It is the second COVID-19 vaccine to receive the WHO’s EUL, after Pfizer was the first to be listed in December.
The WHO authorization for the AstraZeneca vaccine covers two applications: one for the vaccine known as ‘COVID-19 Vaccine AstraZeneca’ manufactured by AstraZeneca, and ‘COVISHIELD’ manufactured by Serum Institute of India (SII). The EUL is for people aged 18 years and older, including those over 65.
The EUL allows for two doses of the vaccine to be administered at a four to 12-week interval. The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) has recommended use of the vaccine in countries where new variants, including the South African B1.351 variant, are prevalent.
The authorization was based on pooled analysis for efficacy from 11,636 participants aged 18+, accruing 131 symptomatic COVID-19 infections from the UK and Brazil Phase III trials. Overall safety was based on an interim analysis of pooled data from four clinical trials conducted in the UK, Brazil and South Africa which included 23,745 participants aged 18+.
Initial distribution of 300 million doses for COVAX
AstraZeneca’s COVID-19 vaccine has been given the green light in more than 50 countries. The WHO EUL will now serve to accelerate the pathway to access in up to 145 countries through the COVAX Facility.
In the first half of 2021, AstraZeneca and SII hope to make more than 300 million doses of the vaccine available to COVAX, with the majority going to low and middle income countries, pending supply and operational challenges. These doses will be allocated equitably according to the COVAX Allocation Framework.
Pascal Soriot, Chief Executive Officer, said: “This 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. This is a huge step towards ensuring global access to our vaccine and helping us fulfil our public health commitment to broad and equitable access at no profit during the pandemic.”
In June 2020, AstraZeneca announced a sub-licencing agreement with the SII to manufacture and supply up to one billion doses of the vaccine to low and middle-income countries. The SII says it will now be able to start the deliveries to African and other low and middle-income countries immediately.
AstraZeneca was the first global pharmaceutical company to join COVAX in June 2020. Its vaccine can be stored, transported and handled at normal refrigerated conditions (two-eight degrees Celsius/36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings, making it better suited to distribution in countries with limited infrastructure than other vaccines which require freezer or ultra-low storage.
