax to find out if they are interested in conducting a study in South Africa. I have worked previously with Novavax,” Madhi explained in the Pasha podcast published by The Conversation Africa.

Madhi says South Africa will be in a better position to protect its population against spread of the virus if the country works on multiple Covid-19 vaccine candidates instead of focusing on just one.

“The main reason we want to run more than one study on Covid-19 (vaccines) is; the legacy of vaccine is; less than 10% of vaccines that enter human trials actually get licensed…

“The other reason why we need to evaluate multiple vaccines is that there is no telling which of the vaccines will protect against Covid-19 in different populations…We probably are going to require four to five vaccines that have shown to be safe and efficacious,” he adds.

statement from Novavax explained it intends to initiate similar phase 2 trials in USA and Australia which will involve approximately 1,500 volunteers.

Novavax says the South African study is part of a larger clinical programme to evaluate the vaccine candidate globally. A third phase of the trials involving approximately 30,000 participants will be launched soon.

“This important phase 2 clinical trial will not only provide additional data on safety and immunogenicity (ability of foreign substances to provoke immune response) of NVX-CoV2373, it also has the potential to provide an early indication of efficacy, as South Africa is experiencing a surge of Covid-19,” Stanley Erck who is President of Novavax said in the statement issued by the University of Witwatersrand.

Novavax has been awarded a US$15 million grant by the Bill and Melinda Gates Foundation for the Covid-19 vaccine trial in South Africa.

A third Covid-19 vaccine trial is expected in South Africa by the end of September by pharmaceutical firm Johnson and Johnson.

Sabhir says more are likely to follow across the continent. “In addition to the third vaccine trial that is in motion, Africa Centres for Disease Control has been aggressive in trying to attract pharmaceutical companies to conduct trials in African countries.

Right now, they have been reaching put to a number of different companies on which of those will be interested in possibly doing multi-country studies on the African continent.

“So, I think over the next few months, hopefully we might get some insight from the African CDC in terms of how successful it’s been to attract more studies on Covid-19 vaccines on the African continent,” Madhi adds.

Time for Africa to invest in development of Covid-19 vaccines locally  

There currently exists no approved cure nor vaccines for the Covid-19 disease. As at the end of August 2020, 176 vaccines are under development all over the world by research institutions, universities, government agencies and pharmaceutical companies according to the World Health Organisation.

None of these vaccines is being developed in Africa, a situation attributed mainly to lack of investment in health infrastructure and research generally over the years.

The closest Africa has gotten to work on any Covid-19 vaccine is the trials ongoing to test their safety and efficacy in South Africa.

Madhi expresses concern about “systematic lack of investment in terms of promoting the type of sciences required to actually design and manufacture vaccines.”

“This is simply a legacy of the past. There haven’t simply been enough investments. Not just by government but also by the private sector in terms of research and development of vaccines on the African continent,” he told the podcast.

Dr. Michael Owusu, a clinical microbiologist at the Kwame Nkrumah University of Science and Technology in Ghana tells Joy News it is about time that the agenda is set right for Africa to develop its own vaccines.

“African leaders are not interested in research and development. And research is the sure way to get a lot of these. We have not built the necessary structures,” he says.  

“To be able to manufacture a vaccine, you need to make huge investments. And this can take the next 10 to 15 years to build that human resource capacity, have the infrastructure, and have the scientists, environment, the machines, the animal models and all that. We need to really plan and put a lot of money in it,” Dr Owusu adds.

The clinical microbiologist says developing vaccines locally is the sure way to give Africans increased confidence in vaccines. “It is expensive to develop vaccines. It’s not that cheap.

But if we are able to do this, Africa will become more confident in what we do… Looking at the way pandemics come and go, investment in the infrastructure, research and development is the way to go for Africa if we want to be ahead in terms of science and manufacture our own things for our people,” Owusu explains.

Source : myjoyonline