China's new coronavirus inactivated vaccine is the first to obtain approval for clinical research——
Vaccine development and time race
Our reporter Ji Leilei
Vaccines are essential for the prevention and control of new coronary pneumonia.
On April 12, a new type of new coronavirus inactivated vaccine declared by Sinopharm Group Wuhan Biological Products Research Institute (hereinafter referred to as "Sinopharm Group China Biotechnology") was approved by the State Drug Administration for clinical trials. This is the world's first inactivated new coronavirus vaccine that has received clinical trial approval.
In the global vaccine research and development process, China has achieved a "leading position" in inactivated vaccine technology.
Vaccine development enters "wartime rhythm"
Since the outbreak of New Coronary Pneumonia, the CPC Central Committee and the State Council have attached great importance to the research and development of vaccines, and vaccine research and development has also entered a "wartime rhythm."
It is understood that Sinopharm China Biotechnology established a scientific research leadership team led by Yang Xiaoming, the chief scientist of the vaccine project of the "863" program of the Ministry of Science and Technology, on January 19, striving to tackle the three dimensions of diagnosis, treatment and research and development. At the same time, 1 billion yuan of research and development funds were arranged to deploy "two institutes and one hospital" (Wuhan Institute of Biological Products, Beijing Institute of Biological Products, China Institute of Biology) to develop new coronavirus vaccines on two technical routes.
On February 1st, with the efficient organization and strong promotion of the Biological Center of the Ministry of Science and Technology, China Bio as the lead unit won the key special project "2019-nCoV inactivation of the National Public Security Risk Prevention and Control and Emergency Technical Equipment" of the Ministry of Science and Technology The "Vaccine" project was urgently established.
In order to make the vaccine research and development successful as soon as possible, while carrying out scientific research on inactivated vaccines, emergency examination and approval work has also started simultaneously. The State Food and Drug Administration has opened a green channel for vaccine research and development institutions. They break the routine and submit relevant information in a rolling manner. The Wuhan Institute of Biological Products has successively submitted 13 rounds of electronic materials and 10 rounds of email response materials to the Drug Evaluation Center. The State Food and Drug Administration has conducted simultaneous audits and held multiple professional review meetings, which has greatly improved communication efficiency and review. speed.
On April 10, Wuhan Institute of Biological Products formally submitted the final version of the complete set of paper application materials to the Drug Approval Center and obtained the acceptance number.
On April 12, under the cooperation of multiple departments, the State Food and Drug Administration issued clinical trial approvals to the Wuhan Institute of Biological Products.
Repeated trials to ensure vaccine safety
The virus species is the basis for the development and preparation of vaccines.
According to Wang Zejun, director of the Research Institute of Viral Vaccines of Wuhan Institute of Biological Products, Wuhan Institute of Biological Products mainly carried out two aspects of work in January. The first is the research on the adaptation and passage of virus on cells; the second is that because the inactivated vaccine is to be developed, the inactivation process and inactivation conditions of the virus need to be determined to ensure the success of the inactivation of the vaccine.
The Wuhan Institute of Biological Products and the Wuhan Institute of Virology, Chinese Academy of Sciences, successfully isolated the virus strains in January, and jointly carried out the establishment of a virus seed bank. After rigorous screening and purification, a third-level virus seed bank was successfully established on February 28 .
On February 14, the scientific research team obtained purified antigen. Since February 16th, the immunogenicity of the vaccine has been carried out on various experimental animals such as rats, mice, guinea pigs, rhesus monkeys, and cynomolgus monkeys to verify the effectiveness of the vaccine.
On February 25, the scientific research team completed the establishment of the process and the determination of quality standards. On the animal model established by the Wuhan Institute of Virology, the Chinese Academy of Sciences, animal protection research was started. The vaccine proved to be very good in animals such as rhesus monkeys. Protection effect. According to Duan Kai, general manager of the Wuhan Institute of Biological Products, the research team of the Wuhan Virus Research Institute has fought continuously for many days at the last moment before rushing to complete the experiment on April 6.
In the vaccine development process, another important part is the preclinical safety evaluation, that is, the vaccine must first be proved to be safe in animals. Since March 8, the scientific research team has carried out safety evaluation work. At 5 a.m. on April 10, the repeated dose toxicity test report was completed.
Success stories continued. On March 18, the production of three batches of vaccines was completed. "These three batches of vaccines are important because China requires that three batches of qualified samples must be produced continuously before applying for clinical trials." Wang Zejun said. On April 4th, the inactivated vaccine produced by Wuhan Institute of Biological Products passed the self-test; on April 9th, it successfully obtained the verification report of the China Food and Drug Administration.
Vaccine is safe and effective in the future
The relevant person in charge of Sinopharm Group stated that the inactivated vaccine approved for clinical trials this time is a vaccine that kills the virus by physical or chemical methods, but still retains the activity of the virus to cause human immune response. This vaccine has a solid research foundation, features mature production technology, controllable quality standards, and a wide range of protection. It is widely used in the prevention of infectious diseases such as hepatitis A, influenza, hand-foot-mouth disease, and polio.
According to relevant laws and regulations, China Bio has fully prepared for emergency use. Wu Yonglin, President of China Bio said that China Bio reported that the clinical trial batch output of the new coronavirus vaccine exceeded 50,000 doses. After mass production, each batch produced more than 3 million doses, with an annual production capacity of more than 100 million doses. It is fully capable of producing large-scale inactivated vaccines. .
At present, Phase I and Phase II clinical trials of the new inactivated coronavirus vaccine have been carried out simultaneously in Wuzhi County, Jiaozuo, Henan. Under the careful organization of Henan Provincial Center for Disease Control and Prevention, Jiaozuo City Center for Disease Control and Prevention, and Wuzhi County Center for Disease Control and Prevention, the clinical trial was initiated immediately after obtaining clinical approval, and the first phase of 32 volunteers has been completed.
Zhu Jingjin, Secretary of the Chinese Biological Party Committee, said that since the outbreak of the New Coronary Pneumonia, scientific research personnel of Chinese biological organizations have carried out multi-dimensional and multi-level scientific research work, and have pioneered the development of nucleic acid molecular detection kits, and the first to propose plasma technical standards and treatment plans for convalescents , Becoming the first company in the world to obtain the clinical approval of the new crown inactivated vaccine.
At present, employees of the Chinese biological research front are still in a "wartime state", and there are still several scientific research projects that are rushing to work day and night. Looking forward to the near future, there will continue to be new news.
Ji Leilei