Guidance on Expedited Regulatory Authorisation Process for Emergency use of COVID-19 Vaccines in Africa

PREAMBLE

CONSCIOUS of the fact that the COVID-19 outbreak was declared a public health emergency of international concern (PHEIC) by the World Health Organization (WHO) on 30 January 2020, and declared a pandemic on 11 March 2020, having infected over 91 million persons and caused the deaths of more than 2 million persons globally – including more than 3 million cases and 73,400 deaths on the African continent.

RECALLING that during the 22 February 2020 emergency meeting of African Ministers of Health, Ministers endorsed the Africa Joint Continental Strategy for COVID-19 Outbreak, including Africa CDC’s leadership role in coordinating the response on the continent.
FURTHER RECALLING that on 24-25 June 2020, Africa CDC convened over 3000 political leaders and technical experts to discuss COVID-19 vaccine needs on the continent and regional opportunities for driving development, manufacture, distribution and uptake, and translated the results of the discussion into the COVID-19 Vaccine Development and Access Strategy.
FURTHER RECALLING that on 20 August 2020, the African Union Bureau of Heads of State and Government, chaired by His Excellency President Cyril Ramaphosa of South Africa, endorsed the Continental COVID-19 Vaccine Development and Access Strategy aimed at the “Successful immunisation of a critical mass of the African population with one or several safe and efficacious COVID-19 vaccines.”
RECOGNISING the efforts by African Union Member States in response to the COVID-19 pandemic, with a focus on how the continent can prepare for the research and development, manufacturing, procurement, financing, regulatory review, delivery, and uptake of a potential COVID-19 vaccine.