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GENEVA / BEIJING (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 (September 7).
“The WHO China office and WHO headquarters have been working with the regulatory authorities in China,” said Deputy Director General Mariangela Simao at a briefing in Geneva. “We are in direct contact, we have been sharing information and the requirements for the international approval of vaccines.”
Chinese firm Sinovac Biotech Ltd said on Monday that its coronavirus vaccine candidate appeared to be safe for older people, based on preliminary results from an early to mid-stage trial, while immune responses triggered by the vaccine were slightly higher. weaker than those of younger adults.
Health officials have been concerned about whether experimental vaccines could safely protect the elderly, whose immune systems generally react less strongly to vaccines, against the virus that has caused nearly 890,000 deaths worldwide.
Sinovac’s CoronaVac candidate did not cause serious side effects in the combined Phase 1 and Phase 2 trials launched in May with 421 participants aged at least 60 years, Liu Peicheng, a media representative for Sinovac, told Reuters.
The full results have not been published and were not made available to Reuters.
Four of the eight vaccines in the world that are in the third phase of trials are from China.
For three groups of participants who took two low, medium and high dose CoronaVac injections respectively, more than 90% of them experienced a significant increase in antibody levels, while the levels were slightly lower than those seen in older subjects. young but in line with expectations. Liu said in a statement.
CoronaVac, which is being tested in Brazil and Indonesia in end-stage human trials to assess whether it is effective and safe enough to gain regulatory approvals for mass use, has already been awarded to tens of thousands of people, including about 90 % of Sinovac employees. and their families as part of China’s emergency vaccination plan to protect people at high risk of infection.
The scope of vaccines under the emergency program, which China launched in July but has released few details about, indicates how actively it is using experimental vaccines in hopes of protecting essential workers against a possible resurgence of Covid- 19, even when trials are still in progress. on going.
The potential vaccine could remain stable for up to three years in storage, Liu said, which could offer Sinovac some advantage in distributing vaccines to regions where cold chain storage is not an option.
Such an estimate is extrapolated from the fact that the vaccine readings remained within acceptable ranges for 42 days at 25 degrees Celsius, 28 days at 37 ° C (98.6 F), and five months at 2-8 ° C (35 , 6-46.4 F), Liu said, without disclosing complete data.
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