The World Health Organization has approved two versions of AstraZeneca/Oxford Covid 19 vaccine for emergency use, giving the green signal for these versions to be rolled out globally through Covid-19 Vaccines Global Access (Covax). The two versions have been listed in WHO’s Emergency Use Listing (EUL).
It may be noted that AstraZeneca and Oxford vaccine is being rolled out across India. The Serum Institute of India is manufacturing the vaccines in the country.
The WHO has said that the AstraZeneca/Oxford product is a viral vectored vaccine called ChAdOx1-S [recombinant]. It is being produced at several manufacturing sites including Republic of Korea and India. The WHO added that ChAdOx1-S has been found to have 63.09% efficacy and is suitable for low- and middle-income nations due to easy storage requirements.
Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, said, “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.”
‘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,” added Dr Simao.
According to the UN agency, the Emergency Use Listing (EUL) assesses the quality, safety and efficacy of Covid vaccines. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.
The WHO has stressed that the 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,” reads the WHO press release.
“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,” informed the WHO.
The agency has informed that the vaccine was reviewed on February 8, 2021, by WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization, 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.