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    Home > Active Ingredient News > Drugs Articles > China's first new coronavirus recombination protein sub-unit vaccine start-up Phase III clinical

    China's first new coronavirus recombination protein sub-unit vaccine start-up Phase III clinical

    • Last Update: 2020-12-19
    • Source: Internet
    • Author: User
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    On December 3rd, the new coronavirus recombination protein sub-unit vaccine, developed jointly by the Institute of Microbiology of the Chinese Academy of Sciences and Zhifei Bio, has recently started phase III clinical trial preparations on the basis of the completion of Phase I/II clinical trials.
    Phase III clinical trial of the new coronavirus recombinant protein sub-unit vaccine will be conducted in people 18 years of age and older, using a randomized, double-blind, placebo-controlled international multicenter clinical trial, with a global plan to recruit 29,000 people.
    currently, the Institute of Microbiology of the Chinese Academy of Sciences and Zhifei Bio are actively promoting phase III clinical trials of the vaccine in Uzbekistan, Indonesia, Pakistan and Ecuador.
    the new crown vaccine was approved for clinical trials by the National Drug Administration on June 19.
    June 23, healthy adults over the age of 18 were recruited in Beijing, Chongqing and Hunan provinces, and randomized, double-blind, placebo-controlled Phase I and II clinical trials were conducted.
    October 22nd, critical data on safety and immunogenicity from Phase I and II clinical trials were revealed, and the vaccine showed good safety and immunogenicity in clinical trials.
    November 4, CDE held the vaccine Phase III clinical trial program communication and exchange consultation, Phase III clinical program was improved and confirmed, Anhui Zhifeilong Coma Company can be declared clinical program to carry out international multi-center Phase III clinical trials.
    It is understood that Anhui Zhifeilong Coma company in September obtained a drug production license change, increased the reorganization of the new coronary vaccine matters, the new crown vaccine workshop was also put into use in the same month, trial production is smooth, can produce more than 300 million doses per year.
    the vaccine uses a similar technical route to the hepatitis B vaccine, hepatitis E vaccine, cervical cancer vaccine, as a "recombined sub-unit vaccine", good safety.
    new coronavirus recombinant protein sub-unit vaccine developed by the research team of the Institute of Microbiology of the Chinese Academy of Sciences, with independent intellectual property rights, is China's science and technology anti-epidemic in the field of vaccine research and development in parallel promotion of one of the five technical routes.
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