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Original title: my country has 4 new corona vaccines approved for commercialization, the scope of the vaccination population is expanding
Our reporter Meng Qingwei reports from Beijing
The number of products and technical routes of the new corona vaccine have added new members.
On February 25, the State Food and Drug Administration approved a new corona (Vero cell) inactivated vaccine andCansinoApplication for registration of a recombinant biological vaccine for new coronavirus (adenovirus type 5 vector), of which the last one is the first national new coronavirus vaccine for adenovirus vector approved in my country.
So far, four new corona vaccines have been approved in my country for conditional inclusion, including two technical routes. Prior to this, new corona vaccines from two companies, Sinopharm, China Bio-Beijing Institute, and Kexing Zhongwei, have been approved for conditional listing. This will not only further strengthen my country’s health and epidemic barrier, but will also contribute more Chinese power to the global affordability of the new crown vaccine.
Affected by this news, the relevant biological actions have experienced an increase. On February 26, the closing price of Cansino-U (688185.SH) was 485 yuan / share, which once exceeded 517.79 yuan / share in early trading.
4 products and 2 technical routes
CanSino Bio’s new corona vaccine, Keweisha, is understood to be the only new corona vaccine to utilize a single-dose immunization schedule among several new corona candidate vaccines that are at the forefront of research and development in China. Institute of Military Medicine of the Academy of Military Sciences Research and development in cooperation.
Prior to this, Kevisa conducted a global multicenter phase III clinical study in five countries, including Pakistan, Mexico, Russia, Chile and Argentina, and completed the vaccination and interim data analysis of more than 40,000 subjects.
According to CanSino Bio, Keweisha’s phase III clinical trial interim analysis results showed that 28 days after a single vaccine injection, the overall protective effect of the vaccine on all symptoms was 65.28%; 14 days after the only injection. injection, the vaccine was effective for all The overall protective effect of symptoms is 68.83%. The protective efficacy of the vaccine against serious diseases was 90.07% after 28 days of single-dose vaccination and 95.47% after 14 days of single-dose vaccination.
The “China Business Daily” reporter inquired about the relevant Kangsino Biotech disclosures and learned that the aforementioned Phase III clinical trial evaluation targets are adults 18 years of age or older.
Compared with the new inactivated corona vaccine, the adenovirus vector vaccine has the characteristics of a single dose and convenient transportation and storage.
According to the official statement from CanSino Bio, single dose vaccination can quickly achieve immune protection and shorten the vaccination cycle. This single dose vaccination program will achieve herd immunity in a shorter time. Furthermore, this vaccine uses the adenovirus vector technology pathway, which is the same as the recombinant Ebola virus disease vaccine (adenovirus vector) developed by the same technology pathway. It can be stably stored between 2 ° C and 8 ° C, making it easier to transport normally and in storage, the vaccine is more accessible.
In terms of China’s biology, according to official disclosures, Sinopharm’s Wuhan Institute of Biology of China will begin the “phase III clinical trial of new corona inactivated vaccine” in the United Arab Emirates and other countries on July 16, 2020. Interim analysis results of Phase III clinical trial show that the Wuhan Institute of Biologicals of the Wuhan Institute of Biologicals of China has good safety after vaccination. After the two-injection immunization schedule, the vaccinated individuals produced high-titer antibodies and the positive conversion rate of neutralizing antibodies was 99.06%. The new corona vaccine has been diagnosed. The protection rate of moderate to severe cases reached 100%, and the total protection effect was 72.51%, complying with the relevant standards of the relevant technical standards of the World Health Organization and the “Guidelines for the clinical evaluation of new preventive vaccines against coronavirus (trial) “issued by the State Food and Drug Administration.
The four vaccines currently on the market are divided into two technical pathways, virus-inactivated vaccines and adenovirus vector vaccines. It is understood that the three inactivated vaccines have been approved for emergency use in my country from June to July 2020, and have since been vaccinated for key populations. Sinopharm Sino Biotech and Kexing Zhongwei have received orders from several countries. For vaccination or emergency use. CanSino’s adenovirus vector vaccine also received military special drug approval in June 2020.
CanSino Bio’s Keweisha is reported to have been vaccinated in Mexico and Pakistan successively in February 2021. Outside of China, so far, China’s new Biotech crown vaccine has been vaccinated or urgently used in more than 30 countries of all the world.
Production capacity guarantee
Given the huge global demand for potential new corona vaccines, the news of the launch of two new corona vaccines in my country will undoubtedly boost global confidence in the fight against the epidemic.
Among them, in terms of inactivated vaccine production capacity, the Sinopharm China Biotech Wuhan Institute has built a new corona inactivated vaccine biosafety workshop. After inspection and certification by the relevant national departments, it has been put into large-scale production, with an annual output of 100 million doses. Previously, it was reported that the annual production capacity of Cansino New Crown Vaccine will reach 300 million doses.
In addition to the two previously approved vaccines, the reporter roughly estimated that the production capacity of the four vaccines in 2021 will reach 2.3 billion doses.
In terms of Kexing, Kexing Zhongwei has built and put into operation at the end of August 2020 the first new corona vaccine stock solution production line with an annual production capacity of 500 million doses. At present, Kexing Zhongwei has completed the construction of the second drug production line, which is expected to increase the annual production capacity of Kellyford drug to more than 1 billion doses after it is put into use in February 2021. .
In fact, from the research and development of the new corona vaccine in my country, the research and development of vaccines and the construction of production lines have progressed simultaneously. Earlier, Feng Duojia, president of the China Vaccine Industry Association, said in an interview with CCTV that my country already has 18 production lines deployed for the new corona vaccine, which can exceed 4 billion doses. by the end of 2022.
With the increase in commercialized vaccine products and the gradual expansion of production capacity, the scope of the vaccination population of my country’s new crown is also expanding, not limited to key populations. For example, Beijing is carrying out a mass vaccination to cover people aged 18 to 59.
Cui Gang, the CDC’s second-level inspector of the National Health Commission, previously stated that my country’s current vaccination strategy is to implement vaccination throughout the country according to the “two-step” plan. The first step is mainly to vaccinate some key populations, in the second step, as the vaccine is approved for conditional commercialization or the production of the vaccine gradually increases, more vaccines will be put into use. Through the orderly implementation of vaccination, eligible individuals can achieve “everything they should” and gradually build an immune barrier among the population to stop the spread of the new coronavirus in the country.
On February 18, 2021, Cai Qi, secretary of the Beijing Municipal Party Committee, pointed out during a survey conducted by the Beijing Sinopharm China Institute of Biotechnology that there is a need to strengthen biosecurity, expand vaccine production capacity and provide a strong support to fight the epidemic.
It is understood that, in order to ensure the highest degree of vaccine supply, the vaccine production workshop and the sub-packaging workshop of the China Bio-Beijing Institute are currently running at full speed.
The journalist noted that companies are also planning to industrialize vaccines that have not been approved for inclusion on the list. For example, Beijing will build an adenovirus vector vaccine factory.
In the recently announced Beijing Municipal Reform and Development Commission’s key 2021 project plan, Beijing’s Watson Innovative Vaccine Industrial Park, which Beijing plans to start building this year, will implement the industrialization of new vector corona adenovirus vaccines. and 9-valent cervical cancer HPV vaccines.
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