The Hong Kong-China drug regulator has given provisional approval to a Kovid-19 vaccine developed by Chinese pharmaceutical manufacturer Sinovac Biotech Ltd., which has questioned its vaccine efficacy due to a lack of transparency around clinical data.
The country’s top drug regulator, China’s National Medical Products Administration, approved the Synovac’s Coronavac vaccine on Friday, according to an agency statement, giving it the green light for widespread use in China before next week’s Lunar New Year holiday Has gone.
It is the second vaccine to receive approval for large-scale vaccination in China, known as the state-owned China National Pharmaceutical Group Company, commonly known as Cyanoform, in December. Was approved. Last June, Coronavac received emergency-use authorization in China, limiting it to use in certain groups of high-risk individuals.
From Latin America to Africa and Asia, many developing countries have placed their hopes on Coronavac and other Chinese vaccine candidates as developed countries in the West sided with wealthy countries. The Coronavac can be stored in a simple refrigerator, making it cheaper and easier than others that require subzero storage temperatures.
Beyond mainland China and Hong Kong, Turkey and Ukraine are among the countries that reported Coronavac’s orders. Brazil has agreed to buy 100 million doses, while Turkey has bought 50 million shots.
But Coronavac has also faced increasing scrutiny over its effectiveness, as the drug was found to have lower efficacy than it was originally published during late-stage trials in Brazil – 78 from local scientists for the trial’s organizers Dropping pressure from% to about 50%. To release more data.
Different numbers from other countries that have conducted the Coronavac trials have also raised questions about the safety of synovac vaccines. In December, researchers in Turkey said the drug was only more than 91% effective, while Indonesian authorities in January reported an efficacy rate of 65.3% from the preliminary results of clinical trials.
The president of Synovac has stated that results from Turkey, Indonesia and Brazil have proved that the vaccine was sufficiently safe and effective.
According to the company, which published details on the Coronavac tests in a statement on Saturday, clinical trials in Brazil showed that the vaccine offered total protection against severe and fatal cases of coronovirus. The company said the efficacy fell to 83.7% for patients contracting in less severe cases, which still required medical intervention. Even for mild cases, the efficacy was about 50.7%.
In Turkey, clinical trials have shown that Coronavac was about 91.3% effective, according to Synovac, without seriously detailing the numbers. More than 25,000 people have participated in the Coronavac clinical trials outside China.
Earlier this week, the scientific journal The Lancet published new data on the Coronavac tests, which were conducted in China on hundreds of people aged 60 and older, as trials in Turkey, Brazil and Indonesia did not include elderly participants it was done.
It was shown that the vaccine was safe to use and that it induced antibodies in participants. It suggests that it will be effective for the aging group, although Synovac will need to conduct phase 3 tests on a greater number of people, and likely outside of China where the virus is still spreading.
Vaccines by Sinopharma and Synovac are currently only approved for use in China for 59 years and younger. Chinese officials have said that they will vaccinate the elderly, although they have said no. The state-run Global Times newspaper reported that the results of the initial study paved the way for the approval and expansion of the Synovac vaccine in the elderly cohort.
The Chinese government, which has actively promoted the country’s vaccines abroad, is also donating shots to less affluent countries such as Zimbabwe, which, according to Chinese state media, will receive 200,000 doses of Sinpharma vaccines. Beijing will also deliver 10 million coronavirus vaccines through the Coxax initiative, the main global effort to provide vaccines to poor countries.
– Rafael Huang and Chao Deng contributed to this article.
write to Eva Xiao at [email protected]
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