The AstraZeneca/Oxford Covid-19 vaccine was listed by the World Health Organization for emergency use on Monday, meaning that it can be rolled out globally through COVAX.
“Today we have even more reason to be hopeful of bringing the pandemic under control,” WHO Director-General Tedros Adhanom Ghebreyesus said during a news briefing in Geneva on Monday. “Today, WHO gave emergency use listing to two versions of the Oxford-AstraZeneca vaccine, giving the green light for these vaccines to be rolled out globally through COVAX.”
Tedros explained that the “two versions” are the same vaccine being manufactured by two different producers – AstraZeneca-SKBio and the Serum Institute of India. They require separate reviews and approvals, as they are being made in different production plants.
Emergency use listing assesses the quality, safety and efficacy of Covid-19 vaccines and is a prerequisite for the vaccines to be part of the COVAX supply, as well as allowing countries to expedite their own regulatory approval, according to a WHO news release, also on Monday.
For the two AstraZeneca/Oxford vaccines, WHO assessed the quality, safety and efficacy data, risk management plans and programmatic suitability in less than four weeks. On Feb. 8, the vaccine was reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), who recommended the vaccine for all groups age 18 and above.
SAGE recommended use of the vaccine for all people ages 18 and older, and that the two doses are administered eight to 12 weeks apart. Their interim recommendations say that it has an efficacy of 63.09% against symptomatic infection.
Along with the Pfizer/BioNTech vaccine, these are the second and third vaccines to receive emergency use listing by WHO, Tedros said. Experts say they could have a major global impact because they cost less and are more easily distributed, since they do not have ultra-cold chain requirements.