The Coalition for Epidemic Preparedness Innovations (CEPI) and the International Vaccine Institute (IVI) have partnered for a new clinical research programme to boost access to Covid-19 vaccines in Africa.
CEPI will offer up to $12.7m in funding to the Expanding Access and Delivery of COVID-19 Vaccines in Africa (ECOVA) consortium.
Led by IVI, the consortium will conduct clinical trials of the BBIBP-CorV vaccine developed by Sinopharm. The aim is to expand the vaccine’s use on the continent.
Under an agreement signed last week, the COVAX Facility will supply up to 170 million doses of the vaccine, which is available in more than 50 countries globally.
But no trials of BBIBP-CorV have so far been performed in African people or against the variants of concern circulating in the southern part of the continent.
The ECOVA programme is intended to gather evidence to support the vaccine’s use in Africa and potentially extend its use to HIV patients.
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All data from the programme will be available open-source to aid policymakers and regulatory authorities provide suggestions on the inclusion of BBIBP-CorV in national vaccination initiatives.
ECOVA will involve two trials of the vaccine in Beira and Maputo, Mozambique, which will commence soon. Initial interim data is set to be available by year-end.
Instituto Nacional de Saúde (INS) in Mozambique will lead the trials in alliance with IVI.
CEPI CEO Dr Richard Hatchett said: “The ECOVA project in Mozambique will generate valuable additional data about BBIBP-CorV, with the goal of expanding access to the vaccine for people in Africa.”
One of the ECOVA trials, a Phase III trial, will evaluate the safety and efficacy of BBIBP-CorV against circulating variants of concern in healthy adults in Africa.
In addition, the trial will analyse the safety and immunogenicity of the vaccine in HIV patients, as well as its potential use with seasonal influenza vaccines.
Separately, a Phase II trial will assess the safety and immunogenicity of mixed regimens of BBIBP-CorV and AstraZeneca’s Covid-19 vaccine.
The trials will follow up subjects for two years to obtain critical long-term data.