China approves Sinovac vaccine for widespread use against Covid-19

It is the second vaccine to receive approval for mass inoculation in China, after the state-run China National Pharmaceutical Group Co., better known as Sinopharm, which was approved in December. Last June, CoronaVac received authorization for emergency use 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 nations acquire vaccines developed in the West. CoronaVac can be stored in a regular refrigerator, making it cheaper and easier to transport than others that require subzero storage temperatures.

In addition to mainland China and Hong Kong, Turkey and Ukraine are among the nations that have reported CoronaVac orders. Brazil agreed to buy up to 100 million doses, while Turkey bought 50 million doses.

But CoronaVac has also faced increasing scrutiny over its effectiveness, after the drug was found to be less effective than originally published during final-stage tests in Brazil – dropping from 78% to about 50% – following the pressure from local scientists to test organizers to release more data.

The varying numbers of other countries testing CoronaVac have also raised questions about the protection offered by the Sinovac vaccine. In December, researchers in Turkey said the drug was just over 91% effective, while Indonesian authorities in January reported a 65.3% effectiveness rate from preliminary clinical trial results.

The president of Sinovac said the results from Turkey, Indonesia and Brazil proved that the vaccine was sufficiently safe and effective.

According to the company, which released details about CoronaVac tests in a statement on Saturday, clinical trials in Brazil showed that the vaccine offers complete protection against serious and deadly cases of the coronavirus. Effectiveness dropped to 83.7% for patients who contracted less severe cases that still required medical intervention, the company said. For even milder cases, the effectiveness was about 50.7%.

In Turkey, clinical trials showed that CoronaVac was about 91.3% effective, according to Sinovac, without detailing the numbers by case severity. More than 25,000 people outside of China participated in CoronaVac clinical trials, he said.

Earlier this week, the scientific journal The Lancet published new figures on the CoronaVac tests carried out on hundreds of people aged 60 and over in China, as tests in Turkey, Brazil and Indonesia did not include elderly participants.

He showed that the vaccine was safe for use and that it induced antibodies in the participants. This suggests that it will be effective for the older age group, although Sinovac needs to carry out Phase 3 tests on a larger number of people, and probably outside China, where the virus is still spreading.

Sinopharm and Sinovac vaccines are currently approved for use in China only for people aged 59 and under. Chinese officials said they would inoculate the elderly, although they did not say when. The state-run newspaper Global Times reported that the results of the initial study paved the way for the approval and expansion of the Sinovac vaccine in the elderly group.

The Chinese government, which actively promotes the country’s vaccines abroad, is also donating vaccines to less wealthy countries, such as Zimbabwe, which will receive 200,000 doses of the Sinopharm vaccine, according to Chinese state media. Beijing will also give 10 million coronavirus vaccines through the Covax initiative, the main global effort to provide vaccines to poor countries.

—Raffaele Huang and Chao Deng contributed to this article.

Write to Eva Xiao at [email protected]