15th February 2021 – WHO issued emergency use listing for the COVID-19 vaccines produced by SKBio (Republic of Korea) and the Serum Institute of India (India), two versions of the AstraZeneca/Oxford vaccine, to be rolled out globally through COVAX Facility.
WHO’s Emergency Use Listing (EUL) mechanism assesses the quality, safety and efficacy of vaccines during public health emergencies, and allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines; it is also a prerequisite for COVAX Facility financing and supply. “Countries with no access to COVID-19 vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
The WHO EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan and can make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The process took under four weeks. The vaccine was also reviewed on 8 February by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which recommended its use for age groups above 18 years old.
The AstraZeneca/Oxford product is a recombinant viral vectored vaccine called ChAdOx1-S, being produced at several manufacturing sites, including the Republic of Korea and India. ChAdOx1-S has been found to have 63.09% efficacy and is suitable for low- and middle-income countries due to easy storage requirements in a common refrigerator at 4-6 degrees Celsius.
WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020.