China Poised for First Approval of Coronavirus Vaccine

With four medicines in Phase III clinical trials, Beijing regulators reportedly are ready to launch this month - ahead of U.S., European competitors.
Mark MelnicoeOct 10,2020,13:59

China now appears likely to approve and roll out a coronavirus vaccine ahead of the U.S. and Europe – possibly this month – in a development that should stun the West and demonstrate the speed at which Beijing’s technological development is catching up.

Four vaccines are in advanced Phase 3 trials, and hundreds of thousands of Chinese people already have been vaccinated outside the trials. The Chinese vaccines come from three companies - CanSino Biologics (HK: 6185), privately held Sinovac Biotech, and two from state-owned Sinopharm (HK: 1099), which is China’s largest pharmaceutical company. They are competing with the likes of AstraZeneca (Nasdaq: AZN), Johnson & Johnson (NYSE: JNJ), Moderna (Nasdaq: MRNA). Pfizer (NYSE: PFE) and other Western powerhouse pharma companies.

Phase 3 is the biggest and final phase of human testing before vaccines are approved for public use. They demonstrate the medicines will work in large numbers (thousands) of people. But already, several hundred thousand Chinese have received shots under so-called emergency use authorization.

They include essential health-care workers, staff at the vaccine companies and government employees, especially in Beijing, according to SupChina, a New York-based China-focused news portal. It’s not unusual for medical workers to get vaccinated during Phase 3 trials, before actual approvals, although it’s taking place on a pretty vast scale in China. The Nikkei Asian Review reports that Sinovac has vaccinated some 90% of its workers and their families, and that Sinopharm told Chinese state media that it has reached 350,000 people with “emergency innoculations.”

Formal Launch May Be This Month

President Trump, who is conducting a vicious trade, technology and rhetorical war against China, has been pushing to get an American-made vaccine approved before the Nov. 3 presidential election. But as the world waits for such an achievement, for which Trump will take credit under his “Operation Warp Speed” push, it seems that Beijing is about to go first with a formal launch.

That could happen before the end of October, according to Yiwu He, chief innovation officer at the University of Hong Kong, as reported by the New Yorker. He said that Sinopharm’s China National Biotech Group (CNBG) likely will be the first “under some kind of approval.” The magazine also quoted a Beijing-based biotech investor as saying CNGB was near the end of its Phase 3 trials and was already filing application papers to be first out the gate.

“In normal times, approval could take between six months and a year, but people in the industry told me that the process will be accelerated because of pressures related to both the pandemic and politics,” the New Yorker’s Peter Hessler wrote.

Chinese companies are running their trials in more than a dozen countries, in part because Beijing has stamped out Covid-19 so thoroughly that China is a worthless place to test; there is essentially no danger of anyone becoming infected. Contrast that with many South American countries (Peru, Brazil, Argentina), Middle Eastern nations and others than include Turkey, Pakistan, Indonesia and Russia, and that’s where Chinese trials are taking place.

Once approval comes, the Middle Kingdom is ramping up to manufacture enough doses not only for its own massive population but to supply many of these countries, as well. Public opinion of both the U.S. and China has plummeted in recent years, as measured by the Pew Research Center and others. China’s fall is due in part to its handling of the coronavirus, which of course originated in Wuhan and was initially covered up by local officials there. Once Beijing got wind of what was going on with the new virus, it pivoted quickly and took strong measures, including sharing the genome with global researchers. But a lot of damage was done, and it doesn’t help when Trump continues to label it the “Chinese virus” and openly blames Beijing for infecting the world.

Leaving Behind the History of Fake Vaccines

China has a lot to gain by providing a vaccine, which it is promising to many countries. On Friday, it signed on to a global alliance called the COVAX Facility, which aims to equitably distribute a coronavirus vaccine. The effort is led by the World Health Organization and has 170 countries signed up – most of the world. Notably, the U.S. – which has condemned WHO for “siding with China” – and Russia have not signed on. The alliance aims to distribute 2 billion doses worldwide by the end of next year.

One would think the companies producing vaccines are gaining. But that is not consistently the case. Sinopharm shares are trading at around $17 on the Hong Kong Stock Exchange, against a 52-week high of $29.55. That’s because the firm has more than 1,100 subsidiaries, so its vaccines are anything but a pure play.

In the case of CanSino, the Motley Fool notes that it failed to make big headlines in July when it got approval to vaccinate thousands of members of the Chinese military. In part it blamed what it called intense side effects of its drug and said that few outside China have expressed interest in manufacturing it. CanSino’s stock peaked in late July amid triple-digit growth but has fallen nearly 40% since then amid flat trading volume.

Despite lackluster stock performance and what some would consider reckless behavior by providing vaccines before they are approved, China’s stature has gained tremendously in the pharmaceutical sphere in recent years. Gone are the days of scandals involving faked clinical trials results and contaminated drugs.

Now the Chinese are developing and manufacturing world-class vaccines, anti-cancer drugs and biologics at campuses around Shanghai, Beijing and other major cities. It is one of the sectors the nation is pushing in its Made in China 2025 plan to lead the world in key technologies such as advanced materials and artificial intelligence.

Now, one of the first big payoffs in that program may be about to gain the attention of a world desperate for relief from the coronavirus pandemic.

Topics:vaccine, coronavirus, Sinovac, Sinopharm, CanSino