The first in the world!
April 12
Novel coronavirus Inactivated Vaccine Obtained Clinical Trial Approval!
Related clinical trials have started!
There is no specific therapeutic drug in novel coronavirus, so the research and development of vaccine has attracted much attention and expectation. A few days ago, there was heavy news about vaccine research and development in Covid-19 — — Covid-19 Inactivated Vaccine Obtained Clinical Trial Approval! It is a big step forward for us to welcome the protection of vaccines.
On April 12th, a class of new drugs — —Inactivated novel coronavirus vaccine, obtained the clinical trial license of National Medical Products Administration. this isThe world’s first inactivated vaccine in Covid-19 with clinical trial approval.
It is understood that the vaccine is related.Clinical trials have started simultaneously.. According to the relevant national laws and regulations, it has been fully prepared for emergency use.
Previously, Sinopharm Group China Bio took the lead in developing a "searchlight" for diagnosing Covid-19 — —Nucleic acid molecular detection kit, the first to successfully launch the "ballast stone" for the treatment of critically ill patients — —Plasma technical standard and clinical treatment scheme of convalescent patients; Coupled with this research and development of Covid-19’s "killer" for the decisive battle against the epidemic — —Inactivated COVID-19 vaccineA series of major scientific research achievements have provided strong support for realizing the goal of "diagnosis, treatment and prevention" in COVID-19.
On February 1st, Sinopharm Group China Bio, as the lead unit, won the key project of "Public Safety Risk Prevention and Control and Emergency Technical Equipment" of the national key R&D plan of the Ministry of Science and Technology.2019-nCoV inactivated vaccineEmergency establishment of the project (project number is 2020YFC0842100).
Under the strong leadership of the CPC Central Committee and the State Council and the strong support of the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the Health and Health Commission, National Medical Products Administration and the State-owned Assets Supervision and Administration Commission of the State Council, Sinopharm Group China Bio has successively overcome a series of key technologies in the production and quality control of COVID-19 vaccine, such as vaccine strain screening, virus seed bank establishment, antibody preparation and identification, detection method establishment, production technology research, compatibility and formula screening, determined the technological route and product quality attributes, and quickly carried out and completed the evaluation of animal’s in-vivo effectiveness and safety, with successive achievements. The successful approval of the clinical trial will further lay the foundation for the "high-speed" start of inactivated vaccine in Covid-19.
inactivated vaccine
Inactivated vaccine refers to a vaccine that makes the virus lose infectivity and replication by physical or chemical treatment, but retains the activity of the virus that can cause human immune response.
Inactivated vaccine is the most effective vaccine research and development path for emerging infectious diseases.
Compared with other types of vaccines (such as genetically engineered recombination vaccines, adenovirus vector vaccine, attenuated influenza virus vector vaccine and nucleic acid vaccine),The inactivated vaccine has advanced research and development technology, mature production technology, controllable quality standards and good protection effect.Sinopharm Group China Bio has large-scale inactivated vaccine production capacity,The declared COVID-19 vaccine clinical trial batch output exceeds 50,000 doses. After mass production, each batch output exceeds 3 million doses, with an annual production capacity of more than 100 million doses.
Vaccine is very important for epidemic prevention and control. Since the outbreak, the scientific research team of the State Council Joint Prevention and Control Mechanism has set up a special class for vaccine research and development, according toInactivated vaccine, recombinant protein vaccine, adenovirus vector vaccine, live attenuated influenza virus vector vaccine and nucleic acid vaccine are five technical routes.A total of 12 R&D tasks have been laid out, and they are all progressing steadily at present.
Previously, the adenovirus vector vaccine of the Institute of Military Medicine of the Academy of Military Sciences has been approved to carry out clinical trials, and now it has entered the second phase of clinical trials.
The inactivated vaccine approved for clinical trials this time is a kind ofVaccines that kill pathogenic microorganisms but still maintain their immunogenicityIt has the advantages of mature production technology, controllable quality standards, wide protection range, etc., and can be used for large-scale vaccination, and there are internationally accepted standards to judge the safety and effectiveness of vaccines.
Inactivated vaccines in China have a good research foundation, and inactivated hepatitis A vaccine, inactivated influenza vaccine, inactivated hand-foot-mouth disease vaccine and inactivated polio vaccine have been widely used.
In this epidemic prevention and control war, the six biological products research institutes in Beijing, Wuhan, Chengdu, Lanzhou, Shanghai and Changchun and the China Biotechnology Research Institute of Sinopharm Group China Biological actively played the role of scientific research, focusing onCovid-19-related diagnostic reagents, plasma for patients recovering from illness, anti-novel coronavirus immunoglobulin, inactivated novel coronavirus vaccine, recombinant genetic engineering vaccine, monoclonal antibody, horse anti-Covid-19 serum.Waiting for scientific research.
Among them, Sinopharm Group China Bio-Shanghai Jienuo developed.Covid-19 nucleic acid molecular detection kit, the first batch has passed National Medical Products Administration certification and EU CE certification, and has supplied more than 1.3 million people to provinces, cities, Hong Kong, Macao and abroad.Plasma treatment technology for recovered patients, recommended by the joint prevention and control mechanism of the State Council, was included in the "Diagnosis and Treatment Plan" of National Health Commission. As of April 7, 2169 people have been collected plasma in China, and 648 cases have been treated clinically, with remarkable results. This therapy has been adopted and used in many countries. (Source: State-owned Xiaoxin WeChat)