WHO grants emergency approval for first Chinese vaccine
UN body gives nod to Sinopharm jab, the only non-Western one on its list
The World Health Organization has approved the first Chinesemade vaccine for emergency use worldwide, as many countries struggle for access amid export curbs and production shortfalls.
The WHO said a coronavirus 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 United Nation body’s global 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, a WHO assistant director general.
Sinopharm said yesterday 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 coronavirus vaccine to US pharmaceutical company Pfizer and German company BioNTech. Jabs by United States companies Johnson & Johnson and Moderna, and British-Swedish firm AstraZeneca have also been given the nod.
China’s drug companies have faced scrutiny for not releasing detailed data about how well the vaccines work before they came into use. Unlike the other vaccines to win WHO backing, results from phase 3 clinical trials of Chinese products have yet to be published in peer-reviewed journals.
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, were 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 vaccines are licensed, but does issues recommendations.
In its statement on Friday, 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 doubt safety for this group would differ from other adults.
Dr Alejandro Cravioto, Sage panel chair, urged countries that used the vaccine to monitor it.
“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 on the 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.
Arnaud Didierlaurent, chairman of the WHO’s technical advisory group, which recommended the listing, said the assessment of the vaccine had not stopped.
“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 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.
Sinopharm’s product relies on a traditional vaccine technology, using an inactivated Sars-CoV-2, virus – which causes Covid-19 – to provoke an immune response.
Unlike the Pfizer jab, which uses mRNA technology and requires ultra-cold storage, the Chinese one can be used at room temperature, making it more accessible to poorer countries.
With the WHO’s approval, Sinopharm will now be eligible to be part of the Covax Facility, a global distribution scheme that has struggled to deliver on its goal of ensuring equitable vaccine access for poorer countries. No such agreement with the company has yet been made public.