China’s Sinopharm becomes first non-Western vaccine to win WHO approval
London: The World Health Organisation has made its long-awaited decision on China’s Sinopharm COVID-19 vaccine, approving the jab for emergency use in all adults, meaning it can be rolled out globally.
The WHO said that based on the available data, the vaccine was 79 per cent effective against symptomatic and hospitalised cases of the disease for all ages. Clinical trials run by the state-owned company Sinopharm also showed that it had an efficacy rate of 79 per cent.
WHO is recommending the vaccine, which has been used on millions of people around the world, for those aged 18 and over on a two-dose regimen with a spacing of three to four weeks between them.
The vaccine, officially named BBIBP-CorV, is in use in China, Egypt, United Arab Emirates, Pakistan and Bangladesh among other countries. It is different to the Chinese-developed CoronaVac used in Indonesia and Brazil, among others.
The emergency-used listing is a major coup for China. Sinopharm is the first non-Western vaccine to win WHO backing and sit alongside those produced by Pfizer/BioNTech, AstraZeneca/Oxford, Johnson & Johnson (Janssen) and Moderna.
It uses inactivated vaccine technology, the same type used for polio, rabies and hepatitis A vaccines, where dead virus particles are mixed with an adjuvant which boosts immune response.
RELATED ARTICLE
WHO Director-General Tedros Adhanom Ghebreyesus said the approval had the potential to accelerate to vaccines access through the UN-backed COVAX scheme for low-income countries.
“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,” he told a virtual news conference.
Earlier this year, Sinopharm’s chairman Liu Jingzhen told Chinese state media that production had reached nearly 100 million doses by the end of 2020. He said more than 1 billion doses were expected to be produced in 2021.
“At present, we plan to further expand capacity in order to better meet demand,” Lui said.
The vaccine can be transported at temperatures between 2 and 8 degrees which the WHO said made it “highly suitable for low-resource settings”.
It will be the first vaccine to carry vaccine vial monitors - small stickers that will change colour if exposed to heat.
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.
In its statement approving the product for emergency use, WHO said the vaccine’s efficacy could not be estimated for older adults, as few aged over 60 had participated in trials.
But it said preliminary data and supportive immunogenicity data suggested the vaccine was “likely to have a protective effect” in older persons.
“There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations,” the organisation said.
“WHO therefore recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust.”
The WHO said part of its processes in granting the approval included on-site inspection visits of the Chinese production facilities.
