WHO lists AstraZeneca vaccine for emergency use

In a statement released this week, the World Health Organisation (WHO) has announced it has approved two versions of the AstraZeneca/Oxford Covid-19 vaccine, as produced by AstraZeneca-SKBio from South Korea and the Serum Institute of India, for emergency use, giving the go-ahead for these vaccines to be rolled out through COVAX.

“We have been waiting for this finale milestone,” says Serum Institute of India CEO Adar Poonawalla.

“I am happy and relieved that with the WHO’s EUL [Emergency Use Listing] we will be able to stary the deliveries to African and other low and middle-income countries immediately.

“Countries with a large population must be protected as soon as possible.”

According to the statement released by WHO, the quality, safety and efficacy, risk management plans and programmatic suitability, such as cold chain requirements, of the vaccine was assessed, the process taking under four weeks.

Reportedly, the vaccine was reviewed on 8 February by WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE), who recommended the vaccine for all age groups 18 and above.

As reported by ABC News, WHO Director-General, Tedros Ghebreyesus told a news briefing: “We now have all the pieces in place for the rapid distribution of vaccines. But we still need to scale up production.

“We continue to call for Covid-19 vaccine developers to submit their dossiers to WHO for review at the same time as they submit them to regulators in high-income countries.”

ABC News also reports that the vaccine “can be used in countries with the South African variant” of Covid-19 as well.

“[The] approval endorses that the vaccine can be used to help protect populations across the world, including adults over 65 years and in countries where different variants of [Covid-19] virus are in circulation,” says AstraZeneca CEO Pascal Soriot.

“This is a huge step towards ensuring global access to our vaccine and helping us full our public health commitment to broad and equitable access at no profit during the pandemic.”

Reportedly, the AstraZeneca Covid-19 vaccine can be stored, transported and handled at normal refrigerated conditions for at least six months and administered within existing healthcare settings.

A statement released by AstraZeneca says that the vaccine has been granted conditional marketing authorisation or emergency use in more than 50 countries, with the WHO EUL now accelerating the pathway to access in up to 145 countries through the COVAX Facility.

Doses for Australia

The Australian Government has secured 53.8 million doses of the AstraZeneca vaccine, with 3.8 million doses expected for delivery to Australia in early 2021.

The remaining 50 million doses of the vaccine will be manufactured by CSL in Australia in monthly batches, with the final stages of the manufacturing process planned to commence this week.

As reported by Retail Pharmacy last week, subject to approval by the Therapeutic Goods Administration (TGA), two million doses of the vaccine are expected to be released at the end of March.

This is in addition to the Pfizer Covid-19 vaccine, which, according to various news outlets, arrived in Australia yesterday [15 February 2021].