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AVAREF Workshops Accelerating COVID-19 Vaccine Access in Africa
Africa Medicines Agency (AMA) Treaty Update
by David Mukanga
Bill and Melinda Gates Foundation

s part of the African Union guidance on emergency regulatory authorization of COVID vaccines, the Africa Vaccine Regulatory Forum (AVAREF) convened several workshops in 2021 with Africa member states (see below). These workshops were intended to enable regulators to rely on the World Health Organization (WHO) Emergency Use Listing (EUL) without having to undertake their own reviews, and in turn accelerate national emergency use authorization and access to these vaccines.

The regulators accessed the full dossiers and WHO Prequalification (PQ) assessment reports for these vaccines through a WHO portal, after signing a confidentiality agreement. The workshops were facilitated by members of the WHO PQ team followed by extensive Q&A sessions. The facilitated workshops covered six vaccines produced by AstraZeneca-Serum Institute of India and other organizations.
AVAREF facilitated technical workshops to date
Source: WHO Regional Office for Africa, 2021.
The map below shows the COVID-19 vaccine authorizations across Africa as of September 3, 2021.
COVID-19 vaccine authorisation status in Africa
Source: WHO Regional Office for Africa, 2021.

AVAREF Joint Reviews of Clinical Trials

AVAREF facilitates clinical trial joint reviews between product sponsors, regulators, and ethics committees. After their June 2021 update meeting with industry and product sponsors, sponsors expressed interest in using the AVAREF platform in the coming months for eight vaccine candidates that target a range of conditions including COVID-19, tuberculosis, Lassa fever, and Ebola, among others.

Previous AVAREF facilitated joint reviews are shown below:

AVAREF has conducted multiple clinical trial joint reviews across disease areas, with 3 reviews in the past 12 months
Source: WHO Regional Office for Africa, 2021.
All these trials started and were completed with the exception of the 2020 and 2021 trials that are still underway.

Africa Medicines Agency (AMA) Treaty

In August 2021, the African Union (AU) obtained the 15 country ratifications of the treaty establishing the AMA, which is the number required for the AU to proceed to establish the agency. Of the 15 countries that have ratified the treaty, 11 (Algeria, Benin, Burkina Faso, Ghana, Guinea, Mali, Namibia, Niger, Rwanda, Seychelles, and Sierra Leone) have deposited the signed treaty at the AU Commission, while four countries (Cameroon, Gabon, Morocco, and Tunisia) have yet to do so. AMA will become a legal entity of the AU within 30 days of the deposit of the 15th signed treaty at the AU.

The AU and WHO are working together on the preparatory phase for establishing the AMA, including where it will be hosted, identifying the inaugural director general and secretariat staff, and defining business processes, funding sources, and other details.

We could see the AMA open its doors within the next year. This is simply amazing given how quickly things have moved since the AMA was endorsed to start the treaty ratification journey at the Heads of State Summit in 2019. Honorable Michele Sidibé and the AU have done a commendable job in driving the ratification process during the past year. We should all embrace the AMA and support Africa as it establishes this agency that will transform in monumental ways the continent’s regulatory ecosystem once established.

A more detailed article on AMA will follow in a subsequent issue of Global Forum.