WestVac BioPharma Second Generation Recombinant Variant COVID-19 Vaccine Against Omicron and Other Novel Coronavirus Variants Approved for Phase I/II Clinical Trials in Mexico
2022-07-20
Recently, the Mexican drug regulatory authority issued the clinical trial approval letter for the Recombinant COVID-19 Vaccine (Sf9 cell) developed by WestVac BioPharma Co., Ltd. and West China Hospital, Sichuan University to carry out phase I/II clinical studies in Mexico. This study is a randomized, observer-blind and controlled study, aiming to evaluate the safety and immunogenicity of sequential booster vaccination in people aged 18 years and above who completed the basic immunization with inactivated COVID-19 vaccine, or mRNA vaccine, or adenovirus vaccine. The first batch of subjects will be enrolled in the study in the near future.

When the Omicron variant first appeared at the end of 2021, WestVac BioPharma took immediate actions to accelerate the research on the variants, cell matrices, and process quality of the Recombinant Variant COVID-19 Vaccine (Sf9 cell), and precisely designed the structure-based subunit vaccine antigens, which can self-assemble into stable protein particles. The vaccine is produced in scale using the internationally advanced insect cell protein expression technology combined with WGa01 (MF59-like adjuvant), an oil-in-water emulsion adjuvant that can induce a stronger immune response.
 
The COVID-19 pandemic is still spreading around the world, and the Omicron subvariants BA.4 and BA.5 have become the dominant variants worldwide. The vaccine induces high neutralizing antibody titers against the Omicron variants BA.4, BA.5, and BA.2 .12.1, as well as against Beta, Gamma, Delta, and other variants, suggesting that the vaccine is a universal COVID-19 vaccine against multiple variants.

Currently, WestVac BioPharma has submitted phase I/II clinical trial applications for Recombinant Variant COVID-19 Vaccine (Sf9 cell) in several countries, including China and Japan. The approval of the Phase I/II clinical trials in Mexico will further accelerate the development of the Recombinant Variant COVID-19 Vaccine (Sf9 cell) and contribute to the global fight against COVID-19 pandemic.