WHO gives emergency approval to China’s first COVID-19 vaccine, Sinopharm


GENEVA (Reuters) – The World Health Organization (WHO) on Friday approved a COVID-19 vaccine from Chinese state-run pharmaceutical company Sinopharm for emergency use, a boost to Beijing’s drive to play a major role in the inoculation of the world.

The vaccine, one of the two major vaccines against Chinese coronavirus that has been given to hundreds of millions of people in China and elsewhere, is the first developed by a non-Western country to get WHO support.

It is also the first time the WHO has given emergency approval to a Chinese vaccine for any infectious disease. Earlier this week, separate WHO experts had expressed concern about the quality of the data the company provided 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 to poor countries, which has suffered supply problems.

“This expands the list of COVID-19 vaccines that COVAX can buy and gives countries confidence to accelerate their own regulatory approval and to import and administer a vaccine,” said WHO Director-General Tedros Adhanom Ghebreyesus.

WHO senior adviser Bruce Aylward said it was up to Sinopharm to say how many doses of its vaccine it could provide to the program, but added: “They are looking to provide substantial support, making substantial doses available at the same time. trying, of course, to serve the Chinese people. “

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

The decision to approve the Sinopharm vaccine was made by the WHO technical advisory group, which began meeting on April 26 to review Sinopharm’s latest clinical data and manufacturing practices.

“Its easy storage requirements make it very suitable for low-resource configurations,” a WHO statement said.

Tedros said that after approval, his group of strategic advisory experts (SAGE) had recommended that adults over the age of 18 receive two doses of the Sinopharm vaccine.

“Based on all available evidence, the WHO recommends the vaccine for adults 18 years of age or older, in a two-dose program spaced three to four weeks apart,” the WHO statement said.

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

However, he added: “Few older adults (over 60) enrolled in clinical trials, so efficacy could not be estimated in this age group.”

The WHO has said it could reach a decision on China’s other main COVID-19 vaccine, taken by Sinovac Biotech, next week. Technical experts reviewed it on Wednesday.

Arnaud Didierlaurent, chairman of the WHO technical advisory group, told the press conference: “We have started reviewing the Sinovac report. In fact, we asked the manufacturer for additional information … which we hope to receive very much soon to make a decision “.

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

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