Africa Regulatory Taskforce has Endorsed the Emergency Used Listing for Two Versions of the AstraZeneca-Oxford Vaccine (AstraZeneca-SKBio in South Korea and Serum Institute of India)
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 Vaccine 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 Used Listing /Pre-qualification (EUL/PQ) approval.
– Scenario 2: COVID-19 vaccines that have received approval from one or several Stringent Regulatory Authorities (SRAs) but not yet through WHO EUL/PQ.
– Scenario 3: COVID-19 vaccines that have received neither of the above.
Because WHO has granted approval for the two versions of the AstraZeneca-Oxford vaccine (AstraZeneca-SKBio in South Korea and Serum Institute of India) (Scenario 1), the African Union countries are permitted to waive the AVAREFled joint review process and commit to reliance directly on the WHO EUL/pre-qualification process (https://www.who.int/news/item/15-02-2021-who-lists-two-additional-covid-19-vaccines-for-emergency-use-and-covax-roll-out).
The Africa Regulatory Taskforce will be reviewing rolling data for the Sputnik V (Gamaleya National Center) and Ad26. COV2.S (Johnson and Johnson) to ensure that phase III clinical trial safety, efficacy data and severe adverse events (SAEs) requirements are met by vaccine developers. These two COVID-19 vaccines fall under scenario 3. The evaluation outcome will be provided after the review process is completed.
|Statement on Africa Regulatory Taskforce – ENG