Economic Observer Network reporter Wang Yajie On the morning of December 31, news from the press conference of the Joint Prevention and Control Mechanism of the State Council showed that at present, Sinopharm's China Bio-New Crown Inactivated Vaccine has been approved by the State Drug Administration for conditional listing.
After that, will the general public have more channels to apply for vaccination appointments on their own?
Regarding this question, a Chinese bio-related person told a reporter from Economic Observation Network that it needs to look at the opinions of the relevant disease control department, and the company does not have more information on this.
Zeng Yixin, deputy director of the National Health Commission and head of the vaccine research and development team of the Joint Prevention and Control Mechanism of the State Council, said on the same day that the next step, with the approval of conditional listing, especially with the gradual improvement of production and supply guarantee capabilities, there will be a comprehensive Vaccination of the elderly and high-risk groups with underlying diseases shall be promoted in an orderly manner, and other general populations shall be vaccinated later.
The latest statistics show that on December 15th, China has officially launched the vaccination of key populations. In the past two months, the cumulative vaccination of key populations across the country has exceeded 3 million doses.
Chen Shifei, deputy director of the National Medical Products Administration, stated that on the evening of December 30, the National Medical Products Administration had approved the registration application of the new crown virus inactivated vaccine of Sinopharm, China Bio-Beijing Company, which is conditional listing.
Statistics show that as of now, relevant departments have approved 14 vaccines to enter clinical trials, of which 5 are undergoing phase III clinical trials, including the newly announced Sinopharm Zhongsheng Beijing Company’s new coronavirus inactivated vaccine, and a number of them are in clinical trials. The previous stage of medicine is accelerating.
Protection rate 79.34%
Chen Shifei introduced that on December 23, on the basis of the preliminary rolling submission of research data, Sinopharm Zhongsheng Beijing Company formally submitted a conditional listing registration application to the Drug Evaluation Center of the State Food and Drug Administration, and the Drug Evaluation Center immediately accepted it. On the basis of the preliminary rolling review, the expert team of the Center for Drug Evaluation conducted a comprehensive and detailed review of the safety, effectiveness, and quality controllability of the research materials and data submitted by the applicant, including pharmacology, toxicology, etc. Physiological research, phase I and phase II clinical trials, phase III clinical trials carried out overseas, and the Beijing company’s large-scale production process and quality control and other pharmaceutical research data, as well as research and development activities conducted in China and domestic I, The Phase II clinical trial site was checked.
However, due to the epidemic, relevant departments cannot send professionals overseas to conduct on-site inspections of the quality of phase III clinical trials, and mainly rely on the research unit to assume the main responsibility to ensure the integrity, truthfulness and reliability of the research data. The drug inspection department also launched exploratory remote verification.
Chen Shifei said that the above-mentioned work has not been carried out before, and it has adopted a method of remote verification in view of the fact that the epidemic cannot reach the scene.
In addition, the Drug Verification Center of the National Bureau of China carried out a registered production site inspection on the production site of the Beijing company in accordance with the law, the Beijing Food and Drug Administration conducted an inspection of the quality control of drug production, and the China Institute for the Control of Pharmaceutical and Biological Products conducted a trial production of vaccine samples from the Beijing company. According to laboratory tests and quality standards review, etc., Beijing Zhongsheng Company has announced 79.34% of the vaccine protection data submitted by the applicant based on the results of the interim analysis of the large-scale double-blind placebo-controlled Phase III clinical trial. A comprehensive analysis was carried out, combined with the evaluation opinions and suggestions of the third-party expert group on the conditional listing application, and the opinions of the expert consultation meeting of the Center for Drug Evaluation. After a series of strict review, review, verification, inspection and data analysis in accordance with the law and procedures, it is concluded that the known and potential benefits of the new coronavirus inactivated vaccine of Sinopharm Zhongsheng Beijing Company are greater than the known and potential risks. , Fully meets the pre-set conditional listing standard requirements.
At present, the vaccine has reached the relevant standards of the World Health Organization and the State Food and Drug Administration. In the future, the durability and protective effect of vaccine immunization need to be continuously observed.
Xu Nanping, deputy minister of the Ministry of Science and Technology, revealed that on December 30, Beijing Institute of Biological Products Co., Ltd. announced the results of the interim analysis data of the phase III clinical trial of the new crown virus inactivated vaccine, and its protective effect reached the World Health Organization and the National Food and Drug Administration. Bureau related standard requirements. In the next step, relevant departments will continue to accelerate vaccine research and development, accelerate phase III clinical trials, provide more vaccine products with different technical routes, and at the same time pay close attention to global virus mutations and related developments, and continue to increase vaccine-related basic research.
Orderly vaccination
According to the plan, the domestic immunization planning expert advisory committee has formulated a unified vaccination plan. The relevant departments will carry out vaccination in an orderly manner, so that all eligible people can achieve "should be met" and gradually build an immune barrier for the entire population. Blocking the spread of the new crown virus will enable the new crown pneumonia epidemic to be thoroughly controlled.
Zeng Yixin said that winter and spring are the most common periods for infectious disease outbreaks. In order to prevent the outbreak of epidemics in winter and spring, but also to effectively protect cold chain logistics personnel, customs border inspection personnel, medical disease control personnel, public transportation personnel, and farmers’ markets. , Seafood market and some people with relatively high risk of infection, starting from December 15th, domestic inoculation of key populations has officially started. In the inoculation work, a series of systems have been established such as complete rules for setting up vaccination sites, strict training of vaccination personnel, screening of recipients, monitoring of adverse reactions, emergency treatment, and expert consultation for serious adverse reactions to ensure vaccination. Work is safe and smooth.
During the vaccination process, a certain proportion of adverse reactions have also occurred.
Zeng Yixin said that the main manifestations of adverse reactions include local pain and local induration. Less than 0.1% of mild fever cases, and the incidence of more serious adverse reactions such as allergic reactions is about two per million. These conditions have been dealt with in time and have been well treated.
The Economic Observer Network reporter learned that in June 2020, in accordance with the "New Coronavirus Vaccine Emergency Use Plan" approved by law and regulations, in June 2020, the relevant departments adopted the principles of small-scale start, prudence, and informed consent and voluntariness, in order to protect high-risk groups. Under the premise of monitoring of adverse reactions and preparations for emergency treatment, emergency vaccination of the new crown vaccine was carried out for high-risk groups. By the end of November, a total of more than 1.5 million doses had been vaccinated, and about 60,000 of them went to work in high-risk areas abroad. There were no reports of serious infections. The safety of the vaccine has been fully proven, and the effectiveness has been verified to a certain extent. .
It is reported that on April 2, 2020, the world’s first inactivated COVID-19 vaccine was approved to carry out phase I and phase II clinical trials. On June 23, the world’s first phase III clinical trial was launched. On June 24, it went through strict Procedures, approve emergency use in accordance with laws and regulations. Since July, a number of vaccines have successively carried out phase III clinical trials overseas.
