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WHO approves Oxford-AstraZeneca vaccines made in India and South Korea

Emergency approval given for global COVAX programme

Salil-oxford-covishield-serum-vaccine-vial-vaccination-2 The Covishield vaccine, developed by Oxford University and AstraZeneca and made in India by the Serum Institute of India | Salil Bera

In a move that allows vaccines to be doled out to much of the developing world, the World Health Organisation on Monday granted emergency approval for the Oxford-Astrazeneca vaccine manufactured by India’s Serum Institute and South Korea’s AstraZeneca-SKBio.

The World Health Organization (WHO) today listed two versions of the AstraZeneca/Oxford COVID-19 vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through COVAX. The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.

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.

“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 Mariângela Simão, 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.”

WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements, of the vaccine in a process that took under four weeks.

The vaccine was reviewed on 8 February by WHO’s Strategic Advisory Group of Experts on Immunization (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.

WHO also listed the Pfizer/BioNTech vaccine for emergency use on December 31 2020.

The COVAX programme, led by the Coalition for Epidemic Preparedness Innovations (CEPI), the Global Alliance for Vaccines and Immunizations (GAVI) and WHO, seeks to distribute two billion doses across the world by the end of 2021.  


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