Recently, there has been frequent news about the development and application of COVID-19 vaccines. In particular, the mRNA vaccine jointly developed by Bayerntech and Pfizer has been announced to be 90% effective. The COVID-19 vaccine jointly developed by AstraZeneca and Oxford University is effective. The ratio reached 70%, triggering changes in overseas capital markets. So why has there been no data release for the domestically produced COVID-19 vaccine that has already entered Phase III clinical trials?

Chinese companies are rigorous in the research and development of new crown vaccines

Tao Lina, a former vaccine expert at the Shanghai Centers for Disease Control and Prevention, said in an interview with a reporter from Securities Daily that although China’s independently developed new crown vaccine has not No clinical trial data has been released, but some emergency use situations have been announced. For example, the chairman of Sinopharm said that it has been used on nearly one million people, and there has been no report of serious adverse reactions, only some minor symptoms. .

Tao Lina said: "Since vaccine clinical practice is a very rigorous scientific experiment, China's new crown vaccine may be announced through papers and other forms, so it will take more time. Effectiveness information of foreign new crown vaccines It was announced to the media by the R&D companies and was not presented in the form of a paper, so it is not rigorous enough from a scientific perspective. The late announcement of China's COVID-19 vaccine development progress also shows that we are more cautious about it, especially China's COVID-19 vaccine. Phase III clinical trials are all conducted abroad, and there are many uncontrollable factors. "

Not long ago, the authoritative medical journal "The Lancet" published a peer review paper on Chinese vaccines, arguing that China Sinovac Biotech. The new coronavirus vaccine developed can quickly induce an immune response within 4 weeks and is suitable for use during a pandemic. The article stated that to determine whether the immune response triggered by China's new coronavirus vaccine can protect people from infection, the results of large-scale late-stage trials, namely phase III clinical trials, are particularly important, and the duration of the antibody response must be studied in the future.

Currently, China has four new coronavirus vaccines undergoing Phase III clinical trials in more than ten countries around the world, including two inactivated vaccines from Sinopharm, an inactivated vaccine from Sinovac, CanSino and Chenwei An adenovirus vector vaccine jointly developed by academicians. Some of these vaccines have completed mass production, and countries such as Türkiye have begun negotiating reservations. Domestic provinces such as Sichuan have begun the procurement of domestically produced COVID-19 vaccines, and the price of the introduced Sinovac COVID-19 vaccine is 200 yuan/tube.

Tao Lina believes that there have been no reports of serious adverse reactions among the subjects of the new coronavirus vaccine independently developed by China, which proves the effectiveness of the domestic new coronavirus vaccine to a certain extent. The next step is to wait for a blockbuster vaccine time.

Promote the upgrade of China's vaccine research and development

According to data released by market research organization EvaluatePharma, the global vaccine market size in 2019 was approximately US$32.5 billion, ranking fourth among all treatment fields. The market share is approximately 3.6%. The global vaccine market has formed an oligopoly competition pattern. In 2019, the vaccine business of the four major vaccine giants GlaxoSmithKline (GSK), Merck, Pfizer and Sanofi achieved revenue of US$8.481 billion, US$7.967 billion, and US$6.716 billion respectively. , 6.504 billion U.S. dollars, accounting for more than 90% of the global vaccine market.

Unlike the high concentration of the global vaccine market, since my country's vaccine industry has only been market-oriented for more than 20 years, the vaccine market structure is relatively fragmented. According to incomplete statistics, my country currently has more than 300 domestic vaccine approvals and more than 50 vaccine companies. China National Biotec Co., Ltd., a subsidiary of Sinopharm Group, is the leading domestic vaccine company with subsidiaries in Beijing, Shanghai, Wuhan, Chengdu, Changchun, Lanzhou, etc. The Institute of Biological Products holds more than half of the vaccine approval documents.

In recent years, China's independently developed vaccine products have been launched one after another, and R&D investment has increased year by year. In 2020, Xiamen Wantai Canghai bivalent human papillomavirus vaccine, Watson Biotech 13-valent pneumococcal polysaccharide conjugate vaccine, and Changchun 100g nasal spray influenza vaccine were approved for marketing, launching an impact on the monopoly of international vaccine companies. According to statistics from a reporter from Securities Daily, among the 55 listed companies in the Oriental Fortune Biological Vaccine sector, 46 companies saw a year-on-year increase in R&D expenses in 2019, and 38 companies reported a year-on-year increase in R&D expenses in their 2020 semi-annual reports.

Wang Ruiyan, a medical researcher at China Fortune Land Development Research Institute, told a reporter from Securities Daily that although the clinical trials of vaccines by Chinese biopharmaceutical companies have increased significantly in recent years, just like the relationship between original drugs and generic drugs, the research and development of many domestic vaccines They are imitating Western products, and only a few vaccines such as HPV (human papillomavirus) have independent intellectual property rights.

There are great constraints on the development of the vaccine industry. On the one hand, the research and development cycle of vaccine products is long and the investment cost is high. The entire process from concept to launch of innovative vaccines generally takes 8 to 12 years; on the other hand, large-scale industrialization There are certain difficulties. The vaccine industry has high quality control requirements and requires control of the entire production process. This poses technical and scale difficulties for Chinese biopharmaceutical companies in the development stage.

The research and development of the new coronavirus vaccine has broken down this barrier. Provinces and cities have actively launched vaccine research and development base projects this year. For example, in May this year, Ruike Biotech cooperated with the Jiangsu Provincial Center for Disease Control and Prevention and Taizhou Medical Park to launch the first recombinant COVID-19 vaccine research and development project in the province.