SAT Desk:
The Chinese government said on Thursday that it had given conditional approval to a homegrown coronavirus vaccine after an early analysis of clinical trial results showed that it was effective, sending a positive signal for the global rollout of Chinese vaccines. The candidate is the first one approved for general use in China.
The manufacturer, a state-controlled company called Sinopharm, said a vaccine candidate made by its Beijing Institute of Biological Products arm had an efficacy rate of 79 percent based on an interim analysis of Phase 3 clinical trials. Zeng Yixin, a deputy minister at the National Health Commission, said the vaccine would be provided to the Chinese public free, a reversal of previous official statements.
More than 60,000 people in countries like the United Arab Emirates and Bahrain had been vaccinated as part of the trials, Wu Yonglin of Sinopharm said at a media briefing organized by the government. But officials did not disclose crucial details about the vaccine, like any serious side effects that may have occurred in the trials or the demographic characteristics of the sample population — key data points that scientists look for in such releases.
Mr. Wu said that detailed data would be published later in major scientific research journals.
Chen Shifei, deputy director of the State Drug Administration, said at the briefing that Sinopharm had submitted the application for conditional use on Dec. 23, and that it had been approved a week later after a “comprehensive and detailed review.” He added that the conditional listing meant that the vaccine would be subject to a rolling review as Sinopharm continued its Phase 3 clinical trials.
In recent months, the Chinese authorities, citing emergency use, have pressed ahead with mass vaccinations before any of the country’s vaccine candidates have received official approval, in defiance of industry norms. An official from the National Health Commission said on Thursday that in the past two weeks, more than three million doses of China’s various vaccine candidates had been administered to key population groups within the country. Officials have said they plan to vaccinate 50 million people in China by mid-February, when hundreds of millions are expected to travel for the Lunar New Year holiday.
The Sinopharm vaccine’s results show that it is less effective than others approved elsewhere. Still, the results are well above the 50 percent threshold that makes a vaccine effective in the eyes of the medical establishment. As the global race to create vaccines for the disease intensifies, the Chinese companies have said their candidates — which use inactivated coronaviruses — have an advantage in that they are cheaper and easier to transport than those produced by companies like Moderna and Pfizer.
NY Times
