WestVac Biopharma's Second-Generation Recombinant Protein Vaccine Targeting Omicron and Other SARS-CoV-2 Variants Receives Approval for Phase I/II Clinical Trials in Mexico

Jul 21, 2022 10:18 CST Updated 10:18

Recently, the Mexican regulatory authority for pharmaceuticals has issued a license to approve the Phase I/II clinical trials of the recombinant variant SARS-CoV-2 vaccine (Sf9 cells) developed by Chengdu WestVac Biopharma Co., Ltd. and West China Hospital of Sichuan University. This study is a randomized, observer-blinded, controlled trial. The objective of this study is to evaluate the safety and immunogenicity of sequential booster vaccination with this product in populations who have completed primary immunization with inactivated COVID-19 vaccines, mRNA vaccines, or adenovirus-vector vaccines. The study will recruit individuals aged 18 years and older who have completed primary immunization with COVID-19 vaccines using the aforementioned technological platforms for sequential immunization clinical research. The company expects to complete the enrollment of the first cohort of subjects in the near future.

When the Omicron variant first emerged in late 2021, WestVac Biopharma swiftly initiated comprehensive research on the strain, cell substrate, and process quality of its recombinant SARS-CoV-2 variant vaccine (Sf9 cells). The subunit vaccine antigen was precisely designed based on structural insights, enabling self-assembly into stable protein nanoparticles. Large-scale vaccine production leverages advanced international insect cell protein expression technology, combined with the water-in-oil emulsion adjuvant WGa01 (an MF59-like adjuvant) to induce a more robust immune response.

Currently, the COVID-19 pandemic continues to spread globally, with the Omicron variants BA.4 and BA.5 having become the predominant circulating strains worldwide. This vaccine can induce high titers of neutralizing antibodies against Omicron subvariants such as BA.4, BA.5, and BA.2.12.1, as well as against other variants including Beta, Gamma, and Delta, suggesting that it is a broad-spectrum COVID-19 vaccine effective against multiple variants.

Currently, WestVac Biopharma has submitted applications for Phase I/II clinical trials of its recombinant variant SARS-CoV-2 vaccine (Sf9 cells) in China, Japan, and several other countries. The approval of the Phase I/II clinical trial in Mexico will further accelerate the development process of the recombinant variant SARS-CoV-2 vaccine (Sf9 cells), contributing WestVac’s strength to the global fight against the COVID-19 pandemic.