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World's first! China Biological Beijing and Wuhan Institute of Biological Products Receive Hong Kong Clinical Approval for Two Omicron Inactivated Vaccines
2023-01-09
Recently, two new inactivated coronavirus vaccines (Omicron variant, hereinafter referred to as "O-strain") developed by Sinopharm's China Biologicals Beijing Bioproducts Research Institute and Wuhan Bioproducts Research Institute have been approved by the Research Ethics Committee of the University of Hong Kong and Hong Kong Island West Hospital of the Hospital Authority, as well as by the Clinical Trial Approval from the Pharmacy and Poisons Board of Hong Kong, and have been formally authorised to carry out a sequential immunisation clinical study of the new coronavirus vaccines in Hong Kong.
Since the outbreak of Omicron variant, China Biological immediately organised a research team to initiate the research and development of vaccines against Omicron strain. Beijing Institute of Biological Products (BIBP) and Wuhan Institute of Biological Products (WIBP), both of which are affiliated to China Biotechnology, have made all-out efforts to carry out scientific research and developed BIBP-New Inactivated Coronavirus Vaccine (O Strain) and WIBP-New Inactivated Coronavirus Vaccine (O Strain). Both of them are made by inoculating Vero cells with the Omicron strain, and then cultured, inactivated, purified, and adsorbed with aluminium hydroxide adjuvant. The vaccine is made by inoculation of Omicron strain into Vero cells, culture, activation, purification and adsorption with aluminium hydroxide adjuvant.
After the successful development of the vaccines, China Biological actively cooperated with the University of Hong Kong and submitted the ethical application and clinical trial application to the Hong Kong Research Centre in the first instance, and successfully obtained the ethical approval and clinical approval on 12 April and 13 April respectively.
As the next step, China Biotech will conduct a sequential immunisation clinical study in the form of a randomised, double-blind, cohort study in people aged 18 years and above who have completed 2 or 3 doses of the new coronary vaccine to evaluate the safety and immunogenicity of the two vaccines, namely, BIBP-New Inactivated Coronary Virus Vaccine (O Strain) and WIBP-New Inactivated Coronary Virus Vaccine (O Strain).
China Biological will actively and efficiently push forward the clinical trial of the Omicron strain of the new coronavirus vaccine, and will do its utmost to complete the clinical trial as soon as possible and put the vaccine into use, so as to make a new contribution to the victory over the new coronavirus epidemic and safeguard the public health safety of mankind.
