The World Health Organization(WHO) gave emergency use approval to AstraZeneca’s Covid-19 vaccines on Monday, allowing distribution to some of the world’s poorest countries to begin.
A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
“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’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.
The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner. Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.
In the case of the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process 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% efficacy and is suitable for low- and middle-income countries due to easy storage requirements.
Nearly 109 million people have been reported to be infected by the novel coronavirus globally and more than 2.5 million have died, according to a Reuters tally.
Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.
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