World Health Organisation (WHO) says it has added the two versions of AstraZeneca/Oxford vaccine to the Emergency Use Listing (EUL).
This listing means the vaccines can now be rolled-out globally under the COVAX program.
WHO’s EUL assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facility vaccine supply.
COVAX is an initiative co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO. It aims to accelerate the development and manufacture of COVID-19 vaccines while also ensuring a fair and equitable distribution across the world.
The listing also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
In a statement dated 15 February 2020, the health body said “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,” read the statement.
More countries to start receiving vaccine
Speaking on the issue, WHO Assistant-Director General for Access to Medicines and Health Products Dr Mariangela Simao 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.”
Despite being listed by WHO, the vaccine has come under fire especially on the alleged ineffectiveness against the South African variant.
This has seen the South Africa government halting its roll-out plans as it seeks to exchange AstraZeneca with Johnson and Johnson vaccines.
In the case of the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programatic 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).
According to WHO, the SAGE recommended the vaccine for all age groups 18 and above.
WHO emergency use listing
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020. Get more Covid-19 Stats from CovidZW.info #WhereAreOurVaccinesZW #OpenCovidContracts