RESPONSIBILITY
Protecting Against COVID-19

COVID-19 is considered as the most widely affected global pandemic of human encounters for centuries. It is a grave crisis, a serious challenge and a war between all mankind and the virus. In facing the unexpected pandemic, as a public institute with more than 60 years of history in research and development of biological products, IMBCAMS immediately devoted itself into the research and development work of SARS-CoV-2 and its vaccines.

Taking advantages of solid basic research experience in full, IMBCAMS formed several working groups on the establishment of animal infectious model and development of vaccines from various technical routes for emergency use to carry out scientific research with mighty capacity. By utilizing the platform of the National High-level Primate Research Center, series of rigorous animal experiments were carried out on the ready primate infection model of the SARS-CoV-2 to complete the preclinical studies of the safety, immunogenicity and protective efficacy of the vaccine. The safety and efficacy of the vaccine have been preliminarily demonstrated. In parallel, the critical production process system and the quality-control standard of the vaccine were also formulated.

In May 2020, after obtaining the approval from National Medical Products Administration (NMPA), IMBCAMS launched the phase I clinical trial in the Second Huaxi Hospital of Sichuan University. The study primarily evaluated the safety, tolerance, and preliminary immunogenicity of high, medium, and low doses of SARS-CoV2 Vaccine, Inactivated (Vero Cell) in healthy subjects following a randomized, double-blinded, placebo-controlled design.

The phase II clinical trial was conducted in both Mile city and Gejiu city of Yunnan Province in June 2020. This clinical trial performed a further evaluation on the immunogenicity and the safety of the vaccine, and to determine immune schedule and immune dose.

In 2021, phase I and II clinical trials were completed, and the results showed good immunogenicity and safety of the vaccine. The multi-center phase III clinical trial is steadily progressing in Malaysia, Bangladesh, Brazil, Mexico and other countries or regions.

On May 1st of 2021, the SARS-CoV2 Vaccine, Inactivated (Vero Cell) independently developed by IMBCAMS was authorized for emergency use by China government and began to be widely employed in China.

The immunization schedule of the SARS-CoV2 Vaccine, Inactivated (Vero Cell) of IMBCAMS includes 2 doses with 2-4 weeks interval. This vaccine is eligible for adults aged 18 years and older. The annual capacity for current facility is 80 million doses. In order to meet domestic and export needs, the scale-up facility is under intensive construction and will be put into use at the beginning of 2022, when the annual capacity will be expanded to 500 to 1000 million doses.

In addition, the research of vaccines of other technical routes such as recombinant DNA vaccine and recombinant protein vaccine is also in progress. IMBCAMS will continuously make unremitting efforts for the prevention and control of COVID-19 and for the maintenance of human health and global public health security.

The latest disease control effort by IMBCAMS is focused on the COVID-19 pandemic. Based on the primate model established at the National High-level Biosafety Primate Research Center of IMBCAMS, researchers have explored the proliferation and inactivation mechanism of the SARS-CoV-2 virus and developed an inactivated vaccine candidate. The vaccine candidate has completed phase I/II/III clinical trials and been authorized for emergency use in China mainland.

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