New Delhi (NVI): The World Health Organisation (WHO) has approved emergency use listing (EUL) for the Astrazeneca-Oxford COVID-19 vaccine manufactured by Serum Institute of India (SII) and South Korea’s AstraZeneca-SKBio.
This will facilitate a global rollout of vaccine supplies through Covax to low-income countries.
Taking to Twitter, WHO said, “Today, 2 versions of the AstraZeneca/Oxford #COVID19 vaccine are listed for emergency use, giving the green light for these vaccines to be rolled out globally through #COVAX. The vaccines are produced by AstraZeneca-SKBio of South Korea & the Serum Institute of India.”
Today, 2 versions of the AstraZeneca/Oxford #COVID19 vaccine are listed for emergency use, giving the green light for these vaccines to be rolled out globally through #COVAX. The vaccines are produced by AstraZeneca-SKBio ?? & the Serum Institute of ??
?https://t.co/5NHRcpGxhi pic.twitter.com/BvWM1mrH1S
— World Health Organization (WHO) (@WHO) February 15, 2021
The 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.
“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,” WHO Assistant-Director General for Access to Medicines, Health Products Dr Mariângela Simão said in a statement.
“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,” Simão added.
According to WHO, the process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner.
After those data are submitted, the organization’s team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites, it added.
But in the case of the two AstraZeneca/Oxford vaccines the process took under four weeks. WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability, such as cold chain requirements, the UN agency said.
The vaccine was reviewed on February 8 by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for vaccines use in for all age groups 18 and above.
Notably, the AstraZeneca/Oxford product is a viral vectored vaccine called ChAdOx1-S has been found to have 63.09 per cent efficacy and is suitable for low-and middle-income countries due to easy storage requirements. It is being produced at several manufacturing sites, as well as in the Republic of Korea and India, WHO statement added.
Earlier, WHO listed Pfizer and BioNTech’s Covid-19 shot for emergency use on December 31.
-RJV