The World Health Organisation approved for emergency use a COVID-19 vaccine from China's state-owned drug maker Sinopharm, bolstering Beijing's push for a bigger role in inoculating the world.
The vaccine, one of two main Chinese coronavirus vaccines that have been given to hundreds of millions of people in China and elsewhere, is the first developed by a non-Western country to win WHO backing.
It is also the first time the WHO has given emergency use approval to a Chinese vaccine for any infectious disease. Earlier this week, separate WHO experts had expressed concern about the quality of data the company provided on side effects.
A WHO emergency listing is a signal to national regulators that a product is safe and effective. It also allows it to be included in COVAX, a global program to provide vaccines mainly for poor countries, which has hit supply problems.
"This expands the list of COVID-19 vaccines that COVAX can buy, and gives countries confidence to expedite their own regulatory approval, and to import and administer a vaccine," WHO director-general Tedros Adhanom Ghebreyesus told a briefing on Friday.
Senior WHO adviser Bruce Aylward said it would be up to Sinopharm to say how many doses of its vaccine it could provide to the program, but added: "They are looking at trying to provide substantial support, make substantial doses available while at the same time of course trying to serve China's population."
The WHO had already given emergency approval to COVID-19 vaccines developed by Pfizer-BioNTech, AstraZeneca, Johnson & Johnson and, last week, Moderna.
"This ... signifies that the quality, safety, efficacy and accessibility of Sinopharm CNBG's COVID-19 vaccine meet the requirements of WHO standards, which will contribute more Chinese power to the global fight against the COVID-19 pandemic," Sinopharm said in a social media statement on Saturday.
The decision to approve Sinopharm's vaccine was taken by WHO's technical advisory group. "Its easy storage requirements make it highly suitable for low-resource settings," a WHO statement said.
Tedros said that, following the approval, its separate Strategic Advisory Group of Experts had recommended that adults over 18 receive two doses of the Sinopharm vaccine.
The vaccine, developed by Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group, has an estimated efficacy of 79 per cent for all age groups, the WHO said in a statement.
Alejandro Craviato, SAGE panel chair, said: "The information we have for people over 60 is still very scarce. There is no reason to think the vaccine would behave differently in this older age group."
But noting gaps in clinical data, he said that Sinopharm or national authorities should monitor people over 60, those with co-morbidities and pregnant women after vaccination.
The WHO has said it could reach a decision on China's other main COVID-19 vaccine, made by Sinovac Biotech, next week. The technical experts reviewed it on Wednesday.
Australian Associated Press