The World Health Organization (WHO) today listed two versions of the AstraZeneca / Oxford COVID-19 vaccine for urgent use, giving the green light for these vaccines to be distributed globally through COVAX. Vaccines are manufactured by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
The WHO Emergency Use List (EUL) evaluates the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for the supply of COVAX Facility vaccines. It also allows countries to speed up their regulatory approval to import and administer COVID-19 vaccines.
“Vaccine-free countries to date will finally be able to start vaccinating their health workers and at-risk populations, 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 entry. To do that, we need two things – a high degree of production capacity and early delivery of vaccines to developers for WHO review. ”
The WHO EUL process can be carried out quickly when vaccine manufacturers submit the complete data required by the WHO in a timely manner. Once that data is submitted, the WHO can quickly gather its assessment team and regulators from around the world to evaluate the information and, when necessary, conduct inspections at the production sites.
In the case of the two AstraZeneca / Oxford vaccines, the WHO assessed quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements. The process took less than four weeks.
The vaccine was reviewed on February 8 by the WHO Strategic Advisory Group on Immunization Experts (SAGE), which makes recommendations for the use of vaccines in populations (ie recommended age groups, shooting intervals, advice for specific groups such as women pregnant and lactating). SAGE recommended the vaccine for all age groups 18 and up.
The AstraZeneca / Oxford product is a vector viral vaccine called ChAdOx1-S [recombinant]. It is being produced in several production areas as well as in the Republic of Korea and India. ChAdOx1-S has been found to have 63.09% efficiency and is suitable for low and middle income countries due to light storage requirements.
WHO Emergency Use List
The Emergency Use List (EUL) procedure assesses the suitability of new health products during public health emergencies. The goal is to make medicines, vaccines and diagnostics as soon as possible to address the urgency, respecting the strict criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that may result from using the product against any potential risk.
The EUL path includes a rigorous evaluation of late phase II and phase III clinical trial data, as well as additional essential data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams taking into account the current body of evidence on the vaccine under consideration, plans for monitoring its use and plans for further studies.
As part of the EUL process, the vaccine company should be committed to continuing to generate data to enable the WHO to fully license and prequalify the vaccine. The WHO prequalification process will evaluate additional clinical data generated from vaccine trials and their repeated placement to ensure that the vaccine meets the necessary quality, safety and efficacy standards for wider availability.
The WHO also listed the Pfizer / BioNTech vaccine for emergency use on December 31, 2020.
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