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Mozambique: Country to host ECOVA clinical trials of Sinopharm Covid-19 vaccine
3:29 CAT | 21 Jul 2021
File photo: O País
Mozambique is to host two clinical trials of China’s Sinopharm vaccine as part of the ECOVA initiative to expand the distribution of vaccines against Covid-19 in Africa, in an effort to assess their effectiveness against new variants of the coronavirus that causes the disease.
The clinical trials, which are to begin soon in Maputo and Beira, the country’s second city, are to be led by Mozambique’s National Institute of Health (INS) in collaboration with the International Vaccine Institute (IVI), according to a statement from the The Coalition for Epidemic Preparedness Innovations (CEPI).
The first interim results are expected before the end of this year and participants in the trials are to be monitored for two years to gather important long-term data on the vaccine, it adds.
Ina Phase 3 strial, “the safety and efficacy of BBIBP-CorV against locally circulating variants of concern (VoCs) in healthy adults” will be assessed, the statement says, giving the scientific name of the vaccine.
” This will be the first trial of this vaccine in an African population, and against the VoCs prevalent in much of southern Africa,” it goes on. ” 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, meanwhile, “evaluate the safety and immunogenicity of mixed schedules of BBIBP-CorV and AstraZeneca’s COVID-19 vaccine ” – which, as CEPI notes, 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..”
According to the news release, this new clinical trials programme 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 ,,” it stresses.
Up to 170 million doses of BBIBP-CorV are to be distributed, according to an agreement announced on 12 July, with the vaccine already being administered in more than 50 countries worldwide.
“However there have been no clinical trials of BBIBP-CorV in African populations or against the variants of concern circulating in southern Africa,” the statement explains. ” 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 immunisation programmes”.
Richard Hatchett, CEO of CEP, is also quoted in the statement.
“Only a handful of clinical trials of COVID-19 vaccines have taken place in sub-Saharan Africa,” he says. “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 director-general of Mozambique’s National Institute of Immunology (INS), Ilesh V. Jani, stressed that this is an “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 consortium is led by the International Vaccine Institute, working in partnership with Mozambique’s Instituto Nacional de Saúde (INS), the International Centre for Diarrhoeal Disease Research, Bangladesh, the University of Heidelberg, Germany, Harvard University, USA, and the University of Antananarivo, in Madagascar.
ECOVA is the second programme to be funded with a focus on addressing current gaps in scientific knowledge about vaccine performance, in the short and long term, to expand access to Covid-19 vaccines as part of the global immunisation effort.
Among gaps already identified are the safety and efficacy of the vaccines in pregnant women, infants and children and immunodepressed populations, as well as studies on booster doses, duration of vaccine efficacy, vaccine type combination strategies or dosing intervals.
We’re pleased to announce a new clinical research program with @CEPIvaccines aiming to expand access to COVID-19 vaccines in Africa 🌍
Learn more about ECOVA, led by IVI with @instituto_ins @icddr_b @UniHeidelberg @Harvard & University of Antananarivo 👉 https://t.co/feyFnruYqa
— International Vaccine Institute (IVI) (@IVIHeadquarters) July 20, 2021
Source: Lusa
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