Free for all! China's first new crown vaccine conditional approval!

Pharma Network January 4th, December 31st, the State Council joint prevention and control mechanism press conference revealed that the Chinese pharmaceutical group China Bio-New Coronary Inactivated Vaccine has been approved by the State Drug Administration conditional listing.
available data show that the vaccine protection rate of 79.34 percent, to achieve safety, effectiveness, accessability, affordability, to meet the relevant standards of the World Health Organization and the National Drug Administration requirements.
follow-up, the durability and protective effects of vaccine immunization need to be continuously observed.
meeting, deputy director of the National Health And Wellness Commission, the State Council joint prevention and control mechanism of the scientific research team vaccine research and development team head Zeng Yixin said that the new coronavirus vaccine is certainly free for the whole population.
Xu Nanping, Vice Minister of Science and Technology, said that in accordance with the decision-making and deployment of the CPC Central Committee and the State Council, we have always insisted on putting vaccine research and development at the top of our priorities, as one of the five main directions of scientific research and development, and simultaneously promoted five technical routes for inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, anti-virus influenza virus vector vaccines and nucleic acid vaccines to maximize the success rate of vaccine research and development.
China has always adhered to the construction of a community of human destiny, with the United Arab Emirates, Brazil and other 16 countries to carry out international multi-center III. phase III clinical trial research, to promote China's research institutions and enterprises and countries around the world to carry out research and development and production cooperation.
always adhere to multi-party linkage, production, research and development combined, the organization of national advantage forces to carry out joint attack, research linkage, in the non-reduced procedures, do not lower standards, to ensure safety under the premise of accelerating the vaccine research and development process.
5 vaccines into Phase III. Clinical so far, China's 5 technical routes 14 vaccines have entered clinical trials, of which 3 technical routes 5 vaccines into Phase III. Chen
, deputy director of the State Drug Administration, said that after the outbreak of new crown pneumonia, the State Drug Administration has worked closely with drug regulators, including the World Health Organization and other countries, to exchange information on vaccine research and development and to coordinate safety and effective standards.
On this basis, the Drug Review Center of the State Drug Administration has formulated five standards, such as the technical guidelines for the development of vaccines for the prevention of new coronavirus, and clarified the technical standards for the application for listing and conditional approval of new coronavirus vaccines, which provides a basis for the research and development and evaluation of new coronavirus vaccines in China.
December 23rd, on the basis of the research materials submitted on a rolling basis in the previous period, The State Drug Administration's Drug Review Center formally submitted its application for registration of the new coronavirus vaccine with conditions for listing.
drug audit center is immediately accepted. On the basis of the preliminary rolling review, the team of experts of
Pharmaceutical Review Center also conducted a comprehensive and detailed examination of the research data and data submitted by the applicant on safety, effectiveness and quality control, including pharmacological, toxicology research, phase I. and PHASE II clinical trials, as well as phase III. clinical trials conducted overseas, data from pharmaceutical research such as large-scale production processes and quality control of Beijing companies, and verification of domestic research activities and domestic I. and II.
However, due to the outbreak, the State Drug Administration was unable to send professionals abroad to conduct on-site verification of the quality of Phase III. clinical trials, mainly relying on the research units to assume the main responsibility to ensure the integrity, truthfulness and reliability of the research data.
the inspection department of the drug has also carried out exploratory remote verification, which is the first time that the State Drug Administration has adopted the method of remote verification.
In addition, the Drug Verification Center of the State Drug Administration carried out on-site verification of the production site of the Beijing company in accordance with the law, the Beijing Drug Administration carried out the inspection of the quality management standards of drug production, and the China Pharmaceutical Biologics Inspection Research Institute conducted laboratory tests and quality standards review of vaccine samples tested by the Beijing company. And so on, and the applicant submitted based on large-scale double-blind placebo-controlled phase III clinical trial analysis results of the vaccine protection data - Beijing Zhongsheng Company has published 79.34 percent, carried out a comprehensive analysis, and combined with a third-party expert group on the evaluation of conditional listing applications, as well as the drug review center expert consultation meeting.
At present, the outbreak of neo-crown pneumonia is spreading around the world, the number of reported cases has exceeded 80 million, a large number of inpatients and deaths every day, the world does not yet have a special drug to treat the new coronavirus disease, China is facing the pressure of "external defense input, internal defense rebound", so in accordance with the "People's Republic of China Vaccine Law" "People's Republic of China Drug Law" and other laws and regulations, for the response to major public health emergencies in urgent need of vaccines, the national drug regulatory authorities can be conditional approval of registration applications.
, the State Drug Administration on December 30, according to law, approved the state drug Zhongsheng Beijing company's new coronavirus inactivated vaccine conditional listing.
At the same time, the State Drug Administration will urge China Pharmaceutical Group Zhongsheng Beijing Company to continue to carry out Phase III.phase clinical trials as planned in accordance with the regulations, to complete the quality and quantity of Phase III clinical trials and other conditional post-market research, according to the progress of the study and the results obtained, as well as the abnormal reactions in post-market vaccination, timely update, supplementary vaccine instructions, labels, etc., and in accordance with the provisions to the drug regulatory authorities for approval, or declaration.
Chen Said that the State Drug Administration will continue to adhere to the scientific spirit, adhere to the basic standards of safety and effectiveness, race against time to speed up the follow-up vaccine drug emergency review and approval and research and development services, to ensure that the emergency approval of vaccines and drugs are safe, effective, quality is controllable, for the final victory over the new coronavirus epidemic to make due contributions.
. At a press conference of the Joint Prevention and Control Mechanism of the State Council, the questions about the capacity of the approved new crown vaccine and whether it can cope with the mutant virus were also answered.
be released when the "latest" vaccine effectiveness data will be released? How can Chinese organisms ensure that production can supply both domestic and foreign demand? Wu Yonglin, President of China Biotechnology Co., Ltd., China Pharmaceutical Group: Thank you for your concern and concern about The New Crown Vaccine of China Biopharmaceity Group.
National Pharmaceutical Group China Bio-New Crown Vaccine in the United Arab Emirates and Bahrain and other countries conducted a large-scale Phase III. phase III clinical trials, the number of inoculations has exceeded 60,000 people, the vaccination population sample size covers 125 nationalities, completed the evaluation of phased protection rate data, the results are now better than the clinical research target, safety and effectiveness indicators exceed the World Health Organization's market standards, and our country approved conditional listing work program requirements, can form effective protection in a large population.
on December 9th and 13th, the United Arab Emirates and Bahrain, respectively, approved the official registration of the Chinese bio-neo-inactivated vaccine, a pharmaceutical group, in accordance with the relevant technical standards of the World Health Organization.
yesterday our country also approved the conditional listing of our country.
detailed data will be published at a later date, will also be published in domestic and foreign scientific research journals, please pay attention to.
thank you.
" media reports, the new coronavirus is constantly mutated, please ask whether the virus mutation will affect the protection of the vaccine effect? In addition, will this new crown vaccine, which is eligible for listing, be able to respond to the mutated virus? Xu Nanping, Vice Minister of Science and Technology: This reporter's question is very important, because the problem of virus mutation has always been a hot issue of concern to the whole society, our scientific research team is also highly concerned about this issue, from the beginning we have set up a special task force to continuously study the virus mutation.
For example, we have a database at the National Bio-Information Center that has data on nearly 300,000 new coronavirus genome sequences in more than 100 countries around the world, which we analyze every day, and now, as a whole, virus mutations occur every day, but within normal range.
As for this reporter mentioned the virus mutation on the effect of vaccine use, this is also our high concern, especially recent media reports, found in the United Kingdom some virus mutation, its spread has had a significant impact, which caused us to pay great attention to, so recently our scientific research team held a number of expert research meetings, and combined with some of our previous research results, whether the virus mutation affects the effectiveness of vaccine use of this issue has been studied in depth.
experts have found that there is no evidence that the mutations we observed have a material impact on the effectiveness of vaccine use.
But on the other hand, we also attach great importance to this problem, the long-term spread of the virus may produce some changes, for this problem, our scientific research team adopted the idea is "prefer to prepare rather than use, unavailable and unavailable."
This mutation now has no impact on vaccine use, but the future may have an impact, we take it will certainly have an impact to carry out scientific and technological work deployment, this is our basic idea, so we now have a special program, the organization of domestic strength, set up several task forces, specifically for the virus mutation, testing reagents, drug research and development, vaccine use effects, etc. , these work are being carried out.
So please believe in science, trust our scientists, we are confident that we can cope with the effects of virus mutations on the effectiveness of vaccine use, and we will certainly provide safe, effective and accessive vaccines to the general public."
thank you.
"When will China be able to achieve universal vaccination?" Deputy Director of the National Health And Wellness Commission, the State Council joint prevention and control mechanism of scientific research team vaccine research and development team leader Zeng Yixin: the eradication of infectious diseases, ultimately still rely on vaccines, so we are also planning to pass the new crown vaccine vaccination, to establish a population-wide immune barrier, and ultimately control the outbreak.
Actually, we started the emergency use of the new crown vaccine in June this year, and by December 15th we had carried out a relatively large-scale vaccination of the key population groups, which can be called the first step in the vaccination process, which is to vaccinate the key population and those at higher risk of infection.
The second step, with the approval of the vaccine conditional on the market, according to the increase in the availability of vaccine security, we will gradually expand to high-risk groups, that is, infected with the new coronavirus after the vulnerable to serious cases of this type of population vaccination, mainly the elderly and people with basic diseases.
the third step, we will expand to the whole population of vaccination.
Regarding the establishment of the immunization barrier you just asked, the proportion of people who need to be vaccinated may not be exactly the same depending on the distribution of the population in each country, but it is generally believed that it is possible to achieve a vaccination rate of 60% or even 70% in order to establish universal protection.
In view of the good safety and effectiveness of these vaccines that have been approved in our country, we are also here to advocate for people to actively participate in vaccination under the premise of informed consent and the elimination of taboos, both to protect themselves, to protect their families, to protect others, and to contribute to the prevention and control of the global epidemic."
thank you.
"What is the production capacity of China's new coronavirus vaccine?" Mao Junfeng, Head of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology: Thank you for your question.
the production capacity of China's new coronavirus vaccine, this issue is of great concern to everyone, in fact, this issue as an industrial authority, we asked ourselves to ask earlier.
Therefore, the Ministry of Industry and Information Technology, in accordance with the spirit of General Secretary Xi Jinping's important directive to promote the organic convergence of the new coronavirus vaccine research and development and industrialization chain, has been closely tracking the progress of vaccine research and development and accelerating the process of vaccine industrialization.
To this end, we have set up a special class for the production and protection of the new coronavirus vaccine, weekly scheduling of key enterprises production capacity construction progress, the organization of relevant provinces and cities of the ministry of industry and information technology to arrange for special people to docking and service enterprises, to promote the various technical routes of enterprises to speed up production capacity construction.
At the same time, we have also made a comprehensive combing of the entire industrial chain and supply chain of the new coronavirus vaccine, guiding enterprises to seriously analyze and analyze the supply risks of key raw materials, key equipment and supplies and other important production materials, do a good job of upstream and downstream supply and demand docking, to ensure the stability of the supply chain of the new coronavirus vaccine production.
according to the scheduling situation, there are currently 18 enterprises in China, according to their new coronavirus vaccine research and development progress, has carried out production capacity construction.
So far, three enterprises, China National Pharmaceutical Co., Ltd. Beijing, China National Pharmaceutical Co., Ltd. Wuhan Co., Ltd., and Beijing Coxing Zhongwei Co., Ltd., have completed this year's production capacity construction tasks, and their production workshop with high biosecurity level of the new coronavirus inactivated vaccine has passed the biosecurity acceptance of multi-sectoral joint organizations.
inactivated vaccine, especially from Chinese medicine company Zhongsheng Beijing, was approved for conditional listing yesterday.
, Zhongsheng Beijing has also started large-scale production.
these enterprises to carry out large-scale production, we are also organizing them to carry out simultaneous and parallel capacity expansion work.
, the reporter's concern about capacity is actually a dynamic and continuous process of improvement.
other technical routes, capacity building is also in accordance with the plan to advance in an orderly manner.
So, with the further improvement of the production capacity of the new crown inactivated vaccine, and the gradual completion of the production capacity route of other technical route enterprises, I believe, I also ask you to believe that the production capacity of China's new crown virus vaccine can meet the domestic demand for mass vaccination.
Next, the Ministry of Industry and Information Technology will, in accordance with the decision-making and deployment of the CPC Central Committee and the State Council, strengthen coordination and coordination with relevant departments to form a policy joint effort to further promote production capacity, ensure the smooth supply chain of vaccine production, and comprehensively do a good job in organizing and safeguarding the large-scale production of new coronavirus vaccines.
thank you.
"How long will the antibodies provided by this approved conditional new crown vaccine last and how long will the effective performance last?" Wu Yonglin: Thank you for your question.
Chinese Pharmaceutical Group conducted phase I., II. clinical studies in China, and phase III. clinical studies conducted abroad, all carried out continuous observation of antibodies.
, antibodies can remain at higher levels for more than six months, according to data from the New Coronary Inactivated Vaccines I. and II.
just now, I also said that the United Arab Emirates, Bahrain in accordance with the relevant technical standards of the World Health Organization, approved the national pharmaceutical group China Bio-New Crown Vaccine officially registered for listing.
results from clinical trials show that the protective data results meet the target and meet the requirements for listing.
, china, the United Arab Emirates, Bahrain and other countries of clinical research is still ongoing, will continue to observe the holding of antibodies