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WHO grants emergency use listing for AZ/Oxford University’s COVID-19 vaccine

The emergency use listing authorises the use of the vaccine in all adults, including over-65s

The World Health Organization (WHO) has given AstraZeneca (AZ) and Oxford University’s COVID-19 vaccine an emergency use listing (EUL) for all adults.

The formal EUL follows a recommendation from the WHO’s Strategic Advisory Group of Experts (Sage) last week that backed the use of the vaccine in adults, including those aged over 65.

The EUL covers the use of the AZ/Oxford vaccine in a two-dose regimen, to be administered at a four- to 12-week interval.

This dosing interval was recommend by the WHO’s Sage, which also recommended the use of the vaccine in countries with high levels of new variants – including the South African B1.351 variant.

“[The WHO] 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 the SARS-CoV-2 virus are in circulation,” said Pascal Soriot, chief executive officer of AZ.

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

In June 2020, the Serum Institute of India signed a licensing deal with AZ to provide one billion doses of the Oxford-partnered vaccine to low- and middle-income countries.

Following the WHO’s EUL, the Serum Institute and AZ will begin to work with the international vaccine-sharing facility COVAX to begin supplying the vaccine globally.

The majority of these supplies will be delivered to low- and middle-income countries ‘as quickly as possible’.

AZ said in a statement that it expects over 300 million doss of the vaccine to be made available to 145 countries through COVAX in the first half of 2021.

It is hoped that the distribution of the AZ/Oxford vaccine will allow for the rapid delivery of doses, as the jab can be stored, transported and handled at normal refrigerated conditions (+2°-+8° C) for at least six months.

“We have been waiting for this final milestone. I am happy and relieved that with the WHO's EUL we will be able to start the deliveries to African and other low- and middle-income countries immediately. Countries with a large population must be protected as soon as possible,” said Adar Poonawalla, chief executive officer, Serum Institute of India.

Article by
Lucy Parsons

16th February 2021

From: Regulatory



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