Various reports point to the inoculation of nearly one million people with the COVID-19 vaccine developed by China National Pharmaceutical Group (Sinopharm) via an emergency use authorization in China. This means that lots of people were given the vaccine, despite the fact that it hasn’t been thoroughly tested in Phase 3 clinical trials. This past Wednesday, the firm reported that since the onset of the emergency program in July, a large number of individuals categorized as essential workers had been treated with the vaccine candidate, despite the fact that clinical trials have yet to prove that the vaccine is safe and effective. Interestingly, a program that allowed overseas construction workers to access the vaccine appears to evidence success as the company reports not one volunteer has been infected by COVID-19. But can these claims be believed? What are the rates of effectiveness? Unless the Chinese government can open up in meaningful ways, offering more transparency about such information, much news could be met with some healthy skepticism. For example, the way data is collected during an emergency program markedly differs from structured randomized controlled trials. But this vaccine could be working well, which would represent a promising milestone for the world community, much like the Pfizer/BioNTech and Moderna effectivity rates (95% and 94.5%, respectively) were met with great excitement in the U.S. and Europe. To some extent, China is competing against Russia, and in some cases, Western firms for COVID-19 vaccine global share. Although it would appear, Sinopharm, a 100%-Chinese government-owned operation, as well as Russia’s Sputnik V (state-owned) and to some extent the private Chinese firms of Sinovac and CanSino Biologics appear to be positioning their vaccine candidates as lower-cost options for low-to-middle-income countries known as LMICs.
Reuters reporters in China, including Roxanne Liu and Tony Munroe shared that the company shared this update on social media, including WeChat and referred to a recent interview with Chairman Liu Jingzhen.
The company has developed two COVID-19 vaccine candidates via their subsidiary China National Biotec Group (CNBG), while another Chinese company, Sinovac’s product, has been used in China under the emergency use authorization category. Another Chinese vaccine for the coronavirus, Ad5-nCoV produced by CanSino Biologics, was put to use by the military in lieu of a national Phase 3 clinical trial.
Which Sinopharm Vaccine?
Reuters reports that the specific vaccine that the company associated with the nearly one million dose administration is not clear, and Sinopharm wasn’t available for immediate comment. The inactivated-based vaccines require two doses, according to trial registration data reports Reuters.
Overseas Clinical Trials
The Chinese vaccine producers have made the world their Phase 3 laboratory, primarily because there just are not enough COVID-19 cases domestically. Although TrialSite argues that in select cases in China, the emergency use authorization serves as a sort of shortcut for the Phase 3 trial. For example, it seems fairly clear that in the case of Ad5-nCov5 that the military personnel serves as a proxy for a domestic Phase 3 trial. The ethics of this move are questionable, but China’s different political structure, command and control-based political economy and social culture stand in deep contrast to Western societies.
Worldwide, Sinopharm sponsors Phase 3 clinical trials now totaling over 60,000 volunteers, so over the next months, significant data should be made available. Transparency is important in biomedical research.
Call to Action: TrialSite will continue to monitor international vaccine candidates. Thus far, there have been no reports of widespread safety signals but the world’s news community focusing on life sciences should monitor all vaccine candidates, regardless of national origin.