China approves Sinovac vaccine for wide use against Covid-19

It is the second vaccine to receive mass vaccination approval in China after that of state-owned China National Pharmaceutical Group Co., better known as Sinopharm, which was approved in December. Last June, CoronaVac received an emergency use permit in China, limiting its use to certain groups of high-risk individuals.

From Latin America to Africa and Asia, many developing countries have pinned their hopes on CoronaVac and other Chinese vaccine candidates as wealthier countries begin vaccinations developed in the West. CoronaVac can be stored in a regular refrigerator, making it cheaper and easier to transport than other refrigerators that require storage temperatures below freezing.

Outside of mainland China and Hong Kong, Turkey and Ukraine are among the countries that have reported orders for CoronaVac. Brazil has agreed to buy up to 100 million doses, while Turkey has bought 50 million shots.

But CoronaVac has also gained increasing attention for its effectiveness after it was found to have lower efficacy than originally published in late-stage studies in Brazil – from 78% to about 50% – under pressure from local scientists for the survey organizers to release more data.

Varying numbers from other countries conducting CoronaVac studies have also raised questions about the protection offered by Sinovac’s vaccine. In December, researchers in Turkey said the drug was just over 91% effective, while Indonesian authorities reported an efficacy rate of 65.3% in January based on preliminary results from clinical trials.

Sinovac’s chairman said results from Turkey, Indonesia and Brazil have shown that the vaccine is sufficiently safe and effective.

According to the company, which released details on CoronaVac tests in a statement on Saturday, clinical trials in Brazil showed that the vaccine provided total protection against serious and fatal cases of the coronavirus. The efficacy dropped to 83.7% for patients who had developed minor cases that still required medical intervention, the company said. For even milder cases, the efficacy was approximately 50.7%.

In Turkey, clinical studies showed that CoronaVac was approximately 91.3% effective, according to Sinovac, without specifying the grades by severity. More than 25,000 people outside of China have participated in clinical trials with CoronaVac.

Earlier this week, the science magazine The Lancet released new figures on CoronaVac tests conducted on hundreds of people aged 60 and older in China, as trials in Turkey, Brazil and Indonesia did not involve older participants.

It showed that the vaccine was safe to use and that it induced antibodies in the participants. That suggests it will be effective for the older age group, although Sinovac should be conducting Phase 3 studies in a greater number of people, and probably outside of China, where the virus is still spreading.

Sinopharm and Sinovac vaccines are currently only approved for use in China for individuals aged 59 and under. Chinese authorities have said they would vaccinate the elderly, although they have not said when. The state-run Global Times newspaper reported that the results of the early study paved the way for approval and expansion of the Sinovac vaccine in the elderly.

The Chinese government, which has actively promoted the country’s vaccines abroad, is also donating shots to less prosperous countries, such as Zimbabwe, which will receive 200,000 doses of Sinopharms vaccine, according to Chinese state media. Beijing will also provide 10 million coronavirus vaccines through the Covax Initiative, the leading global effort to provide vaccines to poor countries.

—Raffaele Huang and Chao Deng contributed to this article.

Write to Eva Xiao at [email protected]