WHO validates China's Sinovac COVID-19 vaccine for emergency use

"I am happy to announce that the Sinovac coronavirus vaccine has been given WHO Emergency Use Listing (EUL) after being found to be safe, effective, and quality assured following two doses of the inactivated vaccine," WHO Director-General Tedros Adhanom Ghebreyesus said at a WHO press briefing on Tuesday.

"Furthermore, the easy storage requirements of CoronaVac make it very suitable for low resource settings," he added.

In an official press release, WHO Assistant Director-General for Access to Health Products Mariangela Simao said: "The world desperately needs multiple COVID-19 vaccines to address the huge access inequity across the globe."

"We urge manufacturers to participate in the COVAX Facility, share their know-how and data and contribute to bringing the pandemic under control," she said.

COVAX is a global coalition that works to ensure fair and equitable access to COVID-19 vaccines around the world.

The CoronaVac vaccine, developed by Sinovac Life Sciences Co, Ltd based in Beijing, is also an inactivated vaccine, like the other and the first COVID-19 vaccine from China -- the Sinopharm vaccine, which was validated earlier last month for WHO emergency use.

Apart from the two Chinese vaccines, WHO has previously listed the COVID-19 vaccine developed by Pfizer/BioNTech, two versions of AstraZeneca/Oxford vaccine, the Janssen vaccine, and the Moderna vaccine for emergency use.

According to WHO's Strategic Advisory Group of Experts on Immunisation (SAGE), the Sinovac vaccine is recommended for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks.

The vaccine efficacy results showed that the Sinovac vaccine prevented severe COVID-19 and hospitalisation in 100 per cent of the studied population.

However, as few people over 60 years old were enrolled in clinical trials, SAGE said the Sinovac vaccine's efficacy could not be estimated in this age group.

"There is no reason to believe that the vaccine has a different safety profile in older and younger populations," the WHO statement said, adding that SAGE is not recommending an upper age limit for the vaccine, because data collected in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.

As in the cases of previously validated vaccines, WHO recommends that countries using the Sinovac vaccine in older age groups conduct safety and effectiveness monitoring to verify the expected impact and contribute to making the recommendation more robust for all countries.

Assessment by SAGE has shown that the Sinovac vaccine had been authorised by 32 countries or jurisdictions for use in adults 18 years or older, where 260 million doses have been distributed to the public in domestic and overseas markets. No safety concerns have been identified from pre-clinical or repro/tox studies, while most adverse events were mild to moderate, such as pain at the injection site, headache, fatigue and myalgia.

As more than 80 per cent of the COVID-19 vaccine doses globally have been administered in high-and upper-middle income countries and just 0.3 per cent in low-income countries, according to WHO's statistics, the two Chinese vaccines, with WHO's validation for emergency use, are expected to accelerate vaccine roll-out in many low-and middle-income countries through purchase and delivery by the WHO-led COVAX international COVID-19 vaccine initiative.

China has already decided to provide 10 million COVID-19 vaccine doses to the COVAX initiative to meet the urgent needs of developing countries, a concrete step to deliver on the promise to make vaccines a global public good.