“Hopefully, by 2021, 2 billion doses of vaccine will be produced. Sumia Swaminathan, WHO’s chief scientist, said one or two successful vaccine candidates could emerge by the end of the year. Fortunately, she says, the new coronavirus appears to have mutated much less than the flu virus, and key parts such as the severity of the disease and the immune response have not yet shown a mutation.
At least 200 new crown vaccines are currently being developed, and about 10 have entered human trials, three of which will soon be in Phase III clinical trials, including those from China.
On June 16th, a clinical trial of the new crown virus inactivated vaccine, Phase I/II, developed by the Wuhan Biological Products Research Institute in China, was unveiled, and the results showed that:
Vaccination group inoculated people all produced high titer antibodies;
No one had any serious adverse reactions;
18-59 age group 0, 28-day procedure inoculated with two doses and antibody impotence rate of 100%.
Inactivated vaccines are vaccines that will render the virus infectious and replicable through physical or chemical treatment, but retain the activity of the virus that causes the human immune response.
However, because the protein shell of the virus is easily degraded in the human body, it is usually required to be vaccinated multiple times, the demand for vaccines is high.
According to Chinese biologicals, initial clinical trials of the new crown inactivated vaccine began on April 12 and took 66 days.
The results are based on different ages, different procedures, different doses, different needle tests, which is also the longest, most comprehensive data, the most effective clinical research results of the new crown vaccine.
Chinese Biology pointed out that the phase I/II clinical study was mainly aimed at assessing the safety and immunogenicity of the new crown inactivated vaccine.
This clinical trial was a randomized, double-blind, placebo-parallel-controlled Phase I/II clinical trial in 1120 healthy subjects aged 18-59, with a focus on cellular immune changes after vaccination, in low, medium, high doses and 0,14, 0, 21, and 0,28 different procedures.
After all the subjects completed 2 injections, the researchers explored trends in vaccination immunization procedures, immunization doses, safety, immunogenicity, and in vivo antibody levels.
The results showed that the subjects in the vaccination group all produced high titer antibodies. Among them, the dose in the 18-59 age group was 97.6% neutralized after two doses of the program, and the antibody impotence rate was 100% after two doses were given in the 0,28-day procedure.
In other words, from the current research results, China’s new bio-crown inactivated vaccination is safe and effective.
However, clinical trials are not yet complete.
In addition to vaccines, according to the National Health and Health Commission website 18 news, the National Health and Health Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the State Administration of Market Supervision, the State Drug Administration five ministries jointly issued the “universal requirements for biosecurity in the vaccine production workshop”, as a temporary emergency standard to promote the production of new crown vaccines.
On the issuance of the “vaccine production workshop biosafety common requirements notice” policy interpretation: safe and effective vaccine is an important guarantee to prevent and control the outbreak of new crown pneumonia. The use of pathogenic microorganisms for vaccine production has a certain biological safety risk, and it is necessary to ensure the quality of the vaccine while ensuring the biosecurity of production activities.
Therefore, in order to promote the research and development and production of the new crown vaccine, in accordance with the State Council to deal with the new coronavirus infection of the pneumonia outbreak joint prevention and control mechanism deployment, the National Health and Health Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the State Administration of Market Supervision, the State Drug Administration and other five ministries jointly issued the “universal requirements for biosecurity in the vaccine production workshop.”
This document refers to the laws and regulations and standards related to biosecurity at home and abroad, closely integrates with the requirements of the quality management specifications for pharmaceutical production, and puts forward biosecurity requirements based on the biosecurity risks in the whole process of vaccine production.
The first is to grade the level of protection in the vaccine production workshop.
The second is the provision for low/high biosecurity risks workshop, its production workshop and facilities, production equipment, verification and evaluation should be in accordance with the low/high biosecurity related requirements.
Third, the biosecurity put forward clear requirements and measures. Fourth, the organization and personnel, document management, security management, security control and continuous improvement, such as the provisions and requirements.
During the prevention and control of the new crown pneumonia outbreak, this document, as a temporary emergency standard to promote the production of the new crown vaccine, only stipulates the biosecurity requirements of the new crown vaccine production workshop, and other construction, management and operation must meet the relevant requirements of national laws and regulations and standards.
This notice shall be in effect from the date of issuance.