The University of the Witwatersrand (Wits) has launched its second COVID-19 vaccine trial, testing an experimental shot made by US biotech company Novavax, reports Business Day. The phase 2b trial of the shot called NVX-CoV2373 will enrol about 2,900 adult volunteers, including 240 who are HIV positive. It will evaluate the shot’s safety and ability to stimulate the body’s immune system to protect against future infection with SARS-CoV-2, the virus that causes COVID-19.
Participating in the trial means South Africa will be among the countries prioritised for access to the Novavax vaccine, should it prove safe and effective, said Shabir Madhi, the trial’s principal investigator in South Africa and an executive director of the SA Medical Research Council vaccines and infectious diseases analytics research unit at Wits. It was also important to conduct early-stage research in African populations to ensure the product worked in a local setting, he said.
According to Business Day, the NVX-CoV2373 vaccine combines several coronavirus spike proteins in a nanoparticle, mixed with an adjuvant to boost its effect. This protein-based approach has been used successfully for several other vaccines, including those offering protection against hepatitis B and shingles.
Novavax said it expects NVX-CoV2373 will ultimately be supplied to South Africa through its collaboration with India’s Serum Institute, the world’s largest vaccine manufacturer. Novavax has signed a non-exclusive licensing agreement with the Serum Institute to manufacture up to 1bn doses of NVX-CoV2373 for low- and middle-income countries.
The report says the Bill & Melinda Gates Foundation has awarded Novavax a $15m (about R261m) grant towards funding the South Africa trial and the Coalition for Epidemic Preparedness Innovations has funded the manufacturing of the doses of NVX-CoV2373 required for the phase 2 trial in South Africa.
“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,” Novavax research chief Gregory Glenn said in an IoL report.
Novavax intends to begin Phase 2 of the small clinical trial in the US and Australia in the near future and said it would include about 1,500 candidates. It also aims to begin Phase III as soon as late September.
The US government in July awarded Novavax valued over R27bn to cover testing its potential coronavirus vaccine in the US and manufacturing with the aim of delivering a 100m doses by January.
Participating in the trial means South Africa will be among the countries prioritised for access to the Novavax vaccine, should it prove safe and effective, said Madhi in a Business Day report. It was also important to conduct early-stage research in African populations to ensure the product worked in a local setting, he said.
Madhi said it was important to conduct the NVX-CoV2373 trial in an environment where there was a significant amount of COVID-19 circulating in the population, as about 50 people needed to be infected with the disease before the shot could be assessed.
South Africa is banking on its research expertise to gain a place at the international negotiating table for coronavirus vaccines. Business Day reports that unlike the US and UK, which have secured early access to millions of doses of experimental COVID-19 vaccines, South Africa lacks the financial muscle to pre-purchase stocks. Worse still, it has no capacity to make its own.
While South Africa’s participation in vaccine trials is important from a scientific perspective, as it provides vital information on the suitability of the shots for local populations, the international scramble for advance access to promising products has added fresh impetus to South Africa’s involvement in clinical trials, Medical Research Council president Glenda Gray is quoted in the report as saying.
“It puts us in a very strong position from a regulatory perspective, as the regulator will have established a relationship with the company, inspected their manufacturing facilities, and been involved in auditing the trial sites. And if you have contributed to the dossier that allows licensure at a global level, it puts you in a position to develop a relationship with the pharmaceutical company to negotiate access,” she says.
Those international connections also help navigate global financing mechanisms and provide vital access to vaccine manufacturers, of which there are only a handful.
South Africa is pushing hard at an international level for equitable access to COVID-19 vaccines, says Helen Rees, co-director of the Wits African Local Initiative for Vaccinology Expertise (Alive) and an advisory board member of the Coalition for Epidemic Preparedness Innovation (CEPI), but there are no guarantees.
“One lesson we learnt from the flu pandemic of 2009 was that even though a vaccine was developed, virtually all the supplies were rapidly bought by rich countries and South Africa got the vaccine months after it (the pandemic) had ebbed. We cannot continue to have this inequitable global situation where some countries will immunise entire populations and other regions are not going to get vaccines at all,” she says in the Business Day report.
South Africa’s government has expressed interest in participating in the international Covax financing initiative for COVID-19 vaccines, which aims to accelerate the development of promising technologies and fairly distribute them around the world.
Covax is jointly led by the World Health Organisation (WHO), the Global Access to Vaccines Initiative (Gavi) and the CEPI.
“We have indicated our willingness to participate but no agreements have been signed yet,” health minister Zweli Mkhize’s spokesperson, Lwazi Manzi, said in a Business Day report.
The WHO has set an 31 August deadline for finalising the terms of Covax, which plans to invest in about a dozen different experimental vaccines and ensure swift, equitable access once they are proved safe and effective. Pooling funding to support the development of multiple vaccine candidates will help rich countries spread their bets, while ensuring poorer countries receive a share of the shots once they are licensed.
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