Bringing vaccine equity to Africa through ‘tech and reg’ transfer

Michael Pfleiderer, Ph.D., Principal Consultant and Senior Director

Efforts to address Covid-19 worldwide through vaccination have been severely stalled in Africa, where, as of early 2022, just 10% of the population across the continent had been vaccinated. In May 2021, following a summit organized by the African Union, the Africa Centres for Disease Control (CDC) launched the Partnerships for African Vaccine Manufacturing (PAVM) Task Force.

To further advance the objectives, several African leaders and the president of the European Commission, Ursula von der Leyen, held a meeting with Uğur Şahin, CEO and co-founder of BioNTech, to discuss the transfer of the company’s technology to the African continent to enable sustainable vaccine development. The meeting, convened by a non-profit organization called kENUP Foundation, has taken the efforts to transform vaccine manufacturing in Africa to the next level.

The infrastructure needed to enable this technology transfer also requires the establishment of scientific and regulatory standards to enable sustainable vaccine manufacturing.

White Book sets out vaccine framework

A team of regulatory experts from Biopharma Excellence were asked to develop the scientific and regulatory framework for this “tech and reg” transfer. The result is a detailed White Book that evaluates the challenges faced and tools needed to achieve sustainable vaccine manufacturing in Africa. The White Book provides details as to how vaccine manufacturing in Africa could be achieved in accordance with an existing regulatory framework, agreed on globally at the level of the World Health Organization.

By combining the transfer of technical and regulatory components, production of mRNA, recombinant protein-based and/or other SARS-CoV-2 vaccines should be able to quickly get underway. As a starting point, the tech and reg transfer approach takes advantage of the well-established liaison between the European Medicines Agency (EMA), EU national regulatory agencies and the WHO in terms of establishing and agreeing on licensing procedures.

As the White Book notes, vaccines regulated by EMA and licensed by the EC are eligible for WHO pre-qualification, which allows for these vaccines to be purchased by organizations and countries. Since SARS-CoV-2 vaccines licensed in the EU are listed for emergency use by WHO (the pandemic equivalent of a WHO prequalified vaccine), the manufacturing process for these vaccines is, in principle, also covered. This would allow for the short-term establishment of manufacturing of fully tested and licensed SARS-CoV-2 vaccines in Africa.

Manufacturing goals outlined

The White Book was handed to the African CDC in November 2021 for comment and information and was accepted in its entirety. On February 16, 2022, the project was launched for the general public and kENUP formally handed the project proceedings over to BioNTech as the first technology provider supporting the vaccine equity for Africa project. The plan is to have the African SARS-CoV-2 vaccine manufacturing process, which will be identical to the  BioNTech process  established in Marburg, Germany, fully functional by the end of 2022.

The longer-term goal is to support African states with a sustainable regulatory system to support the manufacture of other vaccines, including for neglected tropical diseases. The objective is also to increase the capacity of national medicines regulatory authorities and strengthen the administrative, structural, and technical elements of medicines regulation.

Experts from Biopharma Excellence are working closely with the governments of several African countries to translate the tech and reg objectives into practice.

As the project moves into next stages, it will require further expertise from a scientific, project management and political point of view.

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