20 Jul 2021
July 20, 2021; Oslo, Norway and Seoul, Republic of Korea: 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.
Chief Executive Officer, CEPI
Deputy Director General of Epidemiology, Public Health and Impact at IVI
Director General of the INS (National Institute of Health) in Mozambique
Director of Research on Health and Wellbeing at the 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.
CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19 CEPI’s work focused on developing vaccines against Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus – it has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X).
During the current pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19 as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation to these vaccines worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a universal vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at http://www.endpandemics.cepi.net.
About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a nonprofit inter-governmental organization established in 1997 at the initiative of the United Nations Development Programme (UNDP). IVI has 36 countries and the World Health Organization (WHO) on its treaty, including Korea, Sweden, India, and Finland as state funders.
Our mandate is to make vaccines available and accessible for the world’s most vulnerable people. We focus on infectious diseases of global health importance such as cholera, typhoid, shigella, salmonella, schistosomiasis, chikungunya, Group A Strep, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as antimicrobial resistance. For more information, please visit https://www.ivi.int
Email: [email protected]
Phone: +44 7387 055214
Email: [email protected]
Phone: +81 2-881-1386