Dialogue with Beijing New Crown Inactivated Vaccine Development Enterprise: The vaccine passed the inspection by the Chinese Procuratorate, and the first batch of volunteers completed the first vaccination
New Crown Vaccine Rapidly Promotes Standards and Does Not Reduce Procedures
On April 16th, in Suining County, Xuzhou City, Jiangsu Province, the staff demonstrated the first clinically inactivated new coronavirus vaccine. Photo by Wang Chunhui
Since the outbreak of New Coronary Pneumonia, the progress of vaccine research and development has been receiving much attention. New coronavirus is a new pathogen. The vaccine development is more difficult and the cycle is relatively long. In order to ensure the success of early research and development, China's scientific research team has deployed 5 vaccine development technology routes, including virus inactivated vaccine, nucleic acid vaccine, recombinant protein vaccine , Adenovirus vector vaccine and attenuated influenza virus vector vaccine.
On April 14, at the press conference of Beijing New Coronavirus Pneumonia Prevention and Control, Xu Qiang, director of Beijing Municipal Science and Technology Commission, introduced Beijing Kexing Zhongwei Biotechnology Co., Ltd. (hereinafter referred to as Kexing Zhongwei), Sinopharm Group The new inactivated coronavirus vaccine developed by China Biotechnology Corporation and its affiliates was approved for clinical trials on the 13th. Beijing will make every effort to promote the application of the vaccine as soon as possible.
Yesterday, Kexing Holdings Biotechnology Co., Ltd. announced that the Phase I clinical study of its new coronavirus inactivated vaccine, Claire Fu TM, developed by Kexing Zhongwei was officially launched in Suining County, Xuzhou City, Jiangsu Province. Successfully entered the group and completed the first vaccination. It is reported that a total of 144 healthy volunteers aged 18 to 59 were recruited in the first phase.
What are the characteristics of inactivated vaccines? What is the difficulty of research and development? In this connection, the reporter talked to the relevant person in charge of Beijing Kexing Zhongwei Biotechnology Co., Ltd. The company is located in Shangdi Industrial Base, Haidian District, and has decades of experience in vaccine development.
Clinical study of inactivated vaccine has started
Beijing News: What is an inactivated vaccine? What is the principle?
Mr. Liu: Inactivated vaccine refers to a vaccine prepared by physical or chemical treatment that makes the virus lose its infectivity and replication, but retains the activity of the virus that can cause the human immune response.
We conducted a structural interpretation and analysis of the coronavirus, killing the nucleic acid of the virus, effectively retaining all the appearance of the virus. The protein structure of the inactivated virus and the real virus are the same, but there is no infectivity. Such a virus does Once the finished vaccine enters the human body, it can arouse the immune system to produce antibodies.
Beijing News: How many steps are there for inactivated vaccine development? What is the current stage?
Mr. Liu: In the preliminary research and development process, we must first obtain the virus, carry out the cultivation and isolation of the virus, and at the same time analyze and interpret the structure of the virus, and then make the vaccine through the inactivation process. In this process, a series of process exploration and quality standards are established.
After the vaccine is developed, it is necessary to conduct animal experiments first, generally starting from mice, and then transitioning to guinea pigs and monkeys in sequence. After vaccination, a series of tests are performed to obtain the vaccine safety and effectiveness evaluation results; After the control and quality are stable, apply to the State Drug Administration for clinical trials.
At present, the new crown inactivated vaccine for clinical trials has passed the inspection of the Chinese People's Procuratorate, and the clinical study started on April 16.
Beijing News: What difficulties were encountered during the research and development process? How to make a breakthrough in the end?
Mr. Liu: Isolation, cultivation, inactivation of new coronavirus and animal challenge protection experiments need to be carried out under the conditions of P3 laboratory (biological safety protection level three laboratory), but none of the vaccine companies have production workshops or laboratories with P3 conditions . To this end, we have cooperated with five P3 laboratories in Zhejiang and Beijing where the national scientific research institute is located to carry out relevant research.
The global epidemic is serious and time is urgent. This is the biggest difficulty. The researchers and the expert team of the collaborating unit cooperated with each other. They completed the preclinical research of the vaccine with high quality in a short period of time.
Follow-up studies on marketed vaccines will ensure safety
Beijing News: How long does it usually take for vaccine research and development? How did the vaccine development speed up?
Mr. Liu: Normally, it takes at least 8 years or even more than 20 years of long research and development process from the development of a new vaccine to the official launch. With the rigorous and efficient review by the State Food and Drug Administration and the full support of the scientists from the cooperating units, the development of new inactivated coronavirus vaccines has been rapidly advanced without reducing the standards and procedures.
Taking the review and approval of the State Food and Drug Administration as an example, Kexing Zhongwei has submitted 18 rounds of application materials to the Drug Evaluation Center (CDE) of the State Food and Drug Administration since March 13th. Sampling was organized for a while, and the Chinese Procuratorate quickly carried out simultaneous inspections. The pharmacy, pharmacology and toxicology, clinical reviewers and project managers of CDE worked overtime to conduct review and coordination, and implemented the requirements of "research and review linkage, simultaneous review". , Promoted the progress of the project.
Beijing News: How to ensure the safety of vaccines?
Mr. Liu: First of all, from the technical point of view, in the preparation process of inactivated vaccines, the virus will be inactivated, and only the appearance of the virus will be retained, so that the virus is not infectious. Secondly, after the vaccine is developed, the general general procedures need to go through rigorous animal experiments and phase I, II, and III clinical trials before they can apply for marketing. Finally, after going public, companies will continue to conduct follow-up studies on vaccines already on the market to understand the long-term safety and effectiveness of vaccines.
Complete the construction of vaccine production workshop within the year
Beijing News: How will the clinical trial of the new crown vaccine proceed?
Mr. Liu: At present, the new crown inactivated vaccine for clinical trials has passed the inspection of the Chinese People's Procuratorate and clinical research has been initiated. Kexing Zhongwei will implement clinical trials in strict compliance with GCP and relevant regulations in accordance with the requirements of the State Food and Drug Administration.
The Phase I and Phase II clinical trials of the vaccine are mainly to verify the safety and effectiveness of the vaccine. The next step will be to further expand the clinical application research.
Traditionally, Phase III clinical trials will be conducted, and the protective effect of the vaccine will be judged by the difference between the vaccine group and the control group of a larger sample of volunteers. The current epidemic situation in China has been controlled, and the global epidemic situation is constantly expanding. We are working with relevant departments Actively contact and discuss and closely track the development of the global epidemic situation to determine the next clinical plan.
But the direction is very clear, which is to quickly advance to the application of vaccines based on the completion of phase Ⅰ and Ⅱ clinical trials. At present, Kexing Zhongwei has started the construction of the vaccine production workshop at the same time, and it is expected to be completed within the year and meet the production conditions.
Beijing News: When is the vaccine expected to be put into use and to whom are it suitable?
Mr. Liu: The basis for the vaccine to be put into use is safe and effective. We will speed up the clinical research of the vaccines in phase I and phase II, hoping to obtain safe and effective results as soon as possible.
The application of vaccines must be compared with the risk of epidemic prevention and control and the risk and cost of vaccine application. We will continue to provide safety and effectiveness data of vaccine research to the government for reference and judgment. The government and the public are also concerned about the risk of outbreaks. Judgment will be made at this time to confirm when the vaccine will be used. There is currently no clear timetable.
The vaccine applicable population is subject to clinical research results and approval by the State Food and Drug Administration based on clinical research results. The volunteers recruited in the first phase of our Phase I clinical study are adults aged 18-59 years old, and will be extended to the elderly and lower age groups one after another to protect more people.
Beijing News reporter Zhang Lu