Several h7n9 vaccines have been declared for clinical trials in China

On February 7, Shanghai Institute of new development and reproduction of infectious diseases announced that their research team has successfully developed a gene vaccine against the virus h7n9, which has entered the stage of clinical trial application However, this is not the first h7n9 vaccine to enter the clinical trial declaration stage in China Last night, a reporter from Beijing News learned that before, at least Beijing Kexing Biological Products Co., Ltd and Hualan Biological Engineering Co., Ltd had formally applied to the State Food and Drug Administration for clinical trials of their own h7n9 vaccine The State Food and drug administration has not yet approved these applications Kexing said it has prepared different types of candidate vaccine reagents On January 29 this year, Beijing Kexing company publicly said that its research team had completed the preclinical study of h7n9 vaccine and prepared different types of vaccine candidates Once approved by the State Food and drug administration, they can start clinical trials in time In March last year, a new reconstituted avian influenza virus h7n9 was first discovered in China Subsequently, the epidemic developed rapidly From March 31 to July 28 last year, 134 cases of human infection with h7n9 avian influenza were confirmed nationwide, 45 of which died About three months later, h7n9 has been "active" since December last year At present, new cases of h7n9 have been reported almost every day in Jiangsu, Zhejiang and other southeast coastal provinces The scale of h7n9 epidemic increases by 5 to 7 confirmed cases every day According to the statistics of China CDC, at present, the scale of h7n9 epidemic is increasing by 5 to 7 confirmed cases every day As early as last April, at the beginning of the outbreak of human h7n9 avian influenza, the Ministry of science and technology, together with the health and Family Planning Commission, launched the research project of human h7n9 avian influenza scientific and technological emergency prevention and control, focusing on promoting the development of clinical diagnostic reagents and vaccines At that time, the Ministry of science and technology official expected to complete the clinical verification of nucleic acid diagnostic reagents within two months, and the development of the preventive vaccine against human infection with h7n9 avian influenza within seven months At the beginning of January this year, the website of the Ministry of science and technology announced that the research and development of key technologies and products of h7n9 avian influenza virus vaccine has basically completed pre clinical research However, the completion of preclinical research does not mean that the h7n9 vaccine is on the market Industry insiders said that a new vaccine, from preclinical research to clinical trials and approval to market, still needs a lot of careful research, audit and enough time (generally 2-3 years) On the one hand, the length of this time depends on whether the vaccine development process and technical scheme are complete; on the other hand, it mainly depends on the development situation of the epidemic situation and the judgment of the government on the epidemic situation For example, "gene technology" is used for h7n9 vaccine or new production line is needed Xu said the h7n9 vaccine they developed was a genetic vaccine The reason for this process selection is that the inactivation technology does not catch a cold for H7 virus Therefore, Shanghai researchers try to implant the main pathogenic genes of h7n9 into mature vaccine carriers, which is equivalent to storing them in a safe and then putting them into human cells Since the protein structure of the virus has not been destroyed by the inactivation process, it can effectively stimulate the immune response of the human body In response, a staff member of a h7n9 vaccine research and development team in Beijing said that whether genetic engineering technology can be successfully used for h7n9 vaccine remains to be tested in practice At present, the traditional inactivation or lysis process is used in all the influenza vaccines approved for marketing in China In recent years, some foreign vaccine companies have developed new influenza vaccine by cell technology to save the time and cost of chicken embryo culture in the traditional inactivation or lysis process, but it has not been or large-scale application Beijing Kexing biology is one of the five participating teams in the h7n9 vaccine research and development project of the Ministry of science and technology Last night, Liu Peicheng, head of the marketing department of the enterprise, introduced to the reporter of Beijing news that they are applying to the State Food and Drug Administration for h7n9 vaccine for clinical trials, which is also developed by using the above-mentioned traditional technology In response to the lack of effectiveness of inactivated vaccine against h7n9, Liu Peicheng said frankly that in the previous research process, they did understand that the effectiveness of inactivated technology for some influenza viruses is not strong A typical example is that during the development of H5N1 vaccine for highly pathogenic avian influenza virus a few years ago, researchers found that compared with the traditional influenza vaccine, the dose of H5N1 inactivated virus vaccine must be very large to work However, with the increase of the dose, the risk of vaccination will naturally increase For example, initial clinical research shows that the traditional inactivated H5N1 vaccine needs to be inoculated twice a dose of 90 micrograms continuously to effectively activate the immune protection response of recipients to H5N1 Therefore, it was approved by the State Food and drug administration to produce the reserve pandemic influenza vaccine, and adopted the whole virus plus adjuvant process "In this way, 10 micrograms of two injections can make the recipients immune to H5N1," Liu said This time, the h7n9 vaccine that Beijing Kexing declared for clinical trial was developed with pandemic influenza vaccine as the prototype vaccine A person in charge of a vaccine enterprise said that genetic engineering is a new production process for influenza vaccine If the h7n9 vaccine of this process is approved for production in the future, it means that some vaccine enterprises need to start a new production line for this purpose, and also need to pass the national new GMP certification This investment is very large, and the batch needs longer time Epidemic situation New h7n9 cases in Zhejiang, Jiangsu, Guangdong and Hunan Zhejiang, Jiangsu and Guangdong health and Family Planning Commission announced Monday that one new human case of h7n9 avian influenza was found in Zhejiang and Jiangsu respectively Three new confirmed cases of human h7n9 avian influenza infection were reported in Guangzhou and Zhaoqing on July 7 Zhang XX, a 61 year old man from Xiaoshan District, Hangzhou, was diagnosed with h7n9 avian influenza on February 7 The patient is in critical condition and is treated in a hospital in Hangzhou So far, 74 human cases of h7n9 avian influenza have been reported in Zhejiang this year, and the number of reported cases is far higher than last year A new confirmed case of human h7n9 avian influenza infection and a new death case were reported by Jiangsu Provincial Department of health on the evening of August 8 Zhu, a 53 year old male, was diagnosed as a confirmed human case of h7n9 avian influenza by the Taizhou expert group on the afternoon of August 8 Before the patient became ill, he helped relatives of poultry slaughterers transport chicken feathers twice At present, the patient is treated in a hospital in Taizhou, and the condition is serious Up to now, there were 12 confirmed human cases of h7n9 avian influenza in 2014 in Jiangsu Province, and 2 cases died The reporter learned from the health and Family Planning Commission of Guangdong Province that three newly confirmed cases of h7n9 avian influenza were found in Guangzhou and Zhaoqing on July 7 At present, 58 cases have been reported in Guangdong Province, 16 cases have been cured, 12 cases have died, and 30 cases are still hospitalized in designated hospitals Hunan Provincial Department of Health announced on the evening of August 8 that a new confirmed case of human h7n9 avian influenza infection was found in Hunan Province, the seventh confirmed case in the province Case Tang XX, male, 38 years old, lives in Suining County, Shaoyang City At present, the patient is being treated in a hospital in Shaoyang.