Sinovac says its coronavirus vaccine candidate appears safe for elderly in early trials

Chinese firm Sinovac Biotech Ltd. said on Monday 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 for younger adults.

Health officials have been concerned about whether experimental vaccines could safely protect the elderly, whose immune systems usually react less robustly to vaccines, against the virus that has led to nearly 890,000 deaths worldwide.

Sinovac’s candidate CoronaVac did not cause severe side effects in combined Phase 1 and Phase 2 trials launched in May involving 421 participants aged at least 60, Liu Peicheng, Sinovac’s media representative, told Reuters. The complete results have not been published and were not made available to Reuters.

The World Health Organization is working with China on requirements for international approval of any Chinese COVID-19 vaccine, a senior official said on Monday.

“WHO’s office in China and WHO headquarters has been working with the regulatory authorities in China,” assistant director-general Mariangela Simao told a briefing in Geneva. “We are in direct contact. We have been sharing information and the requirements for international approval of vaccines.”

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

For three groups of participants who respectively took two shots of low, medium and high-dose CoronaVac, over 90 per cent of them experienced significant increase in antibody levels, while the levels were slightly lower than those seen in younger subjects but in line with expectation, Liu said in a statement.

CoronaVac, being tested in Brazil and Indonesia in the final-stage human trials to evaluate whether it is effective and safe 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 to protect people facing high infection risk.

The potential vaccine could remain stable for up to three years in storage, Liu said, which might offer Sinovac some advantage in vaccine distribution to regions where cold-chain storage is not an option. Cold-chain refers to the process used to maintain optimal conditions during the transport, storage and handling of vaccines, according to the Public Health Agency of Canada.

Such estimation is extrapolated from the fact that vaccines readings stayed within acceptable ranges for 42 days at 25 C, 28 days at 37 C and five months for 2-8 C, Liu said, without disclosing complete data.

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