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(CNN) – Chinese regulators have approved the country’s first homegrown coronavirus vaccine, developed by state pharmaceutical giant Sinopharm, officials announced Thursday.
The approval comes a day after Sinopharm said its vaccine is 79.34% effective, citing an interim analysis of phase 3 clinical trials.
READ: Palace defends military use of unregistered COVID-19 vaccines
China has dramatically expanded its emergency vaccine use program in recent weeks. Since December 15, it has administered more than 3 million doses of vaccines to “key groups” of the population, Zeng Yixin, vice minister of China’s National Health Commission, said at a news conference on Thursday.
That is in addition to the 1.5 million doses administered in “high-risk groups” in late November, Zeng added.
Among those inoculated, less than 0.1% developed a mild fever, and about two people per million developed “relatively serious adverse reactions,” such as allergies, according to Zeng.
Beijing Biological Products Institute Co., a subsidiary of Sinopharm, said in a statement released Wednesday that interim results show that the Sinopharm vaccine is safe and that people who received two doses produced high-level antibodies.
But the statement did not elaborate on the data, such as the size of the trial, the number of infections in the trial, and side effects.
The coronavirus vaccines developed by Sinopharm have already been administered to hundreds of thousands of people under a controversial emergency use program approved by the Chinese government.
By November, nearly 1 million people had received a Sinopharm vaccine, according to the company’s president, although he did not specify which of the company’s two vaccines they had received.
Although few details were provided, the statement released Wednesday said the vaccine met the standards of the World Health Organization and China’s own regulator, the National Administration of Medical Products.
The Sinopharm vaccine is less effective than those developed by Pfizer-BioNTech and Moderna, which have an efficacy rate of approximately 95%. Russia says its Sputnik V vaccine is 91% effective.
And the 79% vaccine efficacy rate is lower than the 86% announced by the United Arab Emirates for the same vaccine on December 9. The United Arab Emirates based its results on an interim analysis of late-stage clinical trials conducted there since July. He has since approved the vaccine for public use.
The Sinopharm vaccine has a higher efficacy rate than that developed by the UK’s Oxford University and AstraZeneca, which averaged 70%. On Wednesday, the UK became the first country to approve that vaccine for public distribution.
One more step towards mass launch
Sinopharm’s results were announced weeks after its global competitors. And in the absence of details, it is unclear whether the information provided will be enough to dispel skepticism about the quality of Chinese vaccines.
However, the announcement could still pave the way for the large-scale launch of the vaccine both in China and globally.
The country aims to inoculate 50 million people with homegrown Covid-19 vaccines ahead of the Lunar New Year celebrations in February, a Chinese vaccination expert confirmed to CNN earlier this month.
China is ready to ship hundreds of millions of doses to countries that have conducted late-stage trials for their top vaccine candidates. Chinese leaders have also promised a growing list of developing countries with priority access.
Beijing is using the global campaign as a soft power tool, analysts say, to try to repair any damage to its image due to its early mishandling of the coronavirus pandemic.
In addition to the approved Sinopharm vaccine, China has four coronavirus candidates that have reached phase 3 clinical trials, the last and most important testing step before regulatory approval is sought. Having largely eliminated the spread of the coronavirus within their borders, Chinese drug makers had to look abroad for places to test the efficacy of their vaccines. Together, they have implemented Phase 3 trials in at least 16 countries.
Sinopharm’s two candidate vaccines, including the one approved in China, have implemented phase 3 trials in 10 countries, primarily in the Middle East and South America.
Sinopharm Chairman Liu Jingzhen said last month that dozens of countries have applied to buy the company’s vaccines. It did not name the countries or elaborate on the number of doses they proposed, but said CNBG was capable of producing more than 1 billion doses in 2021.
Compared to Pfizer and Moderna, Sinopharm vaccines do not require subzero temperatures for storage, making transportation and distribution much easier, especially in developing countries that lack cold storage capacity.
This was first published on CNN.com.
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