HONG KONG: Chinese drug regulator has provisionally approved a Covid-19 vaccine developed by Chinese manufacturer Sinovac Biotech Ltd., which has faced questions about its vaccine effectiveness due to the lack of transparency around data from the US. clinical trials.
China’s National Medical Product Administration, the country’s top drug regulator, approved Sinovac’s CoronaVac vaccine on Friday, according to a statement from the agency, which gives it the green light for widespread use in China before from next week’s lunar New Year’s holiday.
It is the second vaccine to receive approval for mass inoculation in China, after that of the state-owned China National Pharmaceutical Group Co., better known as Sinopharm, which was approved in December. Last June, CoronaVac received emergency use authorization in China, which limited it to use in certain groups of high-risk people.
From Latin America to Africa and Asia, many developing countries have placed their hopes on CoronaVac and other Chinese vaccine candidates as richer nations capture inoculations developed in the West. CoronaVac can be stored in a normal refrigerator, making it cheaper and easier to transport than others that require storage temperatures below zero.
Beyond mainland China and Hong Kong, Turkey and Ukraine are some of the nations that have reported orders from CoronaVac. Brazil has agreed to buy up to 100 million doses, while Turkey has bought 50 million shots.
But CoronaVac has also faced increasing scrutiny over its effectiveness, after it was found that the drug was less effective than originally published during the final phase trials in Brazil — which fell 78% in the UK. 50% -, following pressure from local scientists for the organizers of the trial. to release more data.
Several numbers from other countries conducting CoronaVac trials 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 reported an efficacy rate of 65.3% in January based on preliminary results from clinical trials. .
The president of Sinovac has said that the results from Turkey, Indonesia and Brazil have shown that the vaccine was safe and effective enough.
According to the company, which released details of CoronaVac testing on Saturday, clinical trials in Brazil showed that the vaccine offered total protection against serious and fatal cases of coronavirus. Efficacy dropped to 83.7% for patients who contracted less severe cases that still required medical intervention, the company said. In even milder cases, the efficacy was 50.7%.
In Turkey, clinical trials showed that CoronaVac was about 91.3% effective, according to Sinovac, without detailing the severity of the case. More than 25,000 people outside of 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 aged 60 and over in China, as trials in Turkey, Brazil and Indonesia did not include elderly participants. .
It showed that the vaccine was safe to use and that it induced antibodies in the participants. This suggests that it will be effective for the older age group, although Sinovac should conduct phase 3 trials with a larger number of people, and probably outside China, where the virus is still spreading. .
Currently, Sinopharm and Sinovac vaccines are approved for use in China only for children under 59 years of age. Chinese authorities have said they would inoculate the elderly, though they have not said when. The state-run Global Times reported that the results of the first study paved the way for the approval and expansion of the Sinovac vaccine in the elderly group.
The Chinese government, which has actively promoted the country’s vaccines abroad, is also targeting less affluent countries, such as Zimbabwe, which will receive 200,000 doses of Sinopharm vaccine, according to Chinese state media. Beijing will also donate 10 million coronavirus vaccines through the Covax initiative, the world’s leading effort to provide vaccines to poor countries.
—Raffaele Huang and Chao Deng contributed to this article.
Write to Eva Xiao to [email protected]
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