Having already undergone Phase I/II of clinical trials that began in April, Oxford’s experimental vaccine is set to be trialled in Brazil and South Africa. Phase III of the trial requires a larger population of at least ten thousand volunteers. The aim of Phase III is to assess and met safety expectations of a marketable vaccine.
Professor Adrian Hill, director of the Jenner Institute, explained that due to the decrease in transmission in the UK, UK-based trials threatened to return “no result”. He says: “We are in the bizarre position of wanting COVID to stay, at least for a little while. But cases are declining.” The decision to expand the trial was not a surprising or unexpected one. Professor Hill had addressed this as a possible pitfall when it came to carrying out the clinical trial at Phase III, in a talk hosted by the Oxford Personalised Medicine Society earlier this term.
Last week, the University announced that the Brazilian Health Regulatory Agency approved the clinical trial, which is already on its way. The unprecedented transmission and spread of COVID-19 in the Brazilian population made the expansion of the trial to Brazil a logical choice. About five thousand volunteers, mainly front-line health workers, are expected to be vaccinated in Sao Paulo, Rio de Janeiro, and in North Brazil. The Federal University of Sao Paulo (UNIFESP) is collaborating with the University of Oxford to coordinate the trial which is being sponsored by Brazilian entrepreneurs. The agreement between the universities and investors includes a commitment to make the vaccine available on a not-for-profit basis.
In South Africa, the University of the Witwatersrand, Johannesburg (Wits) is coming together with the University of Oxford to complete another aspect of the trial. South Africa has seen a rise of more than eighty thousand cases since the President declared a national lockdown. One of the worst-hit countries in the African continent, South Africa contributes to approximately 30% of all COVID-19 cases seen on the African continent. Professor Shabir Madhi, who is leading the trial at Wits University and is the Director of the South Africa Medical Research Council (SAMRC) Vaccines and Infectious Diseases Analytics Research Unit (VIDA) believes that South Africa is still about eight weeks away from its peak.
Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial says of the collaboration: “The global coronavirus pandemic still presents an unprecedented threat to human health worldwide, but equally unprecedented is the impressive way researchers and scientists around the world have been able to collaborate on the clinical development work to combat this threat.”
While implementing an international clinical trial can result in providing efficient and more generalised information for scientific communities, a number of challenges can be expected. Concerns have been raised over the regulatory burden, personnel training and reduced data collection variability. Most of these concerns have already been addressed by the trial researchers.
The Oxford team has already partnered with manufacturers in several countries to scale up vaccine production and if the trial proves successful, up to two billion doses could be available by early next year.
Artwork by Arpita Chatterjee