The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisation’s (WHO) African Vaccine Regulatory Forum (AVAREF) to enable and provide support for an effective regulatory framework for COVID-19 Vaccines in Africa.
In order to properly guide Member States, the Africa Regulatory Taskforce has developed a framework (https://africacdc.org/download/guidance-on-emergency-expedited-regulatory-authorisation-and-access-to-covid-19-vaccines-in-africa/) for market authorisation of COVID-19 vaccines, which include three scenarios:
• Scenario 1: COVID-19 vaccines that have received WHO Emergency Use Listing/Pre-qualification (EUL/PQ) approval.
• Scenario 2: COVID-19 vaccines that have received approval from one or several recognized Stringent Regulatory Authorities (SRAs) but not yet through WHO EUL/PQ.
• Scenario 3: COVID-19 vaccines that have received neither of the above.
The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the COVID-19 Vaccine BIBP/ Sinopharm, the Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorization for the vaccine (see scenario #1) and the specification is 0.5ml/dose, 1 dose/vial; or 2 doses/vial; or 5 doses/vial. As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1. For details see (https://extranet.who.int/pqweb/vaccines/who-recommendation-covid-19-vaccine-bibp).
The Africa Regulatory Taskforce will discuss clinical data on Covaxin from phase 1, 2 and 3 clinical trials (see scenario #3) to ensure that phase 3 safety, efficacy data requirements are met by the vaccine developer.
Africa CDC will share the outcome of the review with all African Union Member States once we complete the processes.
For further information and queries, please contact Dr Nicaise Ndembi at NicaiseN@africa-union.org
|AU and Africa CDC has endorsed the Emergency Used of Sinopharm||Download|