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    Home > Active Ingredient News > Infection > Taiwan's high-end vaccine announced the data of the second phase test, the seroconversion rate of 28 days after the second dose reached 99.8%?

    Taiwan's high-end vaccine announced the data of the second phase test, the seroconversion rate of 28 days after the second dose reached 99.8%?

    • Last Update: 2021-06-16
    • Source: Internet
    • Author: User
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    On June 10, according to Taiwanese media reports, a meeting of IDMC's Independent Data Monitoring Committee, composed of independent scientific experts in Taiwan, was held at 1 p.
    m.
    that day.
    It was announced that the high-end vaccine (Medigen Vaccine Biologics) from Taiwan’s biopharmaceutical company Corp) developed the
    new coronary pneumonia vaccine phase II clinical trial analysis data showed that: safety and tolerability are good, all subjects did not have vaccine-related serious adverse reactions; in the immunogenic part, the vaccine does not distinguish between age groups.
    The seroconversion rate of the group 28 days after the second dose was 99.
    8%; the geometric mean titer (GMT titer) of the neutralizing antibody was 662, and the GMT magnification ratio was increased by 163 times

    .
    In the vaccine group between 20 and 64 years old, the seroconversion rate was 99.
    9%, the geometric mean titer of neutralizing antibody (GMT titer) was 733, and the GMT magnification ratio was 180 times higher

    .

    The new crown pneumonia immunization vaccine group after-administration of the second agent seroconversion rates (seroconversion rate) 28 days was 99.
    8%; the geometric antibodies mean titers (GMT titer) of 662, GMT magnification ratio is 163-fold increase

    .
    In the vaccine group between 20 and 64 years old, the seroconversion rate was 99.
    9%, the geometric mean titer of neutralizing antibody (GMT titer) was 733, and the GMT magnification ratio was 180 times higher

    .
    The seroconversion rate of the vaccine group at 28 days after the second dose was 99.
    8%; the geometric mean titer (GMT titer) of the neutralizing antibody was 662, and the GMT magnification ratio was 163 times higher

    .
    In the vaccine group between 20 and 64 years old, the seroconversion rate was 99.
    9%, the neutralizing antibody geometric mean titer (GMT titer) was 733, and the GMT magnification ratio was 180 times higher

    .

    The high-end new coronary pneumonia vaccine is developed using a subunit recombinant protein platform, using S-2P antigen with aluminum salt and CpG1018 adjuvant to make a finished vaccine
    .
    This S-2P antigen platform was transferred from the National Institutes of Health, with technical support provided by the American biological company Vaxess
    .
    The company Vaxess as Harvard and MIT-derived established, major shareholders include Massachusetts Institute of Technology Ventures The Engine, an internationally renowned biomedical venture capital Norwich Ventures, Bioinnovation Capital and so on

    .
    And a number of vaccine delivery vector development projects are funded by the Bill Gates Foundation, the National Science Foundation (NSF) and the National Institutes of Health (NIH)

    .

    S-2P antigen is combined with aluminum salt and CpG1018 adjuvant to make a finished vaccine
    .
    S-2P antigen is combined with aluminum salt and CpG1018 adjuvant to make a finished vaccine
    .

    S means the site of the new crown virus spike protein; 2P refers to the genetic modification of the two prolines of the spike protein, so that the S-2P vaccine antigen can be in the "prefusion" and "trimeric" configuration.
    The trimer" appears stably

    .
    In the adjuvant part, adjuvants can help antigen adsorption to maintain vaccine stability, enhance immune response, and induce immune bias

    .
    The high-end new coronary pneumonia vaccine uses aluminum salt and Dynavax CpG1018 as a collocation.
    This adjuvant combination has been verified to have a good Th1 immune bias, and has been
    approved by the US
    FDA , and has many years of experience in use, so that the vaccine development process has more safety evaluation data.
    , To accelerate the development of new coronary pneumonia vaccines

    .

    FDA

    According to the guidelines announced by the FDA on Friday, the neutralizing antibody efficacy level of the new crown vaccine must be equal to or higher than the efficacy level of the AstraZeneca COVID-19 vaccine before it can be considered for EUA
    .
    According to the results​​, High-end Vaccine said it will soon submit an EUA application to the FDA, increasing the possibility that the company's vaccine will become the first Taiwanese COVID-19 vaccine to enter the market

    .
    It will also apply to the European Medicines Agency and other international health authorities to start phase III clinical trials as soon as possible

    .

    However, since Taiwan’s candidate vaccines have not yet started a larger phase III trial, this is usually the criterion for determining efficacy-the FDA will allow the analysis of phase II results through immune bridging, which uses the immune response measured by clinical trial participants to infer The overall level of protection of the vaccine
    .

    According to the FDA, the analysis must be based on serum neutralizing antibody samples taken 28 days after more than 3,000 participants in a phase II clinical trial received the second dose of the vaccine
    .
    For an approved vaccine, the sample must have a neutralizing antibody geometric mean titer ratio (referring to antibody concentration) of at least 0.
    67 and a serum response rate (referring to reaction potency) of at least 50%, the FDA said

    .

    To obtain the EUA, the trial data of the high-end vaccine must be compared with the neutralizing antibody efficacy levels found in a control group of 200 AstraZeneca vaccinators at Taoyuan Hospital, and a decision will be made as early as July
    .

    Taiwan has signed a contract to purchase 5 million doses of high-end vaccines and another 5 million doses from United Biomedical Inc.
    The contract is reported that the company is about to complete its own phase II trial

    .
    Critics, including a scientist who recently resigned from the government’s vaccine review committee in protest, believe that Tsai Ing-wen’s statement on this issue has put undue political pressure on regulators to approve the vaccine

    .

    Taiwan began to launch its first dose of COVID-19 vaccine purchased on March 22.
    As of Thursday morning, it had received 759,746 doses of AstraZeneca vaccine

    .
    Taiwan has also signed a contract to purchase nearly 20 million doses of vaccines from abroad through the COVAX program, including 5.
    05 million doses of Moderna, 10 million doses of AstraZeneca, and 4.
    76 million doses of unspecified brand vaccines

    .

    Reference material: https://focustaiwan.
    tw/society/202106100015

    https://focustaiwan.
    tw/society/202106100015

     



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