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Kexing (SINOVAC) COVID-19 inactivated vaccine Approved in China
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Kexing (SINOVAC) COVID-19 inactivated vaccine Approved in China.
On February 6, the COVID-19 virus inactivated vaccine Kerlaifu developed by SINOVAC(Beijing Kexing Zhongwei), a subsidiary of Kexing Holding Biotechnology Co., Ltd., was conditionally approved in China. It only took 3 days from the submission of the listing application to the approval.
Kerlaifu is made by inoculating African green monkey kidney cells (Vero cells for short) with a new type of coronavirus (CZ02 strain).
It is made by culturing, harvesting the virus liquid, inactivating the virus, concentrating, purifying and adsorbing on aluminum hydroxide. It is suitable for vaccination of people aged 18 and above.
It is used to prevent diseases caused by new coronavirus infection. The basic immunization program is 2 doses, with an interval of 14-28 days, and each human dose is 0.5ml.
Up to now, China State Food and Drug Administration has approved the using of two COVID-19 vaccines. The first approved is the COVID-19 virus pneumonia inactivated vaccine (Vero cell) of SINOPHARM. It takes 7 days from submission of marketing application to approval.
It took one year from vaccine development to market launch
On January 28, 2020, Kexing Zhongwei launched a new coronavirus vaccine development project called “Crown Action”, and united with the Institute of Medical Laboratory Animals, Chinese Academy of Medical Sciences, China Center for Disease Control, Beijing Center for Disease Control and other units, According to the “wartime state”, the vaccine development work based on the technical route of inactivated vaccines will be promoted in parallel.
Kexing Zhongwei sent multiple groups of researchers to 5 P3 laboratories in Zhejiang and Beijing to carry out strain screening, process research, establishment and verification of verification methods, etc., and completed all pre-clinical vaccines in a short time with the expert team of the partner unit Research work includes the isolation and screening of the CZ strain for vaccine production from patients with confirmed COVID-19, the establishment of a three-level virus seed bank for vaccine production in accordance with GMP requirements; the determination of vaccine preparation processes and the establishment of key verification methods; single-dose vaccine toxicity Safety evaluations such as tests, allergenicity tests, repeated administration toxicity tests, etc.
On May 6, 2020, the results of the preclinical study of Kellyford published in the journal Science showed that Kellyford is safe and effective in the rhesus monkey model. This is also the result of the world’s first animal experimental study of a COVID-19 vaccine.
In June 2020, Kraft was the first to be approved for emergency use in China, and since July, it has been launching emergency use for specific groups of people in China. Beginning in September 2020, Kexing Zhongwei has submitted rolling registration materials to the Center for Drug Evaluation (CDE) of the National Medical Products Administration, and the State Drug Administration will carry out rolling reviews in accordance with the working mechanism of joint research and review and follow-up review. As of February 4, 2021, the company has submitted more than forty submissions in total.
After obtaining the vaccine protection efficacy results, Kexing Zhongwei formed a formal Phase III clinical research medical report and submitted it to CDE in accordance with the requirements of the State Food and Drug Administration, and submitted a conditional using application on February 3, 2021. The conditional approval for listing this time is based on the two-month results of the overseas phase III clinical protection efficacy test of Clareford. The final analysis data has not yet been obtained, and the effectiveness and safety results have yet to be further confirmed.
At the State Council’s joint prevention and control mechanism press conference on January 13 this year, Yin Weidong, Chairman, President and CEO of Kexing Holdings, once introduced that as of January 10, more than 7 million doses of Kerlaifu had begun to be supplied, especially Beijing, Guangdong and other places have been vaccinated on a large scale, and have seen good safety effects, and the effectiveness is being studied and tracked.
Since January 2021, countries such as Indonesia, Turkey, Brazil, Chile, Colombia, Uruguay, and Laos have successively approved the emergency use of Claret in the local area. Many countries have successively launched vaccines for high-risk groups such as medical staff and the elderly. Vaccination work. Relevant countries all recognize the results of Kexing Zhongwei’s existing clinical research and believe that the vaccine has a significant effect on reducing medical care, hospitalization, severe illness and death caused by COVID-19, and is of great significance for epidemic prevention and control.
Has good safety and immunogenicity
In the early stage, Kerlaifu has undergone rigorous animal experiments and phase I and II clinical studies. In China, it has completed phase I/II clinical studies for adults and elderly people over 18 years old. The clinical trials for children aged 3-17 years have completed all subjects. Group, the number of subjects exceeds 2,200. The results show that the vaccine has good safety and immunogenicity for people of all ages.
Starting from July 21, 2020, Cosing China will continue to carry out phase III clinical studies in Brazil and Chile in South America, Indonesia in Southeast Asia, and Turkey in the Middle East. These four countries are located in different regions and have their own characteristics. These studies used the same batch of vaccines, followed the same immunization procedures (0,14 procedures), and were independently carried out in accordance with the requirements of the drug clinical trial quality management regulations (GCP), with a total of 25,000 people enrolled.
Phase III clinical studies conducted in Brazil and Turkey respectively evaluated the protective efficacy of Kellyford in high-risk groups (medical staff receiving COVID-19 patients) and the general population. Both countries adopted multi-center, random, and A double-blind, placebo parallel control design, the primary endpoint is the incidence of new coronavirus-caused disease (COVID-19) 14 days after vaccination with 2 doses of vaccine or placebo.
As of December 16, 2020, a total of 12,396 subjects were enrolled in the Brazilian study of medical staff aged 18 and over, and 253 effective cases were obtained during the monitoring period. The protective effect of preventing the disease (COVID-19) caused by the COVID-19 virus (COVID-19) 14 days after vaccination according to the procedure of 0,14 days is: the protective effect for hospitalization, severe illness and death cases is 100%, for patients with obvious symptoms and need medical treatment The protective effect of the intervened COVID-19 cases is 83.7%, and the protective effect of all COVID-19 cases, including mild cases that do not require medical intervention, is 50.65%.
The target population of the Phase III clinical trial in Turkey is 18-59 year olds at high risk (K-1) and the general population at normal risk (K-2). As of December 23, 2020, the K-1 cohort was tested 918 subjects were enrolled in the K-2 cohort, 6453 subjects were enrolled in the K-2 cohort, and a total of 7371 subjects were enrolled. Among them, 1322 subjects completed two doses and entered the 14-day observation period after the second dose. Based on the analysis of 29 cases, the protective efficacy against COVID-19 after 14 days of vaccination with two doses of the vaccine on the 0,14 day program was 91.25%.
Kerlaifu production capacity will reach more than 1 billion doses
Kexing Zhongwei’s COVID-19 vaccine production quality management system has passed GMP inspections in China, Brazil, Indonesia, Chile and other countries. The large-scale production of hundreds of batches proves that the vaccine production process is controllable and the quality is reliable.
At the end of August 2020, Kexing Zhongwei’s first COVID-19 vaccine stock solution production line was put into trial use, with an annual production capacity of 500 million doses. The construction of the second dope production line has also been completed. It is expected that after it is put into use in February this year, it will increase the annual production capacity of Kerlaifu dope solution to more than 1 billion doses. Kexing Zhongwei is further accelerating the construction of vaccine raw liquid and finished product production capacity, and strives to match the filling and packaging capacity with the raw liquid production capacity.
On January 6, 2021, a reporter from the Beijing News visited Kexing Zhongwei’s COVID-19 inactivated vaccine production workshop and quality inspection laboratory in the Daxing Biomedical Industry Base. In order to ensure the supply of the COVID-19 vaccine, the staff here work in three shifts, 24 hours a day, and can produce hundreds of thousands of doses of the COVID-19 vaccine every day. With the completion of the second phase of the workshop, the daily output will exceed one million doses.
According to Liu Peicheng, Director of Brand and Public Relations of Kexing Holdings, a COVID-19 inactivated vaccine from the laboratory to the market needs to go through cell culture, virus culture, inactivation, purification, proportioning (semi-finished products), filling, and packaging. Steps, each step has more and more detailed links, and quality control testing runs through the whole process.
The COVID-19 inactivated vaccine produced by it has two packages, namely vials and pre-filled syringes, so filling and packaging are divided into two lines. Unlike the inactivated COVID-19 vaccine exported abroad, the COVID-19 inactivated vaccine for domestic use is individually packaged in individual doses, and there will be an exclusive traceability code on the packaging box, enabling full traceability. The COVID-19 inactivated vaccine sold abroad, because of its different policies and regulations from China, can contain multiple vaccines in the same packaging box.
Since the end of last year, Kexing Zhongwei has successively supplied vaccines to Brazil, Indonesia, Turkey, and Chile, which are cooperating in clinical research. Countries with vaccine filling and packaging capabilities such as Brazil, Indonesia and Turkey can also quickly obtain them by importing semi-finished products. vaccine. The supply of vaccines in the form of finished and semi-finished products not only alleviates the current mismatch in filling and packaging capabilities, saves international transportation costs, but also improves the availability and affordability of vaccines.
(source:internet, reference only)