The approval comes a day after Sinopharm said its vaccine is 79.34% effective, citing interim analysis of Phase 3 clinical trials.
China has drastically scaled up its vaccine emergency use program in recent weeks. Since December 15, it has administered more than 3 million vaccine doses on “key groups” in the population, Zeng Yixin, vice-minister of China’s National Health Commission, said at a news conference Thursday.
That’s on top of the 1.5 million doses administered on “high-risk groups” by the end of November, Zeng added.
Among those inoculated, fewer than 0.1% developed a light fever, and about two people per million developed “relative serious adverse reactions” such as allergies, according to Zeng.
Beijing Biological Products Institute Co., a Sinopharm subsidiary, said in a statement published Wednesday that interim results show the Sinopharm vaccine is safe and people who received two doses produced high-level antibodies.
But the statement gave no details on the data, such as the trial size, the number of infections in the trial and side effects.
By November, nearly 1 million people had received a Sinopharm vaccine, according to the company’s chairman, though he didn’t specify which of the company’s two vaccines they had received.
Though 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 Medical Products Administration.
A step closer to massive rollout
Sinopharm’s results were announced weeks after its global competitors. And with a lack of details, it remains unclear whether the information provided will be enough to dispel skepticism over the quality of Chinese vaccines.
Nevertheless, the announcement could still pave the way for the vaccine’s large-scale rollout both within China and globally.
China is ready to send hundreds of millions of doses to countries that have conducted last-stage trials for its leading vaccine candidates. Chinese leaders have also promised a growing list of developing countries priority access.
Beijing is using the global campaign as a soft power tool, analysts say, to try to repair any damage to its image from its early mishandling of the coronavirus pandemic.
Aside from the approved Sinopharm vaccine, China has four coronavirus candidates which have reached Phase 3 clinical trials — the last and most important step of testing before regulatory approval is sought. Having largely eliminated the spread of coronavirus inside its borders, Chinese drugmakers had to look abroad for places to test the efficacy of their vaccines. Together, they have rolled out Phase 3 trials in at least 16 countries.
Sinopharm’s two vaccine candidates, including the one approved in China, have rolled out Phase 3 trials in 10 countries, mostly in the Middle East and South America.
Compared with Pfizer and Moderna, Sinopharm’s vaccines do not require freezing temperatures for storage, making transport and distribution much easier — especially in developing countries that lack cold storage capacities.
Correction: An earlier version of this story misstated the number of “relative serious adverse reactions” to Chinese vaccine candidates. It is about two people per million among those inoculated.
CNN’s Beijing bureau contributed to reporting.
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