- IAVI’s extensive clinical trial experience will be combined with GreenLight COVID-19 vaccine candidate.
- Goal is to broaden and accelerate access to messenger RNA (mRNA) COVID-19 vaccines.
- Phase 1 trial planned for late Q1 2022.
- Plan speeds creation of vaccines in Africa, for Africa, and suitable for use in low-income countries globally.
NEW YORK, Nov. 30, 2021 /PRNewswire/ — GreenLight Biosciences has partnered with the non-profit scientific research organization IAVI to work together on a Phase I clinical trial in Africa. IAVI and its partners were among the first to conduct HIV vaccine clinical trials in Africa, and since then, IAVI has sponsored more than 60 vaccine and biologics clinical trials in 13 countries. IAVI has built partnerships with centers of excellence for clinical research in five sub-Saharan African countries, and is developing vaccines and biologics against HIV, COVID-19, tuberculosis, Lassa fever, snakebite, and other diseases.
This partnership will help advance GreenLight’s mRNA COVID-19 vaccine candidate. More vaccines to prevent COVID-19, especially those suitable for use in low-income countries, will be an ongoing global health need.
GreenLight will provide its vaccine candidate for the trial and will make preparations for large-scale manufacturing of the vaccine.
IAVI’s experience in running clinical studies, planned for late Q1 2022, will ensure that the trial meets regulatory standards. IAVI will also be responsible for overall clinical trial management.
“Only about 6% of people in low-income countries have been vaccinated against COVID-19. This situation leaves hundreds of millions of people vulnerable to severe disease and could lead to the continued emergence of more dangerous viral variants. It is crucial for vaccine development to focus on overcoming inequities in access to SARS-CoV-2 vaccines and address the still unmet needs of low- and middle-income countries, which have mainly had to rely on imported vaccines developed elsewhere when they are available at all,” said IAVI President and CEO Mark Feinberg.
This partnership aims to accelerate the timeline for manufacturing and deployment of GreenLight’s COVID-19 vaccine candidate to Africa and potentially for export from Africa.
“There is an urgent need to develop vaccines in Africa, for Africa,” said GreenLight CEO Andrey Zarur. “Our vaccine trial, in partnership with IAVI, will open the way to make vaccines that are available to everybody, not just citizens of rich countries.If we don’t vaccinate the world quickly, then the ongoing emergence of new variants could compromise the tremendous progress made so far in the COVID-19 response.”
The trial is expected to start once research sites and clinical research partners in Africa have been finalized, and after ethical and regulatory approvals. This clinical trial will harness capabilities and expertise in Africa, and builds on long-standing efforts to nurture this capacity by a variety of collaborative research organizations and global health funders. By engaging African clinical investigators and communities affected by COVID-19 early in clinical development, GreenLight and IAVI aim to ensure that the vaccine candidate will be suitable and effective for African populations. Moreover, enlisting African research partners in vaccine development will further strengthen capacity on the continent to address emerging infectious disease threats beyond COVID-19.
This partnership builds on IAVI’s mission to translate scientific discoveries into affordable, globally accessible public health solutions. It also delivers part of GreenLight’s ambition to help vaccinate the world against COVID-19, detailed in its Blueprint To Vaccinate The World published in March 2021. Both organizations are committed to vaccine equity and envision a world capable of producing enough mRNA vaccine doses for billions of people a year. This vision aligns with calls by the African Union, Africa CDC, the Coalition for Epidemic Preparedness Innovations, and others for concrete actions to increase vaccine manufacturing capacity in Africa, not just for COVID-19, but for other infectious diseases.
