Jia Xuan, a reporter from China Economic Weekly
The pace of domestic COVID-19 vaccine research and development for the Omicron variant is accelerating.
On April 26, the State Drug Administration officially approved the entry of two inactivated vaccines of the new coronavirus (hereinafter referred to as "Ao strain vaccine") based on the mutated new coronavirus Olmi kerong strain into clinical research to evaluate the safety and immunogenicity of the vaccine in various populations. The two vaccines are from Sinopharm Group China Biotechnology Co., Ltd. (hereinafter referred to as "China Biotech") and Kexing Holding Biotechnology Co., Ltd. (hereinafter referred to as "Kexing").
Affected by this news, under the background of the decline in the broader market on the same day, Sinopharm (600511.SH) rose sharply. Sinopharm Consistency (000028.SZ), Sinopharm Modern (600420.SH) and so on followed the rise.
As of April 27, 8 new crown vaccine concept stocks have issued the first quarter of this year's performance report or performance forecast, according to the report data or the lower limit of the forecast data, all of them have achieved profitability. Among them, the net profit attributable to the mother in the first quarter of Zhifei Biology and Wantai Biology exceeded 1 billion yuan. At the same time, northbound funds are optimistic about the concept stock of the new crown vaccine in the near future.
Sinopharm China Biological Aomi Kerong Variant New Coronavirus Inactivated Vaccine (Source: Sinopharm China Biological Public Name)
Kohin Aomi Kerong variant strain new coronavirus inactivated vaccine (Source: Enterprise Photo)
Omikeron has a strong spread and has undergone many mutations
In November 2021, Omi kerong began to spread globally. On the evening of December 13, the Tianjin Municipal Health Commission reported that Tianjin had detected the new coronavirus Omilon variant from the inbound personnel, which was the first detection of the Chinese mainland.
Two days later, on December 15, 2021, the World Health Organization (WHO) issued a tip that prima facie evidence suggested that the Omiljun strain may have weakened the effectiveness of the COVID-19 vaccine and that people are at higher risk of repeat infection with the strain. A month later, the group again suggested that by analyzing 357206 samples of viral gene sequences collected around the world over the past 30 days, it was clear that the Omiljun strain was rapidly replacing other strains as the main circulating strains.
Unlike the previous generation of new coronavirus Delta, the most prominent feature of Omi kerong is its strong transmission. Liang Wannian, head of the expert group of the National Health Commission's Leading Group for Epidemic Response and Handling, has publicly stated that in the absence of protective measures, an average of 9.5 people can be transmitted by 1 patient of Omi kerong.
In addition, Omirkjong is unpredictable. In just over 5 months since the strain was discovered in November 2021, Omikeron has mutated from BA.1 to BA.2 and then to XE. XE is not fully dominant, and ba.4 and BA.5 are now emerging. According to research, XE is a combination of the Opichron variants BA.1 and BA.2, and BA.4 is a reorganization between BA.1 and BA.3.
At the press conference on the prevention and control of the new crown pneumonia epidemic held in Zhejiang Province on April 28, Sun Liming, deputy director of the Provincial Health Commission, reported that the main strain of the current round of epidemic in Zhejiang is Omicron BA.2, which spreads faster than the past mutant strains, has a strong infectivity, a short incubation period, and the average time of passage has been shortened from 1 week of the early virus to 2-3 days, and it is highly insidious. In the case of undetected, 2-3 generations can be passed on within a week, or even one generation per day.
It is worth noting that due to the strong concealment of Omi kerong, some people are neglecting to take precautions, and even the misunderstanding that Omilon is a "big flu". In this regard, Liang Wannian said that real-world data show that the average case fatality rate of Aumechjong is about 0.75%, which is 7 to 8 times that of influenza. The case fatality rate of the elderly, especially those over 80 years old, exceeds 10%, which is nearly 100 times that of ordinary influenza.
In the face of the menacing Aomi Kerong, the rapid development and issuance of targeted vaccines has become the key to fighting the "epidemic".
Clinical studies take 3-4 months
The reporter combed the research and development progress of China Biologics and Kexing and found that the research and development of the Austrian vaccine is not only a race against time, but also a competition between peers.
According to the public information of the two companies, when the Aomikron strain was not detected in the Chinese mainland last year, Kexing obtained a nasopharyngeal swab sample of the infected person with the Austrian strain on December 5 last year, and cooperated with the team of Professor Qin Chuan of the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences to carry out virus isolation and whole gene sequencing. Four days later, Coshing introduced samples of Olympus strains isolated from the University of Hong Kong. On the same day, China Biologics also quickly launched the research and development of an inactivated vaccine for Aobu.
Since the end of January 2022, China Biologics and Kexing have successively submitted domestic clinical declaration materials to the Drug Evaluation Center (CDE) of the State Food and Drug Administration on a rolling basis and initiated technical review. On April 13, China Biologics received clinical research approval from the Hong Kong Department of Health, becoming the world's first inactivated vaccine approved to enter the clinic. The next day, the Cosyo vaccine was followed by the same approval. On April 26, the State Drug Administration simultaneously approved two companies to enter clinical research.
At present, China Biologics is accelerating the relevant clinical research work. Next, sequential immunomic clinical studies will be conducted in the form of randomized, double-blind, cohort studies in people aged 18 years and older who have completed 2 or 3 doses of COVID-19 vaccination to evaluate the safety and immunogenicity of the Omiljung variant inactivated vaccine for the new crown virus.
Kexing said that it will continue to carry out extensive cooperation with global partners to actively promote the study of various strains of the new crown virus in different populations of prototype vaccines, as well as the sequential vaccination of the new crown vaccine prepared by the variants.
In view of the relevant situation of the Austrian vaccine, at the media communication meeting organized by China Biologics on April 27, Zhang Yuntao, chief scientist and vice president of the company, and Yang Huichuan answered the questions.
"The Ao strain vaccine is not a complete negation of the previous new crown vaccine, and the generation of new crown vaccines vaccinated in the early stage is still effective, especially for the prevention of severe illness and death for people over 60 years old, which has obvious efficacy." Zhang Yuntao stressed that the current vaccination of the Olympic vaccine, from the perspective of clinical design, is not designed according to four injections, but on the basis of the completion of two or three injections of inactivated vaccine in the early stage, the vaccination research is carried out.
For the issue of whether the elderly and children can be vaccinated with the Austrian strain vaccine, Zhang Yuntao said that the current clinical research will be carried out first for people over 18 years old, and follow-up clinical research will be accelerated for people aged 3 to 17 years old and infants and young children. Once the data are available, this subset of the population can also be vaccinated.
"The contraindications to the Ao-strain vaccine and the contraindications to the first-generation inactivated vaccine are completely consistent, and there are no other special matters. Corresponding clinical studies have been carried out for diabetes, hypertension, AIDS and other populations, and the contraindications will gradually decrease in the future. Zhang Yuntao said.
Speaking of the production of Aomi Kerong's inactivated COVID-19 vaccine, Yang Huichuan said that since the epidemic, China Biologics has launched the research and development of new crown vaccines and workshop construction, and built 3 P3 high-grade biosafety laboratories and 6 P3 high-grade bio-safety production workshops across the country, with an annual production capacity of more than 7 billion doses. These production facilities originally built by China Biotech, including the supporting sub-packaging, can be continued to be used in the production of Austrian vaccines.
As for when the Aoduline vaccine will be available, Zhang Yuntao said: "At present, clinical research in Hong Kong and Chinese mainland, China, should take about 3 months to 4 months to complete. ”
Editor-in-charge: Yang Lin
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