Clinical Trial Approval Issued for Coviccine® II—Recombinant COVID-19 Vaccine against Variants including Omicron by NMPA
2023-01-20
Following the approval of Coviccine®—Recombinant COVID-19 Vaccine (Sf9 Cell) developed by WestVac Biopharma Co., Ltd./West China Hospital of Sichuan University for emergency use by the national authority, WestVac Biopharma/West China Hospital of Sichuan University have again made significant progress in the development of COVID-19 vaccine!
On January 20, 2023, Recombinant Variant COVID-19 Vaccine (Sf9 cell) against the latest prevalent variants including Omicron received the Approval for Clinical Trial by the National Medical Products Administration of China, the phase I/II clinical trials will soon begin. The phase I clinical trial will evaluate the safety, tolerability and immunogenicity of the vaccine in (i) Individuals aged 18 years and above who have not received the COVID-19 vaccine, (ii) those who have been infected with COVID-19 for 3 months or more, (iii) people who have completed 3 doses of inactivated COVID-19 vaccine for 3 months or more. The phase II clinical trial will evaluate the safety and immunogenicity of the vaccine as a booster dose in healthy individuals aged 18 years and above who have completed 2 or 3 doses of inactivated COVID-19 vaccine. WestVac Biopharma will soon start recruiting the first batch of subjects.
In response to the Omicron variant’s emergence, WestVac Biopharma acted swiftly and took the initiative to investigate the variants, the cell substrate and the process quality of Recombinant Variant COVID-19 Vaccine (Sf9 cell) against the variant. Recombinant Variant COVID-19 Vaccine (Sf9 cell) is an entirely synthetic vaccine. The subunit vaccine antigen is precisely designed based on the structure of the targeting S-RBD protein of the COVID-19 variant and can self-assemble into stable trimeric protein particles. The internationally advanced insect cell expression technology is adopted for the mass production with the oil-in-water emulsified adjuvant WGa01 (MF59-like adjuvant) developed by WestGene Biopharma Co., Ltd. which can induce stronger immune response.
At present, COVID-19 is still spreading around the world, and the Omicron subvariants BA.4, BA.5, BF.7, BQ.1 and XBB have become the most prevalent variants. Animal studies on the safety and immunogenicity of Recombinant Variant COVID-19 Vaccine (Sf9 cell) revealed that the vaccine induced high titers of neutralizing antibodies in animals such as mice and monkeys, and over 10,000 neutralizing antibodies that can completely suppress the live virus of the prevalent Omicron subvariants, indicating that the vaccine is a universal COVID-19 vaccine effective against multiple strains.
The Mexican drug authority has approved Recombinant Variant COVID-19 Vaccine (Sf9 cell) for phase I/II clinical trials in July 2022. In the meantime, WestVac has submitted the application for Recombinant Variant COVID-19 Vaccine (Sf9 cell) phase I/II clinical trials in other countries including Japan. The approval of the phase I/II clinical trials in China will accelerate the development of the vaccine and contribute to the fight against COVID-19!
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WestVac Biopharma Co., Ltd. (WestVac Biopharma) is an innovative biopharmaceutical company integrating vaccine R&D, production and sales. From 2021 to 2022, WestVac Biopharma was selected successfully on the list of unicorn companies for two consecutive years. WestVac Biopharma has a mature insect cell expression platform, bacterial vaccine platform, mRNA vaccine platform, novel adjuvant platform, tumor vaccine and immunotherapy platform, as well as over 20 pipelines that include COVID-19 vaccine, multivalent influenza vaccine, herpes virus vaccine, tumor immunotherapy agents. The company has brought in top-tier talent from well-known Chinese and multinational vaccine companies, and a well-equipped production and quality management system. With more than 300 employees in Chengdu Tianfu International Bio-town, WestVac Biopharma has established a production base with an annual production capacity of 600 million doses of vaccine. The production line was constructed and verified in accordance with GMP guidelines and was granted the “Drug Manufacturing License”. In addition, the Guangzhou production base is also under construction. Coviccine® --Recombinant COVID-19 Vaccine (Sf9 cell) has been approved by the national authority for emergency use. As of mid-January 2023, Coviccine® has been in the bidding process and sent for vaccination in 8 provinces including Sichuan and Yunnan.
