The World Health Organisation (WHO) on Monday gave emergency use approval (EUA) to two versions of AstraZeneca-Oxford's COVID-19 vaccines, allowing these shots to be rolled out globally through COVAX. The vaccines are being produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
The apex health organisation has assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements of these two AstraZeneca- Oxford vaccines. The process took under four weeks.
The vaccine was reviewed on February 8 by WHO's Strategic Advisory Group of Experts on Immunisation (SAGE), which makes recommendations for vaccines' use in populations (i.e. recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women). The SAGE recommended the vaccine for all age groups 18 and above.
The AstraZeneca-Oxford product is a viral vectored vaccine called ChAdOx1-S [recombinant]. It is being produced at several manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been found to have 63.09 per cent efficacy and is suitable for low and middle income countries due to easy storage requirements.
"Countries with no access to 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 Mariangela Simao, WHO Assistant-Director General for Access to Medicines and Health Products.
"But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things - a scale-up of manufacturing capacity, and developers' early submission of their vaccines for WHO review," Simao added.
WHO's Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
Previously, WHO gave emergency use approval to Pfizer-BioNTech COVID-19 vaccine on December 31, 2020.