WHO, China working together on vaccine approval

GENEVA/BEIJING • The World Health Organisation (WHO) is working with China on requirements for international approval of any Chinese Covid-19 vaccine, a senior WHO official has said.

"WHO's office in China and WHO headquarters have been working with the regulatory authorities in China," assistant director-general Mariangela Simao said on Monday.

"We are in direct contact, we have been sharing information and the requirements for international approval of vaccines."

Chinese firm Sinovac Biotech said on Monday that its coronavirus vaccine candidate appeared to be safe for older people, according to preliminary results from an early to mid-stage trial, while the immune responses triggered by the vaccine were slightly weaker than those in younger adults.

Health officials have been concerned about whether experimental vaccines can protect the elderly, whose immune systems react less robustly to vaccines.

Sinovac's candidate CoronaVac did not cause severe side effects in combined phases one and two trials launched in May involving 421 people aged at least 60, Sinovac's media representative Liu Peicheng said. The complete results have not been published.

Four of the world's eight vaccines that are in the third phase of trials are from China.

For three groups of people who respectively took two shots of low, medium and high-dose CoronaVac, more than 90 per cent of them saw significant increases in antibody levels, Mr Liu said. The levels were slightly lower than those seen in younger subjects but in line with expectations, he added.

CoronaVac - which is in final-stage human trials in Brazil and India to evaluate if it is safe and effective enough to obtain regulatory approvals for mass use - has already been given to tens of thousands of people, including about 90 per cent of Sinovac employees and their families, as part of China's emergency inoculation scheme.

The extent of inoculations under the programme, which China launched in July, points to how actively it is using experimental vaccines in the hopes of protecting its essential workers even as trials are still under way.

Mr Liu said the potential vaccine could remain stable for up to three years in storage, which may offer Sinovac an advantage in vaccine distribution to regions where cold-chain storage is not an option.

Meanwhile, the WHO is in talks with India about joining the Covax global vaccine allocation plan.

"India is certainly eligible, like all countries in the world, to be part of the Covax facility and discussions are ongoing in that regard," Dr Bruce Aylward said on Monday. "We would welcome Indian participation... India has extensive experience (with vaccines)."

The WHO and the Gavi vaccine alliance are leading the Covax facility, aimed at helping to buy and fairly distribute vaccination shots against Covid-19 worldwide. But some countries, like the US, that have secured their own supplies through bilateral deals have said they will not join Covax.

REUTERS