Positive Results from Afrivac2121 Toxicology Test

The World Health Organization (WHO), Medicines Patent Pool (MPP) and Afrigen Biologics welcome the positive results from the toxicology study of the Afrivac2121 COVID-19 vaccine, an important step in establishing the mRNA technology platform at Afrigen and meeting some of the key goals of the mRNA Technology Transfer Programme. Conducted in line with Good Laboratory Practices and the guidelines of the WHO, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the study demonstrated that Afrivac2121 was well tolerated, with no observed safety concerns.

Strong Safety and Immune Response

The vaccine elicited a strong immune response, generating robust binding and neutralizing antibodies in the animal study. It also did not show any adverse toxicological effects or local/systemic changes following intramuscular administrations. The tested dose was equivalent to the highest planned dose for human administration (100 μg/dose for primary immunization) and followed a regimen consistent with human use—two primary injections plus an additional booster.

Experts Highlight Progress Toward Sustainable mRNA Vaccine Production

“These results mark a significant milestone in our mission to establish a sustainable, South-South driven mRNA research, development and manufacturing platform,” said Caryn Fenner, Executive Manager of the Centre for mRNA Technology Development and Transfer at Afrigen Biologics. “They provide further confidence in the progress of this initiative, ensuring that low- and middle-income countries have the scientific and technological foundation to develop and produce mRNA vaccines.”

“This toxicity study follows the earlier demonstration of immunogenicity and efficacy in preclinical models, comparable to those obtained with commercial mRNA vaccines, confirming that we are on a successful scientific pathway,” said Landry Bertaux, Biologics Expert at MPP. “Each milestone brings us closer to a fully validated mRNA platform that can support regionally developed and produced vaccines and expand access in low- and middle-income countries.”

Boosting mRNA Vaccine Capacity in Low-Income Region

The mRNA platform is currently being transferred by Afrigen Biologics to the 15 Partners of the mRNA Technology Transfer Programme, supporting the development of regionally manufactured mRNA vaccines and strengthening health security in low- and middle-income countries.

More information on www.mrnaProgramme.org

Media contacts:
Gelise McCullough: gmccullough@medicinespatentpool.org
Sarah Mascheroni: mascheronisa@unitaid.who.int