WHO Gives Emergency Approval to Oxford Vaccine; Why It’s Important

The World Health Organization (WHO) granted an emergency use authorization to two versions of AstraZeneca-Oxford’s coronavirus vaccine on Monday, 15 February, paving the way for these candidates to be rolled out globally through COVAX.

The vaccines are produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India. Here is everything you need to know about the approval.

Why Is This Authorisation Important?

To put it simply, the vaccines will now be able to reach some of the world’s poorest countries which haven’t had access to these facilities yet. Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, said in a statement,

“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.”

Dr Mariângela Simão

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.

Why Is the Oxford Vaccine a Good Option for COVAX?

The vaccine has been made available at not-for-profit during the pandemic, and the WHO-COVAX facility, which will be distributing vaccines to the developing and under developed countries, is relying heavily on the Oxford AstraZeneca jab.

The vaccine is easy to manufacture, transport and store at a regular fridge temperature of 2-8 degrees Celsius. This makes it easy to be deployed in existing vaccine distribution setups, as opposed to, for instance, the Pfizer-BioNTech candidate that needs to be stored at minus 60 degree C to minus 90 degree C

In India, Serum Institute is manufacturing the vaccine and will be providing a large chunk to the COVAX facility and directly to developing countries.

What Does the Approval Entail?

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, the statement read.

“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 (such as 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,” the WHO said.

What Did the WHO Review of the Vaccine Find?

The World Health Organisation's Advisory Group (SAGE) had said that the Oxford AstraZeneca is safe and effective after a review, as FIT had earlier reported. Importantly, it has approved the use of the vaccine for all above the age of 18 at a dosing regimen of 8 to 12 week interval. Currently in India, the vaccine named as Covishield and manufactured by Serum Institute is administered at a 4 week interval.

It has deemed the vaccine safe for those above 65, and recommended its use even in areas where various coronavirus variants are present.

Has Any Other Vaccine Candidate Received Such Authorisation by the WHO?

Yes, the WHO also listed the Pfizer/BioNTech vaccine for emergency use on 31 December 2020 - making it the first COVID vaccine candidate to receive such an authorisation.

The WHO noted that the vaccine requires storage using an ultra-cold chain -- it needs to be stored at minus 60 degree C to minus 90 degree C. This requirement makes the vaccine more challenging to deploy in settings where ultra-cold chain equipment may not be available or reliably accessible.

For that reason, WHO is working to support countries in assessing their delivery plans and preparing for use where possible. “WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment.”