China’s Sinopharm, Sinovac Covid-19 vaccines assessed by WHO for emergency use

(SCMP) – Coronavirus vaccines developed by Chinese firms Sinovac and Sinopharm are being reviewed for emergency use by the World Health Organization, potentially opening the door to their increased international acceptance.

The UN agency is also in contact with another Chinese vaccine developer, CanSino, whose jab is undergoing phase 3 trials, it said.

The WHO’s advisory group makes recommendations about whether, how and for whom vaccines should be used. Its “emergency use listing” procedure allows unlicensed vaccines and treatments to be assessed to potentially expedite their approval by individual countries or jurisdictions in public health emergencies.

A decision on the Chinese vaccines was not expected until March at the earliest, the agency said.

“For Sinovac and Sinopharm, the [emergency use listing] process is proceeding,” Katherine O’Brien, director of the WHO’s immunisation and vaccines department, said in a video press conference on Tuesday. “They’ve submitted the package of data and that data is being reviewed.”

A team sent to China to evaluate the firms’ manufacturing facilities was still in quarantine, she said.

“Submission of the data is the critical component,” she said. “We can’t, of course, undertake any policy recommendation without having full access to the data.”

The global health body said it would “assess the quality, safety and efficacy data generated during development and conduct a risk-benefit assessment to decide if they can be used outside clinical trials”.

The process helps WHO member states and UN procurement agencies to determine the acceptability of vaccines.

Vaccines which are proven to be safe and effective can be considered for Covax, the WHO-led initiative for fair distribution of inoculations, according to Seth Berkley, chief executive of Gavi, the Vaccine Alliance – the public-private global partnership that co-leads Covax.

Asked about Chinese and Russian vaccines, he told a WHO press conference on Saturday: “We will consider any vaccines for inclusion in Covax assuming they add value to the portfolio, assuming that there is transparent data on safety and efficacy and that we can come up with a reasonable price point and supply allocation that makes sense.”

China has given nearly 23 million doses of Covid-19 vaccines, according to the latest figures from the National Health Commission. The country launched its mass vaccination campaign this month as it grapples with fresh coronavirus outbreaks. China reported 75 new Covid-19 cases on Wednesday.

It aims to have 50 million people immunised before the Lunar New Year holiday in mid-February, when an estimated 1.7 billion trips are expected to be made as people cross the country to see relatives – about 40 per cent fewer than usual after the authorities urged people not to travel.

China’s vaccinations have prioritised immigration staff, international and domestic transport workers, health care workers and public service providers. Plans are afoot to inoculate children and the elderly.

The National Health Commission said it has asked local authorities to monitor, report and treat adverse reactions after inoculation.

WHO documents showed that the Sinopharm vaccine was in the process of being assessed, while Sinovac submitted data in the middle of January and its dossiers of product information are expected to reach the WHO by the end of the month.

The vaccine developed by state-owned Sinopharm became the first to be approved in China when authorities gave approval with conditions for its market launch on December 31. The vaccine had been shown to be safe and 79 per cent effective in preventing Covid-19, according to an interim analysis announced by the company.

Final-phase trial data for the Sinovac vaccine has been released in a confusing and piecemeal fashion. In mid-January, the Brazilian research institute that conducted the phase 3 clinical trials said it had an efficacy rate of 50 per cent.