Events
On April 26, the inactivated covid-19 virus vaccine of Sinopharm China biological Omicron variant (Austrian strain) was approved by the State Food and drug administration.
Commentary
The inactivated vaccine of Zhongsheng Austrian strain became the first inactivated vaccine of Omicron strain approved for clinical use in the world, and the animal experiment results were good. Sinopharm China Bio launched the research and development of inactivated vaccine of Austrian strain on December 9, 2021 on the basis of the research and development of inactivated vaccine of covid-19 prototype strain and inactivated vaccine of beta and delta mutant strain that have been listed in the early stage. On April 13, the clinical research approval was obtained from Hong Kong, China. According to the guiding principles and R & D strategy of the improved covid-19 vaccine of the State Food and drug administration, Sinopharm China bioavailability’s new P3 high-level biosafety laboratory has completed the screening, passage and amplification of Austrian virus species, established a three-level virus seed bank, and completed process verification, preparation of multiple batches of large-scale products, quality standard research, in vivo safety evaluation of animals and immunogenicity research, The results showed that Austrian covid-19 inactivated vaccine could produce high titer neutralizing antibodies against Austrian strain and many variants.
The clinical trial was a randomized, double-blind and cohort study. In the form of randomized, double-blind and cohort study, China biology will conduct a sequential immune clinical study among people aged 18 and over who have completed 2 or 3 doses of covid-19 vaccine to evaluate the safety and immunogenicity of inactivated covid-19 virus vaccine of Omicron variant.
The research and development progress of variant vaccine in various technical paths in China continues to make breakthroughs, and pay attention to the follow-up clinical progress. Since April, the mRNA covid-19 vaccine developed by Shijiazhuang Pharmaceutical Group and Cansino Biologics Inc(688185) biology for mutant strains has been approved by the State Food and drug administration to carry out clinical trials. Anhui Anke Biotechnology (Group)Co.Ltd(300009) and Hefei afana biology have reached strategic cooperation and carried out exclusive cooperation on preclinical research, clinical research, industrialization and marketing of “covid-19 Omicron and other mutant mRNA vaccines”. The project has completed pharmaceutical and pharmacodynamic research, Safety evaluation experiments are being carried out and relevant clinical trial application materials are being sorted out.
China’s sequential vaccination is advancing in an orderly manner, and anti epidemic means are expected to continue to be enriched. According to the data released by the joint prevention and control mechanism of the State Council, as of April 18, the country had reported 3.32 billion doses of covid-19 vaccine, with a total number of 1.28 billion people, and 1.25 billion people had been vaccinated in the whole process. The number of people covered and vaccinated in the whole process accounted for 90.94% and 88.43% of the total population of the country respectively. 730 million people were vaccinated, including 25.426 million people who were vaccinated sequentially. At present, the epidemic situation in some areas has been repeated. If the research and development of inactivated vaccine of Austrian strain has made positive progress, it is expected to help China fight the epidemic.
Investment advice
We are optimistic about the future potential of the new covid-19 vaccine developed for mutant strains. Covid-19 vaccination is the most economical, effective and safest way to prevent and control covid-19 pneumonia. It is recommended to continue to pay attention to the research and development progress of covid-19 vaccine industry and companies in relevant fields, Chongqing Zhifei Biological Products Co.Ltd(300122) , Cansino Biologics Inc(688185) biology, stone Pharmaceutical Group, Walvax Biotechnology Co.Ltd(300142) , Shenzhen Kangtai Biological Products Co.Ltd(300601) , etc.
Risk tips
R & D fails or R & D progress does not meet expectations; Risk of adverse reactions; Covid-19 strain mutation risk; Intensified market competition; Independent and controllable risks of the supply chain.
