GENEVA • The World Health Organisation (WHO) has listed AstraZeneca and Oxford University’s Covid-19 vaccine for emergency use, widening access to the relatively inexpensive shot in the developing world.
“We now have all the pieces in place for the rapid distribution of vaccines. But we still need to scale up production,” WHO director-general Tedros Adhanom Ghebreyesus told a news briefing on Monday.
“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.”
A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (South Korea) and the Serum Institute of India (SII).
British drugmaker AstraZeneca said in a separate statement announcing the approval: “In the first half of 2021, it is hoped that more than 300 million doses of the vaccine will be made available to 145 countries through Covax, pending supply and operational challenges.”
The listing by the United Nations health agency comes days after a WHO panel provided interim recommendations on the vaccine, saying two doses with an interval of around eight to 12 weeks should be given to all adults, and can also be used in countries with the South African variant of the coronavirus.
The WHO’s review found that the AstraZeneca vaccine met the “must-have” criteria for safety, and its efficacy benefits outweighed its risks.
The vaccine has been hailed because it is cheaper and easier to distribute than some of its rivals.
Nearly 109 million people globally have been reported to be infected by the coronavirus and more than 2.5 million have died, according to a Reuters tally.
AstraZeneca’s vaccine makes up the lion’s share of doses in the Covax coronavirus vaccine-sharing initiative, with more than 330 million doses of the shot due to be rolled out to poorer countries from the end of this month.
WHO established its emergency-use listing process to help poorer countries without their own regulatory resources quickly approve medicines for new diseases like Covid-19, which otherwise could lead to delays.
The Covax Facility, which is co-led by the Gavi vaccine alliance, WHO, the Coalition for Epidemic Preparedness Innovations and the UN Children’s Fund, has said doses would cover an average of 3.3 per cent of total populations of 145 participating countries.
The British drug regulator is also auditing manufacturing processes at SII, which could pave the way for AstraZeneca’s vaccine to be shipped from there to Britain and other countries, according to two sources close to the matter.
SII, the world’s largest vaccine manufacturer, is mass producing the AstraZeneca vaccine for dozens of poor and middle-income countries but not Britain, which has been getting its supply of the shot primarily from domestic facilities.
Meanwhile, Australia’s medical regulator said yesterday that it had granted provisional approval for the AstraZeneca vaccine, making it the second vaccine to get regulatory approval in Australia.
The Pfizer-BioNTech vaccine was approved last month for use and inoculations for the country’s 25 million population will begin next Monday.