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Sinopharm, Kexing Omicron variant of new crown vaccine approved for clinical use in China
2023-01-09
On 26 April, Sinopharm China Biotech Corporation and Kexing Holdings Biotechnology Limited announced respectively that their Omicron variant strain of inactivated neocoronavirus vaccine has been granted clinical approval by China's State Drug Administration (SDA).
According to the announcement of the enterprises, Sinopharm China Biotech launched the development of Omicron inactivated vaccine on 9 December 2021 on the basis of the pre-marketed prototype strain of new coronavirus inactivated vaccine and the completion of the development of beta and delta variant inactivated vaccine. on 26 January 2022, Sinopharm China Biotech began to submit the domestic clinical declaration information on a rolling basis to the Drug Evaluation Centre of the State Drug Administration to initiate the technical review.
After Omicron began to spread globally in November 2021, Kexing Holdings Biotechnology Co., Ltd. also actively carried out the research and development of the Omicron strain of the new coronavirus vaccine. in April 2022, Kexing Holdings' inactivated vaccine against the new coronavirus based on the Omicron variant strain was granted clinical approval in the Hong Kong SAR. on 26th April, the State Drug Administration formally approved the entry into clinical studies of the inactivated vaccine against the new coronavirus based on the Omicron variant strain (Omicron) developed by Kexing Holdings. On 26 April, the State Drug Administration formally approved the new coronavirus inactivated vaccine developed by Kexing Holdings on the basis of Omicron mutant strain to enter into clinical research.
After getting the clinical approval, the inactivated vaccine still needs to go through rigorous clinical studies before it can be approved for use. Next, the two companies will conduct a randomised, double-blind, cohort study of sequential immunisation in various populations to evaluate the safety and immunogenicity of the inactivated vaccine against the Omicron variant of the new coronavirus.
