Preclinical evaluation in hamster model of the mRNA COVID-19 vaccine candidate AfriVac 2121 (Wuhan) produced under the WHO/MPP mRNA Technology Transfer Programme.

During the COVID-19 pandemic, access to vaccines in low- and middle-income countries was limited and delayed. To address these disparities, the mRNA Technology Transfer Programme, coordinated and led by the World Health Organization and the Medicines Patent Pool, was launched. A consortium has been set up in South Africa to develop a platform for manufacturing mRNA vaccines. In this study, the preclinical evaluation of the mRNA COVID-19 vaccine candidate, AfriVac 2121 (Wuhan) manufactured in December 2022 was conducted. The hamster model was employed to assess the immunogenicity and efficacy of this COVID-19 mRNA vaccine candidate in comparison to a commercial mRNA vaccine (mRNA-1273, Moderna). Results revealed that a vaccine regimen consisting of two 5 μg doses of AfriVac 2121 (Wuhan) elicited a protective immune response against an ancestral B.1 strain of SARS-CoV-2 similar to that obtained with the mRNA-1273 vaccine. AfriVac 2121 (Wuhan) induced robust humoral immune responses against SARS-CoV-2 and protected hamsters against a SARS-CoV-2 challenge with the B.1 strain. These results have since enabled the further development of this platform for manufacturing mRNA vaccines.