WHO gives emergency approval to Sinopharm, first Chinese COVID-19 vaccine

WHO gives emergency approval to Sinopharm, first Chinese COVID-19 vaccine

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A general practitioner opens a packet containing vials of China's Sinopharm COVID-19 vaccine on Mar 25, 2021. (Photo: AP/MTI/Attila Balazs)

GENEVA: The World Health Organization announced on Friday (May 7) it had approved a COVID-19 vaccine from China's state-owned drugmaker Sinopharm for emergency use.

The vaccine, one of two main Chinese shots that collectively have already been given to hundreds of millions of people in China and abroad, becomes the first COVID-19 shot developed by a non-Western country to win the WHO's backing.

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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.

"This afternoon, WHO gave emergency use listing to Sinopharm Beijing's COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality," the UN health agency's director-general Tedros Adhanom Ghebreyesus told a news conference.

Tedros also said that a separate expert panel has recommended two doses of Sinopharm vaccine for those aged 18 and above. 

The WHO has previously given emergency approval to COVID-19 vaccines developed by Pfizer-BioNTech, AstraZeneca, Johnson & Johnson, and, last week, Moderna.

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The decision to approve Sinopharm's vaccine was taken by WHO's technical advisory group, which began meeting on Apr 26 to review the latest clinical data as well as Sinopharm's manufacturing practices.

A separate group of WHO experts, the Strategic Advisory Group of Experts (SAGE), voiced concern this week over data provided by Sinopharm on the risk of serious side-effects in some patients, but was confident in the vaccine's ability to prevent disease, according to a document reviewed by Reuters.

SAGE found an efficacy of 78.1 per cent after two doses in multi-country Phase III clinical trials, according to the document. The vaccine's developer, Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group, had announced an efficacy of 79.34 per cent.

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The WHO has said it could reach a decision on China's other main COVID-19 vaccine, made by Sinovac Biotech, as soon as next week. The technical experts reviewed it on Wednesday.

China has deployed around 65 million doses of the Sinopharm vaccine and more than 200 million doses of the Sinovac shot. Both have been exported to many countries, particularly in Latin America, Asia and Africa, many of which have had difficulty securing supplies of vaccines developed in the West.

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Source: Agencies/zl

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