WHO: Emergency approve use of China's Covid-19 Sinopharm vaccine

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The vaccine, one of two main Chinese coronavirus vaccines that have been given to hundreds of millions of people in China and elsewhere, is the first developed by a non-Western country to win WHO backing.

Sinopharm’s jab is the first vaccine of any kind made in China to receive emergency use authorisation from the WHO © AFP via Getty Images

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, according to Reuters.

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 programme 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 programme, 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.”

Photo: Reuters

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 Sinopharm’s vaccine was taken by WHO’s technical advisory group, which met since April 26 to review the 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, 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 said in a statement.

‘Very confident’

Previously, a separate group advising WHO on vaccines said it was “very confident” the Sinopharm vaccine protects people aged 18-59.

Photo: Getty Images

The group said it had a “low level of confidence” in the vaccine’s efficacy for people 60 and over, Al Jazeera reported.

Its members said they had “very low confidence” in the available data about serious side effects in that age group.

Sinopharm has not published its late-stage test results in scientific journals, so the WHO requested a breakdown of its data, which come mostly from the United Arab Emirates.

A summary posted online by WHO suggests the vaccine is about 78 percent effective, with the caveat that all but a few hundred of the study volunteers were younger than 60.

Gavi, the Vaccine Alliance, which co-runs COVAX, welcomed WHO’s approval of emergency use.

“This means the world has yet another safe and effective tool in the fight against this pandemic,” the alliance said.

The public-private partnership said it was in discussions with several manufacturers, including Sinopharm, “to expand and diversify the portfolio further and secure access to additional doses” for countries in the COVAX programme.

COVAX aims to send vaccines for free to 92 lower-income countries and to help another 99 countries and territories procure them.

It was not immediately clear when the Chinese vaccine might be made available to the COVAX portfolio.

Arnaud Didierlaurent, chair of WHO’s technical advisory group, told the press 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.”

Sinopharm, which has two Covid-19 vaccines approved in China, has supplied over 200 million doses at home and abroad, and Sinovac has shipped over 300 million doses of its shot worldwide, including at home. Both companies' vaccines 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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