China approves vaccine trials for coronavirus

2020-03-18 Global Times Editor：Li Yan

Nation expected to go one step ahead due to system advantages

About 19 hours after the U.S. announced it would start human trials for the first coronavirus vaccine, China revealed its own initial trials on the first vaccine the country developed, showing that the two largest economies are on par in the race to save the public health crisis. Given China's system advantages, for example, in accelerating the examination and approval procedure, the country is expected to be ahead in putting the vaccine into the market, analysts said. Although the vaccine will likely not be available for wide use for another 12-18 months, it gave the world great hope in combating the disease.

After arriving at Wuhan, Chen Wei, a Chinese military major general, and her team launched pharmacy, pharmaceutical and toxicological research on COVID-19 vaccine in cooperation with local companies, based on their previous successful experiences in developing Ebola vaccine.

They quickly finished design, recombination, and production under the Good Manufacturing Practice and quality control review of the vaccine, according to CCTV.

The coronavirus vaccine developed by Chen's team passed the registration review of clinical research and was approved for clinical trial on Monday night.

She also noted that, consistent with international norms and domestic regulations, vaccines have been prepared for safe, effective, controllable quality and mass production.

On Tuesday, U.S. media reported that the first dose of a COVID-19 vaccine developed in the country had begun clinical trials on Monday on 45 healthy volunteers, citing U.S. health officials.

And local scientists estimated that the vaccine will likely not be available for wide use for another 12-18 months.

Dozens of countries and regions have joined a "vaccine race" since the outbreak. Now as China and the U.S. come to the same position in vaccine development, Chinese experts held that China would probably go one step ahead due to systematic advantages.

Work together

In China, military has been leading ahead in vaccine research and development, and the People's Liberation Army (PLA) Academy of Military Medical Sciences has abundant research forces in this field, Yang Gonghuan, a former vice director of the Chinese Center for Disease Control and Prevention, told the Global Times on Tuesday.

"I believe other institutions including national CDC, Chinese Academy of Sciences and some hospitals are advancing relevant researches too," she said.

The military has advantages in vaccine development as they face less restrictions - for example, in reaching samples and advanced experimental conditions, compared to private companies and institutes, which is a decisive factor, according to a Beijing-based immunologic expert who requested anonymity.

On the contrary, the U.S. will be less compatible in joint work as it has to follow market operations, the expert said.

Media reported that Chen and her team took over the Wuhan Institute of Virology, the only P4 laboratory in use in Asia, after arriving in the city.

The vaccine approved to clinical trial is jointly developed by the team led by Chen, who is also an academician at the PLA Academy of Military Medical Sciences, and a Tianjin-based biotechnology company CanSino Biologics Inc, according to the media report.

Private enterprises in China may not have such strong research capabilities in the field of vaccine research compared to those of the U.S., but military sciences system has strong footprints in this domain, Yang noted.

Chen, the military scientist, was quoted as saying in the report that the vaccine has been tested on safety, effectiveness and quality control and is prepared for massive production. And the biotechnology firm has started to recruit volunteers for the vaccine.

Chen's team has worked with CanSino previously on Ebola. A recombinant Ebola vaccine they developed was approved in October 2017 by the China Food and Drug Administration, which is the third approved Ebola vaccine in the world and the first in Asia.

In April, most of the eight research teams with missions assigned by the Chinese central government are expected to complete preclinical preparations and gradually start clinical trials, according to earlier reports.

China is developing a COVID-19 vaccine using five technical routes, including inactivated vaccine, attenuated influenza virus vaccine and nucleic acid-based vaccine, Wang Junzhi, an academician at the Chinese Academy of Engineering, told a press conference on Tuesday in Beijing.

Top priority

China has given priority to vaccine development as early as the onset of the outbreak and has been accelerating the procedure according to law as well as on the premise of safety and effectiveness. China would not lag behind foreign counterparts in vaccine development, Wang said.

China's health authority previously said that part of the vaccines might be available in April for use in emergency situations, given the five technical routes - including inactivated vaccine, attenuated influenza virus vaccine and nucleic acid-based vaccine - that the country is following in vaccine development.

According to Chinese law, emergent usage of a vaccine is allowed in a certain scope and period when public health is seriously threatened.

Analysts said that it is not impossible to see such usage of a vaccine in April if it has undergone clinical trials at that time.

On the contrary, Yu Dong, a former research fellow of British pharmaceutical company GlaxoSmithKline, told media in March that such short-cut approach might be impossible in the U.S. due to its comparatively low confirmed cases and strict procedures.

Compared to the U.S., China's advantages are reflected in the examination and approval process, which is faster than the U.S.. This was also thanks to China's system advantages that mobilize national efforts and resources to tackle key problems, Yang Zhanqiu, a virologist at Wuhan University, told the Global Time on Tuesday.

"China and the U.S. are now on the same footing in the field of vaccine research," he said, noting that human experiments are expected to be conducted in two months.

Companies started to develop vaccines at the same time, while no one has had exclusive core technology, in which China has not been falling behind of the U.S., according to the analyst. Pushing forward the development of vaccines is a major test for scientific research institutions and biology companies to see which one react faster toward the epidemic.

Despite the progress, Chinese scientists and experts are cautious toward the vaccine development as it usually takes about 10 years from developing it to successfully putting it to use.

"Because it's preventive, it requires higher level of safety. Given the current situation, even if it goes through a rapid process, I feel that it would take at least a year," the Beijing-based immunologic expert said.

Yang, former deputy director of China's CDC, also noted that although we have some knowledge on the characteristics of COVID-19, it is just the beginning. "How long the immunity would last after the vaccine is successfully developed is hard to predict."

Cautiously optimistic

A major breakthrough achieved by Chen's team in developing a vaccine for coronavirus was first reported on March 3 by CCTV, which also outlined a series of research achievements made by the Academy of Military Medical Sciences, including virus testing kits, medicines and vaccine.

However, the information on such a major breakthrough was only briefly mentioned in the CCTV report and many social media platforms later deleted the related information, suggesting the Chinese government's prudent attitude on vaccine development as well as the unpredictable development process itself.

The COVID-19 vaccine using the flu virus as a carrier that China is developing is likely to go on clinical trials at the end of April, Lei Chaozi, director of the Department of Science and Technology of the Ministry of Education, said at a Tuesday press conference.

Some Chinese colleges are also using their experience in MERS research to develop a nucleic acid-based vaccine for COVID-19. The nucleic acid-based vaccine is a new technology and no product has been approved and put on the market in the world as of now, Lei said.

Some colleges have also isolated anti-bodies for the novel coronavirus from plasma donated by recovered patients and created a product that can provide short-term immune protection for about three weeks.

The product is ready for animal trials, Lei said.

Developing coronavirus vaccines is a highly demanding task, as for now there is no one vaccine that has been commercialized because none has been successfully developed, the expert who preferred not to be named noted.

"Developing one is only the first step, which is far from being successful," the expert said.

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