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People wait to receive a dose of the Sinopharm Covid-19 vaccine in Skopje, North Macedonia. Photo: EPA-EFE

Coronavirus: WHO gives emergency approval to China’s Sinopharm vaccine

  • ‘The addition of this vaccine has the potential to rapidly accelerate Covid-19 vaccine access,’ says WHO official
  • The Sinopharm approval comes more than four months after the WHO handed out its first emergency use listing for a Covid-19 vaccine to Pfizer and BioNTech
The World Health Organization (WHO) has approved the first Chinese-made Covid-19 vaccine for emergency use worldwide, as many countries struggle for access in the face of export curbs and production shortfalls.
The WHO on Friday said a Covid-19 vaccine by state-owned Sinopharm met the criteria for emergency use, giving it a globally recognised stamp of approval that will enable it be included in the UN body’s global vaccine distribution programme.
“The addition of this vaccine has the potential to rapidly accelerate Covid-19 vaccine access for countries seeking to protect health workers and populations at risk,” said Dr Mariângela Simão, WHO assistant-director general for access to health products.

“We urge the manufacturer to participate in the Covax Facility and contribute to the goal of more equitable vaccine distribution.”

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Sinopharm said on Saturday that the listing – the first for a product from a “non-Western country” – was a “leap forward” in making vaccines accessible and affordable, especially in developing countries.

“This indicates that the quality, safety, efficacy and accessibility of the vaccine meets the requirements of the WHO and adds Chinese power to fighting the Covid-19 pandemic,” it said.
The green light comes more than four months after the WHO handed out its first emergency use listing for a Covid-19 vaccine to US pharmaceutical company Pfizer and German company BioNTech. Jabs by US companies Johnson & Johnson and Moderna, and British-Swedish firm AstraZeneca have also been given the nod.
China’s pharmaceutical companies have faced intense scrutiny for not releasing detailed data about how well the vaccines work before they came into use. Unlike the other Covid-19 vaccines to win WHO backing, results from the phase 3 clinical trials of the Chinese products have yet to be published in peer-reviewed journals.

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The Sinopharm vaccine was found to be 78 per cent effective in a multi-country phase 3 trial run in coordination with the United Arab Emirates.

A separate assessment from the WHO’s Strategic Advisory Group of Experts on Immunisation (Sage), which met on April 29, had a “high level of confidence” that two doses of the Sinopharm vaccine, made by its subsidiary Beijing Institute of Biological Products, was effective in adults.

But the assessment also highlighted holes in the data collected on the elderly, as only a few hundred people in this group at high-risk for Covid-19 were included in the large-scale final phase trial.

The group had a “low level” of confidence in the quality of evidence about the vaccine efficacy in those over 60, and a “very low level of confidence” in data on the risk of serious adverse events.

Sage does not decide whether the vaccines are licensed, but issues recommendations about their use in different groups.

In its Friday statement, the WHO said the Chinese vaccine would be listed for all adult age groups, based on preliminary data suggesting it was likely to have a protective effect in older adults and no “theoretical reason” to suspect a different level of safety for this group.

Dr Alejandro Cravioto, Sage panel chair, urged countries that used the Chinese vaccine to closely monitor it due to the lack of available data.

“What we are encouraging is for the country or the people in charge of the country programmes to make sure they have strong follow-up programmes of safety and effectiveness of the use of this vaccine,” he said.

“[This was particularly relevant for recipients] aged over 60, for which we have little information, people with comorbidities which are essential as one of the main components of mortality, and the issue of pregnancy for which there is no information for this vaccine,” he said.

“Once we have this information, as with any other vaccine that Sage has reviewed, we will look at the new evidence and make changes in our recommendations for the vaccine.”

US moves won’t solve vaccine access problem for poor soon: experts

Arnaud Didierlaurent, chairman of the WHO’s technical advisory group which recommended the listing, said the assessment of the vaccine had not stopped and that more studies would need to be conducted to provide the missing data.

“We have requested additional studies, which include clinical studies and evidence from the company that committed to perform the studies. We are confident that we will be able to generate the data that the chairman of the Sage mentioned in the future, as soon as possible, to actually allow a continuous evaluation of the vaccine,” he said.

A second Chinese candidate, made by Sinovac, was still undergoing assessment, Didierlaurent said.

“We have started to review the report from Sinovac. We actually requested additional information from the manufacturer … which we hope to receive very soon to make a decision,” he said.

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Sinopharm’s product relies on a traditional vaccine technology, using an inactivated Sars-CoV-2, the virus that causes Covid-19, to provoke an immune response.

Unlike the Pfizer jab, which uses mRNA technology and requires specialised, ultra-cold chain logistics, the Chinese product can be stored and shipped at room temperature, making it more accessible to poorer countries.

With the WHO’s stamp of approval, Sinopharm will now be eligible to be distributed as part of the Covax Facility, a global Covid-19 vaccine distribution scheme that has struggled to deliver on its goal of ensuring equitable vaccine access for low- to middle-income countries.

Senior WHO adviser Bruce Aylward said the WHO was interested in Sinopharm’s capability to help with the global response while meeting domestic demand.

“What we are particularly interested in Sinopharm is what they may be able to do beyond China to help with the global response and there’s been a lot of work by the company over the last few months to move from lower double-digit numbers into the higher three-digit numbers to help with the global response,” he said.

“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.”

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The Covax scheme has been crippled by vaccine export curbs from India, as the country deals with a spiralling Covid-19 health crisis.

It has so far delivered about 54 million doses out of the 238 million that were promised to about 140 countries by the end of this month, placing more demand on Chinese vaccines, which have already been approved for emergency use in dozens in countries.

Populous nations including Brazil, Indonesia and Pakistan have rolled out doses by Chinese companies. The other Chinese companies include Sinovac Biotech and CanSino Biologics.

In Europe, production shortfalls have led to long delays in vaccine roll-out plans. On January 29, Hungary ordered 5 million doses of the Sinopharm vaccine. It became the first European Union member to unilaterally approve a Chinese-made vaccine for emergency use.

The vaccine’s approval by the WHO is expected to bolster global confidence in the vaccines, while its inclusion in Covax could boost the dose-strapped mechanism.

So far no supply deals have yet been announced with Chinese vaccine makers. Beijing earlier said it planned to donate 10 million doses to the facility.

This article appeared in the South China Morning Post print edition as: WHO grants emergency approval for first Chinese vaccine
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