This service trade fair is the first large-scale international economic and trade event held in China since the outbreak of the new crown pneumonia epidemic.
In this context, the public health and epidemic prevention special exhibition area with the theme of "Health and Safety for All" has attracted much attention.
Zhong Nanshan, an academician of the Chinese Academy of Engineering who was awarded the "Medal of the Republic", once pointed out that the most fundamental solution to the new crown pneumonia is a vaccine.
At this service trade conference, three domestically-made new crown vaccines made their public debut for the first time.
During the 6-day exhibition period, the relevant booths located in the comprehensive exhibition area on the first floor of the National Convention Center were very popular, becoming the place with the highest "check-in rate".
These 3 vaccines are also called "will pet" and "new crown vaccine national team" by netizens.
These three vaccines are all inactivated vaccines, two of which are from China Biotechnology Co., Ltd. (hereinafter referred to as China Biotechnology) and one from Kexing Holding Biotechnology Co., Ltd. (hereinafter referred to as Kexing Bio).
Currently, these three vaccines are selected for phase III clinical trials overseas, including Brazil, Indonesia, UAE, Jordan, Peru, Morocco, Pakistan, etc.
It is understood that after mass production, the annual output of the two companies will reach 600 million.
Studies have shown that the new crown vaccination begins to generally produce antibodies 7 days after vaccination, and it is expected to last 1 to 3 years.
What stage is the domestic new crown vaccine development going to?
Who was vaccinated in advance?
How effective is the vaccine?
Why should Phase III clinical trials be conducted overseas?
A reporter from China Economic Weekly interviewed relevant industry insiders on the above issues at the service trade fair.
A total of 8 vaccines worldwide have entered clinical phase III trials, half of which are domestic products
"At present, tens of thousands of people in Beijing should have been vaccinated with Kexing Biological's new crown vaccine." Kexing Biological Chairman, President and CEO Yin Weidong told a reporter from China Economic Weekly.
A few days ago, Zheng Zhongwei, director of the Science and Technology Development Center of the National Health Commission and leader of the vaccine research and development team of the Joint Prevention and Control Mechanism of the State Council, told the media that my country has officially launched the emergency use of the new crown vaccine on July 22.
Beijing is the first city to launch an emergency vaccine program.
The "Vaccine Management Law" clearly stipulates that when a particularly major public health event occurs, the National Health Commission shall submit an application for emergency use of vaccines, and the State Food and Drug Administration shall organize experts to demonstrate and agree, and the National Health Commission shall set a certain scope and time limit. Emergency use of vaccines.
So who in Beijing is given priority to get the new crown vaccine?
According to Yin Weidong, there are four main categories of people who have been vaccinated against the new crown. The first category is foreign-related people and key populations who need to go abroad for business; the second category is high-risk populations who will be exposed to the epidemic during work. Circulation personnel in the control center"; the third category is medical personnel, such as doctors and nurses in fever clinics; the fourth category is related personnel in vaccine research and development and vaccine production companies.
"I was vaccinated myself." Yin Weidong said.
In fact, in addition to Kexing Bio's inactivated vaccines, my country has also deployed other vaccine technology routes.
"Since February, my country has laid out a total of 5 new crown vaccine technical routes, identified 12 research and development units, and fully promoted vaccine research." On September 6, Zheng Zhongwei said at the Public Health Forum of the Service and Trade Association.
It is understood that China's new crown vaccine development mainly chooses five main technical routes: inactivated vaccines, subunit vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines and nucleic acid vaccines.
Zheng Zhongwei said that currently on these five technical routes, "full coverage of clinical trials has been achieved." That is, on each technical route, vaccines have entered clinical trials.
According to the global vaccine research and development data report released by the World Health Organization, as of September 3, a total of 176 new crown vaccine products are being developed around the world, of which 34 vaccines have entered clinical trials, 8 vaccines have entered clinical trials, while China The products developed by the enterprise account for 4 products.
In fact, as early as April, the new crown vaccine developed by the team led by Chen Wei, an academician of the Chinese Academy of Engineering and a researcher at the Academy of Military Medicine, has already attracted attention.
Currently, phase III international clinical trials of the vaccine are also progressing in an orderly manner.
"This vaccine has independent intellectual property rights, which means that we do not need to look at the faces of others to develop our own vaccines at any time and on any occasion. When the subsequent vaccine is put into production and application, we can also make the Chinese people in need at a lower price. At that time, get the vaccination as soon as possible." Chen Wei told the media before.
Retail price positioning at hundred yuan level
Yin Weidong said that the protection effect after vaccination should be considered from two aspects.
"Safety is an indicator, whether there is a fever, what are the adverse reactions, etc., this is safety. The other is effectiveness, that is, whether antibodies are produced after vaccination." Yin Weidong said that in phase I and II clinical trials, almost all vaccination All of them developed antibodies and no serious adverse reactions occurred.
It is worth noting that the results of phase I and II clinical studies show that the vaccine has good safety and immunogenicity, that is, a higher titer of neutralizing antibodies is produced, but how high a titer of neutralizing antibodies can prevent the new coronavirus Infection remains to be answered by phase III clinical studies.
Regarding the issue of the price of the domestic new crown vaccine that the public is most concerned about, Yin Weidong bluntly said that due to different purchasers and different purchase scales, the price will eventually fluctuate to a certain extent.
"National-level purchases are bulky, and the price will be lower; corporate purchases are also bulky, but not as large as national-level purchases, and the price will be slightly higher; the personal order quantity is relatively small, and the price is among the three purchasing methods. The highest." As for the final retail price, the relevant persons in charge of the two companies, China Biotech and Kexing Biotech, said that it will be a price affordable by the people, fixed at the 100 yuan level.
The domestic vaccine has not been officially put into production, and overseas orders have arrived.
On August 20, Kexing Zhongwei, a subsidiary of Kexing Biotech, and PT Bio Farma, a state-owned pharmaceutical company in Indonesia, signed the "Preliminary Agreement on the Purchase and Supply of New Crown Vaccine Bulk Products" and a memorandum of understanding for follow-up cooperation in Sanya, Hainan.
The agreement stipulates that Kexing Zhongwei will supply 40 million doses of semi-finished products of the new crown vaccine from November 2020 to March 2021, and has reached the intention of supplying semi-finished vaccine products for the whole year of 2021. Bio Farma will be responsible for completing the filling and packaging of the vaccine in Indonesia And supply vaccines to Indonesian people.
This is the largest order ever received by a Chinese vaccine company in public reports.
Why should Phase III clinical trials be conducted abroad?
According to Yin Weidong, the current time for the vaccine to be finally marketed depends on the results of phase III clinical trials, "if it goes well, it can be launched in November or December."
On August 11, the Phase III clinical study of Kexing Biotechnology was launched in Brazil. The planned number of people to be vaccinated is between 9,000 and 13,000. The trial is currently in progress.
After the vaccine is proven effective, the product will be registered in Brazil for use in the prevention and control of the epidemic in Brazil and the Americas.
Why are key clinical trials conducted abroad?
In this regard, Yin Weidong said that since the domestic epidemic has been effectively controlled, phase III clinical trials need to be advanced abroad to conduct larger-scale vaccine effectiveness and safety evaluations.
"Brazil has a serious epidemic, a large population, and a bigger market in the future." Yin Weidong said that countries and regions such as Indonesia, Turkey and Bangladesh are also huge potential markets for the export of domestic new crown vaccines.
"In the future, we will fully cooperate with the countries and regions where we are located, not only supplying vaccine products, but also expanding vaccine production capacity through technology transfer."
Zhang Yuntao, vice president of China Biology, said at the Public Health Forum of the Service and Trade Fair that the vaccine phase III clinical trial being promoted is a model of international cooperation against the epidemic.
"We have carried out Phase III clinical studies in 10 countries including the UAE, Jordan, Peru, Morocco, and Pakistan, and have now enrolled nearly 50,000 people."
Zhang Yuntao believes that if the domestic new crown vaccine wants to go international, it must conform to international standards and be recognized internationally.
"The phase III clinical study itself has such significance. The data of the phase I and II vaccine clinical studies are published in world-renowned journals and recognized by well-known overseas scholars. This is a miracle in the development of vaccines in China."
"In the past, some vaccine data in my country were not recognized internationally. The data on phases I and II of the new crown vaccine developed now can be recognized, which just shows the improvement of my country's overall vaccine research and development strength and level." Zhang Yuntao said that conducting clinical research overseas can help. Vaccines are compliantly going abroad as a global public health product.
Zheng Zhongwei believes that the vigorous promotion of the domestically-made new crown vaccine overseas phase III clinical trials is a reflection of global prevention and control from the height of global epidemic prevention and control.
"Our common enemy is the virus. We must break the isolation and advance the victory of the global fight against the epidemic."
The fundamental solution to the epidemic depends on vaccines, and vaccine research and development cannot do without international cooperation
At the public health forum of the Service and Trade Fair, many guests said that the fundamental solution to the epidemic will ultimately depend on vaccines, and the vaccine development process cannot be separated from global cooperation.
Only by actively carrying out international cooperation can the research and development of the new crown vaccine be promoted faster, and the rapid launch of the vaccine can be guaranteed to benefit more people.
It is reported that while Chinese vaccine companies are sharing research and development results with the world, foreign companies are also helping China fight the epidemic.
Sun Lei, head of GlaxoSmithKline's vaccine business in China, said that as the world's largest vaccine company, GlaxoSmithKline promises to produce more than 1 billion doses of adjuvants for partners in 2021 to jointly achieve the global anti-epidemic goal.
Adjuvants are ingredients added to vaccines.
On the one hand, adjuvants can improve the body’s immune response and ensure faster and longer lasting after vaccination. “The virus is very cunning, and it may have mutations. Vaccines with adjuvants may have stronger immunity to the body. Immune Network".
If the use of adjuvants can improve or even achieve a stronger protective effect while reducing the amount of antigen used, adjuvants are extremely important in the case of a pandemic.
Wang Jian, deputy director of the International Exchange and Cooperation Center of the National Health Commission, said that when all mankind is facing major public health threats, no country can stand alone.
He said frankly that in the process of international cooperation to fight the epidemic, many obstacles still need to be broken.
"For example, there are still difficulties in R&D and innovation, access supervision, production and circulation, and business models."
Gao Li, the representative of the World Health Organization in China, called for "to defeat the epidemic requires global cooperation." As an organization that coordinates the joint actions of the international community, it is hoped that countries will strengthen international cooperation in technological innovation and policy formulation, and increase investment in the public health system. Further slow down and alleviate the global impact of new coronary pneumonia.
(This article was published in China Economic Weekly, Issue 17 of 2020)
"China Economic Weekly" reporter Jia Xuan | Service Fair live report