Interim analysis of Phase 3 clinical trials shows that the vaccine is safe and people given two doses produced high-level antibodies, according to a statement published Wednesday by Beijing Biological Products Institute Co., a subsidiary of Sinopharm.
The company said it requested formal approval from Chinese regulators to distribute the vaccine to the public.
According to the company’s chairman, nearly one million people had received a Sinopharm vaccine by November, although he had not indicated which of the two vaccines they had received.
While few details were provided, the statement released Wednesday said the vaccine met the standards set by the World Health Organization and China’s own regulator, the National Medical Products Administration.
One step closer to massive rollout
Sinopharm’s results were announced weeks after its global competitors. And in the absence of details, it remains unclear whether the information provided will be enough to dispel skepticism about the quality of Chinese vaccines.
Nevertheless, the announcement could still pave the way for the large-scale introduction of the vaccine, both in China and worldwide.
China is poised to send hundreds of millions of doses to countries that have completed the final phase of trials for its top vaccine candidates. Chinese leaders have also promised a growing list of priority access for developing countries.
Beijing is using the global campaign as a soft power tool, analysts say, to try to repair any image damage caused by the early mishandling of the coronavirus pandemic.
China has five coronavirus candidates from four companies that have reached phase 3 clinical trials, the final and most important step of testing before seeking regulatory approval. After the spread of the coronavirus was largely eliminated within its borders, Chinese drug manufacturers had to look abroad for places to test the efficacy of their vaccines. Together they have rolled out phase 3 studies in at least 16 countries.
Sinopharm’s two vaccine candidates are undergoing phase 3 trials in 10 countries, mainly in the Middle East and South America.
Compared to Pfizer and Moderna, Sinopharm’s vaccines do not require freezing temperatures for storage, which makes transportation and distribution much easier – especially in developing countries that lack cold storage capacity.
CNN’s Beijing office contributed to the reporting.