The World Health Organization (WHO) today listed two versions of the AstraZeneca / Oxford COVID-19 emergency vaccine, giving the green light to these vaccines that can be rolled out worldwide by COVAX. The vaccines are manufactured by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
WHO Emergency Use List (EUL) evaluates the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for the vaccination of COVAX facilities. It also enables countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“Countries with no access to vaccines so far will eventually be able to vaccinate their health workers and populations, which will contribute to the goal of the COVAX facility to distribute fair vaccination,” said Dr. and health products.
‘But we need to keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do this, we need two things: a scaling up of manufacturing capacity, and developers must submit their vaccines in good time for the WHO investigation. ‘
The WHO EUL process can be carried out quickly when vaccine developers submit the complete data required by the WTO on time. Once the data has been submitted, the WHO can quickly put together its evaluation team and regulators from around the world to assess the information and, if necessary, carry out inspections on manufacturing works.
In the case of the two AstraZeneca / Oxford vaccines, the WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, as well as the requirements for cold chain. The process took less than four weeks.
The vaccine was reviewed on 8 February by the WHO’s Strategic Advisory Group on Immunization (SAGE), which makes recommendations for the use of vaccines in populations (ie recommended age groups, intervals, advice for specific groups such as pregnant and lactating women). The SAGE recommended the vaccine for all age groups 18 and older.
The AstraZeneca / Oxford product is a viral vector vaccine called ChAdOx1-S [recombinant]. It is manufactured on various manufacturing sites, as well as in the Republic of Korea and India. ChAdOx1-S has been found to be 63.09% efficient and suitable for low- and middle-income countries due to easy storage requirements.
WHO list of emergency use
The Emergency Listing Procedure (EUL) assesses the suitability of new health products during public health emergencies. The aim is to make medicines, vaccines and diagnoses available as soon as possible to address the emergency, while meeting strict criteria of safety, efficacy and quality. The evaluation weighs the threat of the emergency as well as the benefit that the use of the product will have against any potential risks.
The EUL route involves a careful assessment of late-stage and phase III clinical trial data, as well as significant additional data on safety, efficacy, quality, and a risk management plan. These data are reviewed by independent experts and WHO teams who are considering the current evidence on the vaccine being considered, the plans for monitoring its use and plans for further studies.
As part of the EUL process, the company manufacturing the vaccine must commit to continuing to generate data in order to enable full licensing and the WTO’s pre-qualification of the vaccine. The WHO pre-qualification process will assess additional clinical data generated from vaccine trials and deployment on an ongoing basis to ensure that the vaccine meets the necessary standards of quality, safety and efficacy for wider availability.
WHO also listed the Pfizer / BioNTech emergency vaccine on 31 December 2020.