The stage of vaccine research and development includes three stages.

Vaccine research and development includes three stages: laboratory development, preclinical research and phase III clinical research.

The specific process of vaccine development is as follows:

Vaccine refers to biological products made of various pathogenic microorganisms for preventive inoculation. Vaccines made from bacteria or spirochetes are also called vaccines. Vaccines are divided into live vaccines and dead vaccines. Commonly used live vaccines include BCG, polio vaccine, measles vaccine and plague vaccine. Commonly used dead vaccines include pertussis vaccine, typhoid vaccine, meningococcal vaccine and cholera vaccine.

There is more than one vaccine in China. Take COVID-19 Vaccine as an example, it was developed by Beijing Institute of Biological Products, which is affiliated to China Biological of Sinopharm Group.

On August 5, 2020, the COVID-19 Inactivated Vaccine Production Workshop of Beijing Institute of Biological Products, affiliated to China Biological of Sinopharm Group, passed the joint biosafety inspection organized by relevant state departments and was qualified for use. Previously, the workshop had obtained the vaccine production license of COVID-19.

On June 5438+February 3, 2020, the joint prevention and control mechanism of the State Council released that the COVID-19 inactivated vaccine of Sinopharm Group China Bio has been conditionally listed in the State Pharmaceutical Administration, and the protection effect meets the requirements of the relevant standards of the World Health Organization and the State Pharmaceutical Administration, and will be provided free of charge to the whole people in the future. Up to 20021120, more than150,000 people have been vaccinated in China.

Vaccine clinical research is generally divided into three stages, namely: stage I mainly evaluates safety and a small number of volunteers; The second stage is to expand the population to assess safety, and at the same time explore vaccine dosage and immunization procedures, ranging from hundreds of people; In the third phase, the effectiveness of the vaccine in the target population was confirmed and the safety was observed. The number of people participating in the clinical trial was determined by the incidence rate and the expected curative effect level of the vaccine.

Simply put, vaccines must be safe, effective and controllable in quality. The research and development of vaccine needs to verify its effectiveness and safety, and the safety inspection needs a long period, so the research and development period of general vaccine will not be less than one and a half years.