Around the Globe

African Medicines Regulatory Harmonization
Plans to Collaborate on COVID Vaccine Emergency Use Authorization
David Mukanga
Bill and Melinda Gates Foundation

he 2nd African Medicines Regulatory Harmonization (AMRH) Week took place virtually beginning December 9, 2020, due to wide travel restrictions in many countries because of the COVID-19 pandemic. Attended by more than 120 participants from Africa and other parts of the world, these discussions included collaboration among regulators and ethics committees regarding COVID-19 clinical trials review, preparations for authorization and monitoring of the safety of COVID vaccines, as well as the listing of medical devices, including in vitro diagnostics and personal protective equipment (PPEs) as part of COVID-19 response.

In panel discussion, Honorable Michel Sidibe (former head of UNAIDS), Ibrahim Mayaki (CEO of AUDA-NEPAD), Murray Lumpkin from the Gates Foundation, and H.E. Amira Elfadil Mohammed Elfadil from the African Union Commission, emphasized the importance of African Union member states rallying behind the treaty to establish an African Medicines Agency (AMA), and getting it ratified. To date, four countries have ratified the AMA treaty since the treaty was approved by the heads of state and government in February 2019. Ratification by a minimum of fifteen countries is required for AMA to be established. (It normally takes five to seven years for Africa Union treaties to be ratified by the required minimum number of countries.) The important role of the AMRH initiative in galvanizing harmonization in Africa and its potential to provide a solid foundation for the AMA were underscored, and opportunities presented by the establishment of the African Continental Free Trade Area (AfCFTA) for AMA to facilitate regulatory standards and movement of medical products across the trade area were also discussed.

The continental technical committees provided updates on their work in facilitating COVID clinical trial application reviews, and product assessments information sharing among regulators. The meeting also occasioned the announcement that, under the leadership of WHO and the AUDA NEPAD’s 3S program, African regulators are working side-by-side with national vaccine programs to establish mechanisms for vaccine safety monitoring.

AVAREF Participation in WHO EUL of Candidate COVID-19 Vaccines

The 27th WHO regulatory update on COVID-19 issued on January 23 provided the status of various vaccines with regard to their application for WHO Emergency Use Listing (EUL).

The COVAX facility is a global effort coordinated by GAVI The Vaccine Alliance, the World Health Organization, and CEPI (Coalition for Epidemics Preparedness Innovations), and supported by governments and global health and philanthropic organizations, to facilitate innovative and equitable access to COVID-19 diagnostics, treatments and vaccines. Given that the COVAX facility will be a major supplier of vaccines (along with an African Union facility and bilateral arrangements) for several African countries, WHO EUL assessment reports will be key documents for regulatory reliance. The African Vaccine Regulatory Forum (AVAREF) will serve as a platform for the joint assessment of the WHO COVID vaccines EULs by African regulators to accelerate national decisions. The hope is that bringing national regulatory authorities together will enable expeditious review and reliance on the WHO EUL in issuing their own decisions, accelerate in-country administrative steps and issuance of import permits, and further alignment of risk management plans to monitor vaccine performance. These joint assessments will be organized within regional economic communities (RECs), building on the experience of REC harmonization initiatives. It is not yet clear how these reviews will be triggered (by manufacturer, COVAX, WHO, or others), but WHO continues to lead discussions to clarify these issues.