China approves Sinovac vaccine for widespread use against Covid-19

HONG KONG – China’s Drug Regulatory Authority has granted provisional approval for a Covid-19 vaccine developed by Chinese doctor Sinovac Biotech Ltd., which has questioned the effectiveness of its vaccine due to a lack of transparency in the study data. clinical.

The National Medical Administration of China, the country’s main drug regulator, approved the CoronaVac vaccine from Sinovac on Friday, according to a statement from the agency, which gave it the green light for widespread use in China before the Lunar New Year celebration. next week.

It is the second vaccine to receive approval for mass inoculation in China, after that of the state-owned company China National Pharmaceutical Group Co., more commonly known as Sinopharm, which was approved in December. In June last year, CoronaVac received an emergency use permit in China, limiting it to use in certain groups of high-risk people.

From Latin America to Africa and Asia, many developing countries have put their hopes on CoronaVac and other Chinese vaccine candidates as richer nations capture inoculations developed in the West. CoronaVac can be stored in a regular refrigerator, making it cheaper and easier to transport than others that require below-zero storage temperatures.

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

But CoronaVac also faced increased control over its effectiveness after finding that the drug was less effective than it was originally published during late-stage studies in Brazil – dropping from 78% to about 50%. – following pressure from local scientists for the study’s organizers to release more data.

A number of other countries conducting CoronaVac studies 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 the Indonesian authorities reported an efficacy rate of 65.3% in preliminary clinical trial results in January.

President Sinovac said results from Turkey, Indonesia and Brazil proved that the vaccine was safe and effective enough.

According to the company, which published details of CoronaVac tests in a statement on Saturday, clinical trials in Brazil showed that the vaccine offered total protection against severe and fatal cases of coronavirus. Efficacy has dropped to 83.7% for patients who have contracted less severe cases that still require medical intervention, the company said. For even milder cases, the effectiveness was about 50.7%.

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

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

He showed that the vaccine is safe to use and that it induces antibodies in participants. This suggests that it will be effective for the older age group, although Sinovac should conduct phase 3 studies 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 those aged 59 years or younger. Chinese authorities have said they will inoculate the elderly, although they have not said when. The state-run newspaper Global Times reported that the results of the early study paved the way for the approval and extension of the Sinovac vaccine in the elderly group.

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

Write to Eva Xiao at [email protected]

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