Tag Archive for: Vaccine

Andrew Stegmann
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South Africa May Be First in Region to Produce COVID-19 Vaccine

South Africa may sign a deal to help produce a Covid-19 vaccine, potentially boosting access to immunisation on a continent with limited manufacturing capacity.

The Coalition for Epidemic Preparedness Innovations, a global organisation funding vaccine development, is considering the Cape Town-based Biovac Institute as a fill-finish site, according to Helen Rees, the chair of the organisation’s Scientific Advisory Board. The state vaccine company is one of few in the country that has the capacity to package doses into sterile dispensers if clinical trials are successful.

“What we are looking at is partnerships,” Morena Makhoana, Biovac’s chief executive officer, said in response to questions. “Once that is signed, we will be able to make an announcement.”

A manufacturing agreement will “put Africa on a similar path to other continents, much like the clinical trials are doing,” he said.

South Africa is the only country in Africa that hosts several clinical studies. It has 2,000 people in the AstraZeneca Plc and University of Oxford vaccine trial, while Novavax Inc. announced earlier this month it’s starting a Phase 2b clinical trial. One-fifth of the 60,000 volunteers expected to enroll worldwide in Johnson & Johnson’s Covid-19 vaccine trial will be in South Africa, said Glenda Gray, the chief executive officer of the South African Medical Research Council.

“Covid-19 has really thrown into focus that we have very limited capacity for vaccine manufacturing across the African continent, even in countries like South Africa,” said Rees. “But there’s tremendous interest and we need to have more countries being able to manufacture vaccines.”

 

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Andrew Stegmann
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Novavax Starts COVID-19 Vaccine Trial in South Africa

American vaccine development company Novavax says it has begun a Phase 2b clinical trial in South Africa to evaluate the efficacy of a Covid-19 vaccine candidate.

Dr Shabir Madhi, professor of Vaccinology at Wits University, will lead the clinical trial which is supported in part by a $15 million grant from the Bill & Melinda Gates Foundation, the company said in a statement on Monday (17 August).

“Because South Africa is experiencing a winter surge of Covid-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for NVX-CoV2373,” said Gregory M. Glenn, president of Research and Development at Novavax.

“We appreciate the continued support of the Bill & Melinda Gates Foundation and CEPI, and our strong ongoing collaboration with Wits University, all of whom are united with us in our commitment to produce and deliver a safe, effective vaccine across the globe.”

Novavax said that the trial will consist of two cohorts.  The first cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults.

The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults. This allows for evaluation of the vaccine across a diverse, representative study population, it said.

Novavax expects that, if approved in South Africa, its Covid-19 vaccine will ultimately be supplied to in the country through a recently announced collaboration with the Serum Institute of India.

“The major motivation for the 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,” said Madhi.

“I am pleased to work with Novavax as the principal investigator in this clinical trial, following Novavax’ Covid-19 vaccine’s positive Phase 1 data, which provides strong rationale for moving development forward in a larger subset of adults.”

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Sources: [1], [2]. Image sources: [1], [2].

Andrew Stegmann
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Wits University Begins COVID-19 Vaccine Trial

The trial subjects will come from hotspots where the risk of the coronavirus was the highest.

Two thousand South African volunteers are set to be given the Wits and Oxford Universities vaccine for COVID-19 over the next two months. And by the end of the year, scientists will know if it works.

Wits University is expected to launch the clinical trials on Wednesday while 7,000 more people in the UK and 10,000 in the US would also take part in the trial.

Of the 2,000 participants, 1,950 are HIV negative and 50 people are living with HIV and all are between 18 to 65.
Professor of Vaccinology at Wits University Shabir Madhi is leading the South African Ox1Cov-19 Vaccine VIDA-Trial.

“We are trying to see whether there is at least 60% protection against COVID-19, it might be higher or lower. If it is lower, our study would not have the power to conclusively say whether the vaccine works or not,” Madhi said.

The trial subjects will come from hotspots where the risk of the coronavirus was the highest.

“As the world rallies to find health solutions, a South African endeavour for the development of an effective COVID-19 vaccine is testament to our commitment of supporting healthcare innovation to save lives,” said Professor Glenda Gray.

The study will cost $150 million and is funded by the South African Medical Research Council (SAMRC) and the Bill Gates Foundation.

Watch the announcement of the vaccine trial below.

For information as to how Relocation Africa can help you with your Mobility, Immigration, Research, Remuneration, and Expat Tax needs, email info@relocationafrica.com, or call us on +27 21 763 4240.

Sources: [1], [2]. Image sources: [1], [2].