On August 31, TrialSite reported that Chinese regulators were expediting acceptance of drug makers’ investigational products with emergency use authorizations for Sinovac Biotech’s (Sinovac) CoronaVac, Sinopharm, as well as CanSino Biologics’ Ad5-nCoV, the latter of which was offered on an exclusive basis to the Chinese military. Now Sinovac spokesperson Liu Peicheng has confirmed that nearly all of their 3,000 employees have actually been inoculated with the experimental CoronaVac. Additionally, the company purportedly ramped up its production line—they can purportedly produce 300 million doses per month. According to Chinese press, CEO Yin Weidong is confident that regulators will approve of the vaccine before end of year. Based on unfolding current events China, as well as the expedited situation with Russia’s Sputnik V, these “East” nations aggressively expedite COVID-19 vaccines for emergency use, TrialSite suspects, as a means to mitigate the imminent risk from an anticipated fall and winter COVID-19 outbreak. With economic implications, those countries that are not substantially impacted (e.g. shut down) can keep businesses open and commerce flowing and hence economies moving. On the other hand, the United States and other traditional Western, democratic nations focus more on safety—although accelerating vaccine research—still maintain more rigorous standards for vaccine inoculation and commercialization—with an emphasis on patient safety and the formal process over expediency.
Experimental Vaccine as Economic Risk Mitigation
It would appear that in Russia and China, authorities are embracing the emergency use authorization (EUA) as a means of mitigating economic risk in anticipation of future COVID-19 outbreaks this fall and winter. Already, CoronaVac is administered to those deemed “at risk,” such as medical professionals, first responders, and even border officials, reports Guo Rui and Orange Wang from South China Morning Post. Apparently, the Chinese government is making these experimental vaccines available to all aviation employees.
Already tens of thousands of people, starting in Beijing, received the experimental vaccine CoronaVac, including workers at Xinfadi food market where a significant COVID-19 breakout occurred in June. In concert with the government, Sinovac’s vaccine is being used as a risk mitigation tool to protect the Chinese economy, with a focus on anticipating the forthcoming autumn and winter seasons, CEO Yin was quoted recently.
China National Biotec Group Follows
Now the South China Morning Post reports China National Biotec Group (CNBG) follows along, as that company, part of Sinopharm, treats its own employees with its’ experimental vaccine not approved yet. For example, Zhang Yinan, deputy general marketing manager, reports she was given her company’s vaccine product, proudly declaring, “After animal testing, I’m willing to try the company’s product to see if its safe and effective, and there are 150 employees like me who have been inoculated.”
Phase 3 Clinical Trials Abroad Coupled with Purchases
Of course, CNBG and Sinovac are also executing on large Phase 3 clinical trials in other countries around the world. CNBG has expedited a Phase 3 study treating over 35,000 people in the United Arab Emirates, which has also entered into a purchase agreement.
In the meantime, Sinovac reports its conducting Phase 3 trials in Turkey, Bangladesh, Brazil and Indonesia; they also tout commercial orders but don’t name actual customers. TrialSite reported on the deal between Sinovac and Indonesia’s PT Bio Farma, the state-owned biotech venture. Indonesia would participate in the Phase 3 clinical trial while also purchasing 100 million doses. Ms. Liu claims that the Indonesian deal was the company’s largest to date for a “Chinese vaccine company.”
Rui and Wang for South China Morning Post write that Indonesia secured a first batch of 40 million “semi-finished CoronaVac” doses from Nov 2020 to March 2021 followed by more orders, more than likely, later in that year. Bio Farma serves as the local pharmaceutical intermediary and distributor.
Bypassing Jurisdictions for Expedited Approval
Sinovac’s executives are urging regulators in other countries to expedite approvals if it turns out study results go well in a particular country. CEO Yin, for example suggests if the studies data in Brazil looks good for CoronaVac, then a country such as Indonesia should make the move and accelerate the approval.
Western Safety vs. Eastern Expediency
It would appear that there is a clear divergence involving vaccine research and release strategy between the West (e.g. North America and Europe) and the East (China and Russia). The latter in this pandemic have made it a practice of, at least in the case of Russia, employing some forms of human challenge programs (Gamaleya researchers were testing Sputnik V on themselves before trials even started!), while both China and Russia have implemented a far more flexible and aggressive (and some would say dangerous) approach when it comes to emergency use authorization than is the case in in the West. In places like the United States, the UK, and Germany, for example, the standards for progressing from a Phase 2 clinical trial directly to an emergency use authorization appears far more stringent. And, of course, this type of rigor exists for good reason: patient safety.
On the other hand, there has been chatter in news and TrialSite’s network that an emergency use authorization for one of the vaccine candidates in the West could be in play should the benefits clearly outweigh the risks. In fact, White House chatter has signaled an interest in the possibility of an EUA prior to the completion of late-stage trials. However, Dr. Anthony Fauci recently informed Reuters, “the one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy.” Dr. Fauci continued, “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial.”
TrialSite agrees with Dr. Fauci—better safe than sorry.