The Coalition for Epidemic Preparedness Innovations (CEPI) and the International Vaccine Institute (IVI) today announced a new programme of clinical research which aims to expand access to COVID-19 vaccines in Africa. CEPI will provide funding of up to $12.7m to the Expanding Access and Delivery of COVID-19 Vaccines in Africa (ECOVA) consortium led by IVI to carry out clinical trials of Sinopharm's BBIBP-CorV vaccine which will support the expanded use of the vaccine on the African continent.
Up to 170 million doses of BBIBP-CorV will be distributed by the COVAX Facility under an agreement announced on 12 July 2021, and the vaccine is already being deployed in over 50 countries around the world. However there have been no clinical trials of BBIBP-CorV in African populations or against the variants of concern circulating in southern Africa. The ECOVA research programme aims to generate crucial data to inform the use of the vaccine in Africa, and potentially expand use of the vaccine to HIV-infected individuals. All results generated by ECOVA will be made available open source to inform policy makers and regulatory authorities' recommendations on the use of BBIBP-CorV in national immunization programmes.
The ECOVA consortium is led by IVI, working in partnership with Mozambique's Instituto Nacional de Saúde (INS), the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), the University of Heidelberg, Germany (UH), Harvard University, USA, and the University of Antananarivo in Madagascar (UA).
Clinical trials in Mozambique
ECOVA will conduct two clinical trials in Beira and Maputo, Mozambique, which will be led by INS in collaboration with IVI. The trials will begin shortly, with the first interim results expected before the end of 2021. Participants in both trials will be followed up for two years to gather important long-term data about the vaccine.
A Phase 3 trial will assess the safety and efficacy of BBIBP-CorV against locally circulating variants of concern (VoCs) in healthy adults. This will be the first trial of this vaccine in an African population, and against the VoCs prevalent in much of southern Africa. The trial will also assess the vaccine's safety and immunogenicity in HIV-infected individuals, which could broaden the indication of the vaccine for use in this population. In addition, it will investigate the potential for co-administration of BBIBP-CorV with seasonal influenza vaccines.
A separate Phase 2 mix and match trial will evaluate the safety and immunogenicity of mixed schedules of BBIBP-CorV and AstraZeneca's COVID-19 vaccine. The trial will investigate the potential of giving two different vaccines which are both likely to feature significantly in Africa's vaccine rollout, which could bring greater flexibility to vaccination campaigns at times of uncertain or fluctuating supplies.
Dr Richard Hatchett, CEO of CEPI, said:
"Only a handful of clinical trials of COVID-19 vaccines have taken place in sub-Saharan Africa, but for vaccines to have the maximum impact they must be evaluated in the populations that will receive them and against the variants those populations are most likely to encounter. 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.
"Through our collaboration with the African Union and Africa CDC, CEPI is working to enhance vaccine R&D and manufacturing on the continent, which includes boosting clinical trial capacity so the region is better equipped to respond to emerging infectious diseases. Investing in high quality clinical trials such as these will fill in immediate gaps in our clinical knowledge, while also strengthening regional health security in the future."
Dr Florian Marks, Deputy Director General of Epidemiology, Public Health and Impact at IVI, said:
"To end the pandemic as quickly as possible, it is vital to evaluate vaccines in a variety of populations and contexts, and to ensure safe and effective vaccines are available to countries everywhere. We are extremely grateful to receive CEPI's support for the ECOVA project, aiming to expand access and delivery of COVID-19 vaccines in Africa. To achieve this goal, IVI and our consortium of partners, the National Institute of Health in Mozambique; icddr,b; the University of Heidelberg; Harvard University; and the University of Antananarivo will work to generate critical clinical data, including the effect of BBIBP-CorV against new variants of concern, vaccination strategies using two different vaccines for two doses, and the use of COVID-19 vaccines in individuals with HIV infection."
Dr Ilesh V. Jani, Director General of the INS (National Institute of Health) in Mozambique, said:
"We are pleased to partner with IVI and our other consortium members on this important study to evaluate the efficacy of COVID-19 vaccines against new variants of concern--particularly the Beta and Delta variants which now account for the majority of infections in our region. The ECOVA project supported by CEPI will have a significant impact on bringing an effective and much-needed vaccine solution to Mozambique and other African countries."
The ECOVA project will be of great importance to Mozambique, further developing the country's clinical trial capacity that has been established in the past decade. Data originating from ECOVA will not only provide information on vaccine efficacy of the BBIBP-CorV product but generate additional epidemiological data on transmission patterns of SARS-CoV-2, which will be valuable for tackling the COVID-19 pandemic."
Dr. Sónia Enosse, Director of Research on Health and Wellbeing, INS
Expanding access to COVID-19 vaccines by filling R&D gaps
ECOVA is the second programme to be funded in response to a CEPI Call for Proposals launched in January 2021 which aims to address current gaps in our clinical knowledge of vaccine performance both now and in the long term, in order to expand access to COVID-19 vaccines as part of the global vaccination rollout.
Examples of such gaps include assessment of the safety and effectiveness of COVID-19 vaccines in pregnant women, infants and children, and immunocompromised populations, as well as studies on booster doses, length of vaccine efficacy, 'mix and match' strategies, and dosing intervals. CEPI is also co-funding a study of COVID-19 vaccine efficacy in immunosuppressed and transplant patients led by Oslo University Hospital in response to this Call for Proposals. In addition, CEPI has previously announced funding to support a mix-and-match study led by the University of Oxford
This funding forms part of CEPI's next 5-year plan, published in March 2021, which aims to reduce or even eliminate the future risk of pandemics and epidemics. As part of this plan CEPI is working to strengthen our defences against COVID-19 and reduce the risk of future coronavirus pandemics, by optimizing our current vaccines, addressing variants of concern, developing next-generation COVID-19 vaccines, and initiating the development of broadly protective or universal coronavirus vaccines.