WHO’s Emergency Use Listing, granted to AstraZeneca and Serum Institute of India, will provide global access to the vaccine
The World Health Organization (WHO) has granted Emergency Use Listing (EUL) for two versions of the AstraZeneca’s Covid-19 vaccine, in people aged 18 years and older, including those above 65 years.
The two vaccines include AstraZeneca Covid-19 vaccine manufactured by AstraZeneca and COVISHIELD manufactured by Serum Institute of India (SII), administered in two doses.
WHO said that its EUL evaluates the quality, safety and efficacy of Covid-19 vaccines and is a criterion for COVAX Facility to supply the vaccine.
Also, the listing would enable countries to advance their individual regulatory approval to import and administer Covid-19 vaccines.
WHO assistant director-general for access to medicines and health products Mariângela Simão said: “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.
“But we must keep up the pressure to meet the needs of priority populations everywhere and facilitate global access. To do that, we need two things – a scale-up of manufacturing capacity, and developers’ early submission of their vaccines for WHO review.”
According to the clinical trials, the vaccine regimen is safe and effective in preventing symptomatic Covid-19, with no severe cases and no hospitalisations, more than 14 days post-second dose vaccination.
The WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) recommended a dosing interval of eight to 12 weeks.
Also, SAGE recommended the use of the vaccine in countries where new variants, including the South African B1.351 variant, are prevalent.
AstraZeneca and SII are planning to work with the COVAX Facility to commence the vaccine supply, with the majority going to low and middle-income countries as quickly as possible.
AstraZeneca chief executive officer Pascal Soriot said: “Today’s 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.”
Serum Institute of India chief executive officer Adar Poonawalla said: “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.”