The World Health Organization (WHO) has approved a Covid-19 vaccine from China's state-owned pharmaceutical company, Sinopharm, for emergency use, laying a path for the jab to be used in poorer nations via the Covax scheme.
The vaccine, one of two main Chinese shots that collectively have already been given to hundreds of millions of people in China and abroad, is the first Covid-19 jab developed by a non-Western country to win the WHO’s backing.
It is also the first time the WHO has given emergency use approval to any Chinese vaccine for any infectious disease.
A WHO emergency listing is a signal to national regulators on a product’s safety and efficacy, and would allow the shot to be included in Covax, the global programme to provide vaccines mainly for poor countries, which global health experts described as a “game changer”.
Dr Tedros Adhanom Ghebreyesus, WHO chief, told a press conference: “This afternoon, WHO gave [an] emergency use listing to Sinopharm Beijing’s Covid-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality.
“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.”
Dr Tedros added that the WHO’s Sage committee of experts had reviewed the data and recommended adults over 18 have the jab with a two dose schedule. The team said there was limited evidence on the jab for the over-60s, but added that there was no reason to expect it to perform differently in this age group.
The Sinopharm jab is an inactivated whole virus vaccine, and achieved 79 per cent efficacy in clinical trials, although experts have asked for more public detail on the studies for scientists to independently assess.
It is easier to store and transport than some of the other jabs, including Pfizer and Moderna, as it can be kept in normal fridges. It is also the first vaccine to carry a vial monitor, a sticker that will change colour if the vials are exposed to heat.
Unlike in Western countries, China began administering the jab to frontline health workers back in July, before trials concluded. Other countries, like Bahrain and the United Arab Emirates, also started using the jab in December. China granted it approval for use among the public on 31 December.
WHO is also considering the other Chinese jab, Sinovac, for approval in the next few weeks.
Andrea Taylor, a vaccine data analyst at the Duke Global Health Institute, told The New York Times the Chinese jabs could be a “game changer”.
“The situation right now is just so desperate for low- and lower-middle-income countries that any doses we can get out are worth mobilising,” she said. “Having potentially two options coming from China could really change the landscape of what’s possible over the next few months.”
The decision could be a boon for Chinese vaccine diplomacy efforts, as the country seeks to capitalise on unequal vaccine rollout by filling the gaping holes in global distribution, largely triggered by decisions in the West to prioritise domestic rollout.
Yet some commentators have warned that a wave of new vaccines for lower income countries may take some time to materialise as, despite claims from China that it will manufacture some five million vaccines by the end of 2021, the country is struggling to ramp up production.
It is also unclear how many doses of the Sinopharm vaccine may be available for Covax, though Gavi, the Vaccine Alliance - a co-founder of the initiative - said negotiations are ongoing.
“We welcome today's news that Sinopharm has been granted WHO Emergency Use Listing, as this means the world has yet another safe and effective tool in the fight against this pandemic,” a spokesperson told The Telegraph.
“Gavi, on behalf of the Covax Facility, is in dialogue with several manufacturers, including Sinopharm, to expand and diversify the portfolio further and secure access to additional doses for Facility participants.”
The People's Vaccine Alliance, a campaign group including organisations like Oxfam and Amnesty which has been pushing for companies to waive patents and share vaccine technology, said the announcement was great news for lower income nations.
“This is great news for people in developing countries who, for months, have been watching people in rich countries being vaccinated while they have been left at the back of the queue,” said Dr Mohga Kamal Yanni, a health policy expert for the group.
“We call on Sinopharm to make the price affordable to countries and to Covax and urge them to expand production and share their technology.”
The WHO has previously given emergency approval to Covid-19 vaccines developed by Pfizer-BioNTech, AstraZeneca, Johnson & Johnson, and, last week, Moderna.
Protect yourself and your family by learning more about Global Health Security