Provincial new crown vaccine procurement catalogue published

the pace of launch of the new domestic crown vaccine seems to have accelerated again.On December 1, Jiangsu Provincial Public Resources Trading Center issued a Notice on the Procurement of New Coronavirus Vaccines (hereinafter referred to as "Notice"). The notice pointed out that in order to ensure the needs of the prevention and control of the new crown epidemic in Jiangsu Province, Jiangsu Province will carry out the procurement of three new crown vaccines.According to the procurement catalogue, the new crown vaccine purchased in Jiangsu province is a new type of coronavirus inactivated vaccine (Vero cells) that can be used urgently, from Wuhan Biological Products Research Institute Co., Ltd., Beijing Science and Technology Co., Ltd. and Beijing Biological Products Research Institute Co., Ltd.In addition, Jiangsu's upcoming procurement of new crown vaccine will also be price negotiations.

progress of vaccines included in the procurement catalogue?Public information shows that the current domestic research in the 13 new crown vaccine has entered phase III clinical trial stage, respectively, the national pharmaceutical group developed two new coronavirus inactivated vaccine, Kexing Zhongwei developed a new coronavirus inactivated vaccine, Chen Wei academician team developed a adenovirus vector vaccine and Anhui Zhifeilong Coma developed a recombinant protein vaccine.The two inactivated vaccines of the Beijing Institute of Biological Products and the Wuhan Institute of Biological Products, which are included in jiangsu's procurement catalogue, and the new crown vaccine of Beijing Koxing Zhongwei Biotechnology Co., Ltd., have entered phase III clinical trials worldwide.Liu Jingxuan, chairman of the National Pharmaceutical Group and secretary of the Party Committee, said that the two inactivated vaccines of the National Pharmaceutical Group are now in the United Arab Emirates, Bahrain, Egypt, Morocco, Peru, Argentina and other 10 countries to carry out Phase III clinical trials, has been vaccinated more than 50,000 people, a total of more than 60,000 people, the sample size of the vaccination population covers 125 nationalities.Yang Xiaoming, chairman of China Biotechnology Co., Ltd., also said that the clinical results of phase III of china's two inactivated vaccines will soon come out, and that more than 650,000 people have been urgently used, and there is no antibody-dependent enhancement (ADE). He also revealed that before the clinical use was approved in March this year, a total of 180 chinese bio-cadres were vaccinated against the new crown, and the antibodies remained in effect until the end of November.Beijing Coxing Zhongwei Biotechnology Co., Ltd.'s new crown vaccine is currently in Brazil, Indonesia and other countries in phase III clinical trials. On November 28th Yan Weidong, chairman of Koxing Holding Biotechnology Co., Ltd., said the company's new crown vaccine was expected to be completed in early December.Although no vaccine has yet been released in China Phase III clinical data, but as early as July 22 this year, in order to ensure compliance with the law, scientific safety, informed consent, voluntary vaccination, china has officially started the emergency use of the new crown vaccine, for high-exposure personnel vaccination. According to the Vaccine Management Law, in the event of a particularly serious public health event, the National Health and Safety Commission shall apply for the emergency use of the vaccine, and the State Drug Administration shall organize experts to demonstrate and agree that the National Health and Safety Commission shall make emergency use of the vaccine within a certain scope and within a certain time limit. Both inactivated vaccines and the Cossing Zhongwei inactivated vaccine, including the National Pharmaceutical Group, are included in the scope of emergency use.Jiangsu Xinguan vaccine procurement notice also mentioned "for the emergency use of epidemic prevention and control." Earlier, Liu Jingxuan, chairman of the National Pharmaceutical Group, said that the current emergency vaccination work is in accordance with the "high-risk groups, high-risk groups, ordinary people" in the order of vaccination. The CDC in Jiangsu Province has not yet responded to the applicable population for this purchase.

02 how long will it take to fully vaccinate after listing?Phase III clinical trial data is the key to marketability. The progress of Phase III clinical trials depends on the number of subjects, the speed at which the subjects were grouped, the speed at which infections were acquired in the subjects, and the results of the trials.When will China's new crown vaccine really come on the market? Wang Tao, chief reviewer of the Drug Review Center of the State Drug Administration, said that once clinical trials can obtain enough clinical research data to prove that the vaccine is sufficiently protective and has an acceptable safety basis, if its quality is also in line with the requirements, the applicant can submit a vaccine listing application at this time. The Drug Administration will, in accordance with the law and special task, complete the approval of the vaccine in the first place to ensure supply.The Measures for the Administration of Drug Registration and the Measures for the Supervision and Administration of Drug Production make it clear that disease prevention and control of much-needed vaccines and innovative vaccines may apply to the priority review and approval procedures. In August, CDE also issued guidelines for clinical evaluation of new crown vaccines.According to the guidelines, as an innovative vaccine, CDE proposes that when considering the approval of clinical evaluation criteria for listing, it needs to take into account the prevailing epidemic status, transmission capacity, prevention and treatment methods, public health needs and other comprehensive considerations.   CDE points out that current data show that people of all ages are susceptible to the new coronavirus and need mass vaccination to form a group immune barrier and block transmission. Therefore, the candidate new crown vaccine should be suitable for all ages, including pregnant and lactating women, at least for adults, including the elderly.   The guidelines require that the new crown vaccine be approved for market if it is sufficiently protective and acceptablely safe. However, even if the vaccine's mid-term analysis is well protected, conditional approval will require the completion of Phase III clinical trials.   Shi Yanyi, deputy general manager of China National Pharmaceutical Group Co., Ltd., said China National Pharmaceutical Group has submitted an application for the listing of the new crown vaccine to the State Drug Administration, Xinhua Financial reported earlier. However, as of the time of writing, the CDE website has not yet appeared in the new crown vaccine-related acceptance, on-trial records.   Apparently, the five new crown vaccines, one step away from the finish line, have made it to the final sprint.

03 Price: How to set?   "Vaccines have a public product attribute and will be priced based on cost, not supply and demand. Pricing must be within the reach of the general public. Liu jingxuan said at a press conference on joint defense control of the State Council.   Earlier, Sichuan Province has begun the procurement of new crown vaccine. Liang Zong'an, director of the Respiratory and Critical Care Medicine Department at Huaxi Hospital of Sichuan University, said the price of Sichuan's new coronary pneumonia vaccine was 200 yuan per unit.   The price in Sichuan is the same as in Zhejiang. As the first province in China to start the appointment of the new crown vaccine, Zhejiang has Jiaxing, Yiwu, Shaoxing and other places to open the new crown vaccine appointment. According to the "Shaoxing Weijian" announcement, the new crown vaccine emergency vaccination procedure for 2 doses, interval of 14-28 days, the recommended interval of 28 days, vaccination age 18-59 years old. The price of the vaccine is 200 yuan / branch (bottle), 2 doses of a total of 400 yuan, and the service fee of 28 yuan per dose.   It remains to be seen how the pricing and price negotiations in Jiangsu will go next.   Globally, Moderna's new crown vaccine program is priced at $25-$30 per unit, while bioNtech is sold to the U.S. government for $19.50 per unit. Do you think it's expensive to take a shot of the new crown vaccine 200 on Sina Weibo? Of the 32,000 people who voted, 14,000 said it was "not expensive and completely acceptable" and some people said the price was much cheaper than the cost of research and development, and even "the price of the new crown vaccine is simply cabbage compared to HPV or rabies vaccine."   It is expected that by the end of this year, the annual production capacity of China's new crown vaccine will reach 610 million doses. But as the domestic epidemic eases, it is not known how high the vaccination rate of the population will be after the new crown vaccine is released on a large scale as a self-cost vaccine. (
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