The World Health Organization has given emergency use approval to one of the Chinese-made Sinopharm’s Covid-19 vaccines in a major boost to the product’s credibility.
The long-awaited decision made on Friday by a WHO technical advisory group would also see the Chinese vaccine being included in the Covax programme for the developing world in the coming weeks, and distributed through UN agencies, potentially benefiting millions of people in need worldwide.
“This afternoon, WHO gave emergency use listing to Sinopharm Beijing’s Covid-19 vaccine,” the WHO director-general, Dr Tedros Adhanom Ghebreyesus, said.
“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.” The Covax programme aims to provide equitable access to doses around the world and particularly in lower-income countries.
The WHO later said in a statement: “On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks. Vaccine efficacy for symptomatic and hospitalised disease was estimated to be 79%, all age groups combined.”
The WHO admitted that few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. Yet, the organisation does not recommend an upper age limit for the vaccine “because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons”, it said.
The WHO has already granted emergency use listing to the vaccines being made by Pfizer/BioNTech, Moderna, Johnson & Johnson, and the Oxford/AstraZeneca jab being produced at sites in India and South Korea.
State-owned Chinese firm, Sinopharm, has so far produced two vaccines – one developed in Beijing, the other made in Wuhan, the city where Covid-19 was first reported last year.
Today’s approval is for the vaccine from Beijing. A decision on a separate Chinese vaccine, Sinovac, is expected next week, WHO said.
Critics of the Chinese-made vaccine had for months questioned what they regarded as a lack of public trial data.
Sinopharm said in March that at least 100m of doses of its two vaccines have been supplied across the world, while over 80m doses of the two vaccines were administered.
Experts said today’s decision by the world’s top public health authority could be a gamechanger, especially for developing countries.
“If there is a green light, these vaccines could boost the thin stream of supplies that has been channelled through Covax to date,” Suerie Moon, co-director of the Global Health Programme at Geneva’s Graduate Institute, told the Associated Press news agency.
Covax – which has pledged to procure two billion doses of jabs by the end of the year – has so far distributed over 54m doses. It is facing limited supplies from western countries and India, where Covid cases continue to rise.