Technological Innovation for African Development – Enhancing Africa’s Vaccine Manufacturing Capacity
ES Nwauche
In a continent where appeals to
the global community for exceptions and exemptions from the incidence and
obligations of critical goods and service is the norm, it is gratifying to note
the promise of enhanced cooperation towards developing local manufacturing
capacity. The mRNA Technology Transfer Hub Programme Cape Town is a response to
vaccine inequities by building African capacity to address inequities in access
to COVID-19 vaccines. The mRNA hub aims
to establish sustainable, locally-owned manufacturing capabilities for Africa. Even
though its initial focus is on mRNA Covid-19 there appears to be a strong
possibility of developing other mRNA vaccines against important diseases that
threaten Africa, such as Malaria.
The mRNA Technology Transfer Hub was
established in June 2021 by the World Health Organisation (WHO) and its
partners. It will assist in transferring technology to many low, and medium-income
countries (LMIC) to enable Covid-19 mRNA vaccine manufacture. The South African
hub comprises Afrigen Biologics, the South African Medical Research Council
(SAMRC), and the partially state-owned entity BIOVAC, a vaccine manufacturer.
Afrigen is mandated to establish the vaccine production technology, SAMRC
provides the research, and Biovac is the first manufacturing spoke. The
recipients of the technology from Africa include Egypt (BioGenric Pharma SAE);
Nigeria ( Biovaccines Nigeria Ltd); Senegal (Institute Pasteur de Dakar); Tunisia
( Institut Pasteur de Tunis); and a yet-to-be-named Kenyan entity.
In 2022 Cape Town-based
biotechnology company Afrigen Biologics announced that it had successfully
produced a lab-scale batch of a Covid-19 vaccine using the new mRNA vaccine
technology. The lab batch is “reverse engineering” of Moderna’s vaccine, an
important milestone. Since Moderna announced it would not enforce its
intellectual property rights, this Lab batch will not be saddled with IP
issues. In addition, the hub is
developing second-generation vaccine technologies whose IP rights will be held
by the hub but will be freely available.
Commercialising AFRIGEN’s
Vaccines depends on the capacity to certify the vaccines in Africa. To do that,
a local facility must have Good Manufacturing Practices (GMP) certification,
and Afrigen aspires to acquire that capacity. Vaccines, until recently, could
only be certified by entities outside Africa. In October 2022 the World Health Organisation
issued a Maturity Level 3 (ML3) to the South African Health Products Regulatory
Agency (SAPHRA) that enables the regulatory authority to license the commercial
production of vaccines. The ML3 status recognises a stable, well-functioning
and integrated regulatory system that is needed to ensure the quality, safety,
and effectiveness of imported and/or locally manufactured vaccines. In addition to SAPHRA, Egypt’s Egypt Drug
Authority (EDA); Nigeria’s National Agency for Food and Drug Administration
(NAFDAC), and Ghana’s Food and Drug Authority (FDA) all operate at ML3 status. While
Egypt and South Africa are regulating the production of vaccines, Ghana and
Nigeria are not regulating the production of vaccines.
The Cape Town Hub represents a
milestone in recent regional efforts in technological collaboration to build
Africa’s innovation ecosystem. Much more must be done to ensure more cooperation
in vaccine manufacturing and regulatory certification.
Comments
Post a Comment