South Africa Starts Human Trial Of Second COVID-19 Vaccine

South Africa Has Begun A Human Trial Of A Second COVID-19 Vaccine, And It’s Likely At Least One More Will Be Rolled Out Before The End Of The Year.

South Africa Starts Human Trial Of Second COVID-19 Vaccine

“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,” explained Shabir Madhi, the University of Witwatersrand professor of vaccinology who is leading the trial. “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.”

The vaccine, known by the technical name NVX-CoV2373, is produced by the American biotechnology company Novavax.  The trial will evaluate the vaccine candidate’s safety, its ability to provoke an immune response and its efficacy in conferring protection against COVID-19.

The phase 2 trial will enroll about 2,904 randomly selected volunteers between the ages of 18 and 64, according to a statement from the University of Witwatersrand in Johannesburg, whose scientists are leading the study. The phase 1 trial, conducted in Australia, showed that the vaccine candidate was generally well-tolerated and drew robust antibody responses that were numerically superior to those seen in humans who have recovered from COVID-19. Studies conducted in non-humans showed protection against the novel coronavirus infection in nasal passages and lungs.

Madhi is also overseeing the continent’s first human trial of a COVID-19 vaccine, which began in June and is expected to conclude later this year. It’s testing the efficacy of a vaccine that goes by the technical name ChAdOx1 nCoV-19 and was developed by researchers at the University of Oxford in the United Kingdom.

“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 said.

Why is South Africa hosting COVID-19 vaccine trials?

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, Madhi said.

The latest trial is happening in South Africa because Madhi reached out to Novavax, a company he worked with previously, to ascertain its interest, according to the Pasha podcast published by The Conversation Africa.

“The main reason we want to run more than one study on COVID-19 (vaccines) is the legacy of vaccines is less than 10 percent of vaccines that enter human trials actually get licensed,” he explained. “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 been shown to be safe and efficacious.”

A statement from Novavax explained that the company intends to initiate similar phase 2 trials in the United States and Australia which will involve approximately 1,500 volunteers. The South African study is part of a larger clinical program to evaluate the vaccine candidate globally, according to the statement. 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,” Novavax President Stanley Erck said in the statement issued by the University of Witwatersrand.

The Bill & Melinda Gates Foundation awarded Novavax a US$15 million grant for the COVID-19 vaccine trial in South Africa.

Human trial, The pharmaceutical firm Johnson & Johnson is expected to launch a third COVID-19 vaccine trial in South Africa by the end of September, Madhi said, and 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,” he said. “Right now, they have been reaching out to a number of different companies on which of those will be interested in possibly doing multi-country studies on the African continent.”

Time for Africa to develop its own vaccines

Human trial, There is no approved cure or vaccine for COVID-19, though 176 vaccines are under development globally by research institutions, universities, government agencies and pharmaceutical companies, according to the World Health Organization. None are 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 working on any COVID-19 vaccine is by participating in the two South Africa trials.

Madhi expressed concern on the Pasha podcast about Africa’s “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 simply hasn’t been enough investment. Not just by government but also by the private sector in terms of research and development of vaccines on the African continent.”

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

“African leaders are not interested in research and development,” he said. “We have not built the necessary structures. 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.”

Developing vaccines locally is the sure way to give Africans increased confidence in vaccines, Owusu said.

“It is expensive to develop vaccines,” he noted. “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.

This news was originally published at allianceforscience.cornell.edu

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