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WHO approves emergency use of China's Sinopharm vaccine

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A medical staff prepares a dose of the Chinese Sinopharm COVID-19 vaccine as part of a mass vaccination campaign at the Boris Trajkovski Arena in Skopje, North Macedonia, May 6. AFP-Yonhap
A medical staff prepares a dose of the Chinese Sinopharm COVID-19 vaccine as part of a mass vaccination campaign at the Boris Trajkovski Arena in Skopje, North Macedonia, May 6. AFP-Yonhap

The World Health Organization (WHO) approved a COVID-19 vaccine from China's state-owned drug maker Sinopharm for emergency use Friday, a boost to Beijing's push for a big role in inoculating the world.

The vaccine, one of two main coronavirus vaccines from China that have been given to hundreds of millions of people there 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, however, separate WHO experts expressed concern about the quality of data provided by the company 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.

Senior WHO adviser Bruce Aylward said it would be up to Sinopharm to say how many doses of its vaccine it can 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 has already given emergency approval to vaccines developed by Pfizer-BioNTech, AstraZeneca, Johnson & Johnson and, last week, Moderna.

World Health Organization Director-General (WHO) Tedros Adhanom Ghebreyesus attends a news conference organized by Geneva Association of United Nations Correspondents amid the COVID-19 pandemic at the WHO headquarters in Geneva, Switzerland, July 3, 2020. The WHO approved a COVID-19 vaccine from China's state-owned drug maker Sinopharm for emergency use Friday, Reuters-Yonhap
World Health Organization Director-General (WHO) Tedros Adhanom Ghebreyesus attends a news conference organized by Geneva Association of United Nations Correspondents amid the COVID-19 pandemic at the WHO headquarters in Geneva, Switzerland, July 3, 2020. The WHO approved a COVID-19 vaccine from China's state-owned drug maker Sinopharm for emergency use Friday, Reuters-Yonhap

'Easy storage'

The decision to approve Sinopharm's vaccine was taken by the WHO's technical advisory group, which since April 26 has reviewed the company's latest clinical data and manufacturing practices.

"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 (SAGE) had recommended that adults over 18 receive two doses of the Sinopharm vaccine.

"On the basis of all available evidence, the WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks," the WHO statement said.

The vaccine, developed by Beijing Biological Products Institute, a unit of the Sinopharm subsidiary of the China National Biotec Group, has an estimated efficacy of 79% for all age groups, it said.

Alejandro Craviato, SAGE panel chairman, 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 may reach a decision on China's other main COVID-19 vaccine, made by Sinovac Biotech, next week. Technical experts reviewed it Wednesday.

Arnaud Didierlaurent, chairman of the WHO's technical advisory group, told the news conference: "We have started to review the report from Sinovac. We actually requested additional information to the manufacturer ... which we hope to receive very soon to make a decision."

China has deployed around 65 million doses of the Sinopharm vaccine and some 260 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. (Reuters)




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