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    Home > Active Ingredient News > Immunology News > China Biological Lancet publishes data on the use of Sinopharm's new crown vaccine among 3-17 year-olds

    China Biological Lancet publishes data on the use of Sinopharm's new crown vaccine among 3-17 year-olds

    • Last Update: 2021-10-01
    • Source: Internet
    • Author: User
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    The latest research results show that the Sinopharm China Bio-New Crown Inactivated Vaccine is safe and well tolerated at all dose levels for subjects aged 3-17 years
    .

    After inoculating two doses of inactivated COVID-19 vaccine, it can trigger a strong immune response against the COVID-19 virus
    .

    In order to further evaluate the safety and immunogenicity of the new coronavirus inactivated vaccine used in people aged 3-17 years, the Beijing Institute of Biological Products of Sinopharm Group launched an evaluation of the new coronavirus inactivated vaccine (Vero cell) in 3- Results of a randomized, double-blind, placebo-controlled phase I/II clinical trial on the safety and immunogenicity of vaccination in a 17-year-old healthy population
    .

    On September 15th, the international medical academic journal "The Lancet Infectious Diseases" (The Lancet Infectious Diseases) officially published a project entitled "Safety and immunogenicity of an inactivated COVID-19vaccine, BBIBP-CorV" by the Beijing Institute of Biological Products of China.
    , in people younger than 18years: a randomised, double-blind, controlled, phase 1/2 trial" research results
    .

    The study was carried out at the Center for Disease Control and Prevention in Liangyuan District, Shangqiu City, Henan Province, China.
    A randomized, double-blind, controlled phase I/II clinical trial was used, and vaccination was carried out according to the 0,28,56-day schedule
    .

    Healthy subjects were divided into groups of different ages and different doses for stratification and inclusion in the trial
    .

    Safety data show that the main local adverse reaction is pain at the injection site [3-5 years old group, 6-12 years old group, 13-17 years old group: 4%, 9.
    1%, 7.
    9%, respectively]
    .

    The systemic adverse reaction was fever [12.
    7%, 5.
    2%, 10.
    3% for 3-5 years old group, 6-12 years old group, and 13-17 years old group, respectively]
    .

    The severity of adverse reactions is mostly mild
    .

    Immunogenicity research data showed that after vaccination with the new coronavirus inactivated vaccine (Vero cells) according to the 0, 28, and 56 days immunization schedule, the results showed that the immunogenicity at 28 days after 3 doses was higher than 28 days after 2 doses.
    The anti-neovirus neutralizing antibody GMT of the target dose group for subjects 13-17 years old, 6-12 years old, and 3-5 years old at 28 days after immunization was 199.
    1, 184.
    8, and 199.
    1, respectively
    .

    Studies have shown that in the low-dose, medium-dose and high-dose groups 28 days after the full course of immunization, the 4-fold growth rate of neutralizing antibodies and IgG antibodies is 100%
    .

    The GMT levels of neutralizing antibodies and IgG antibodies of the low, medium, and high-dose test vaccines increased significantly at 28 days after the full vaccination; the GMT levels of neutralizing antibodies and IgG antibodies in the middle and high-dose groups were 28 days after the full vaccination The level is higher than that of the low-dose group
    .

    The research was led by researcher Yang Xiaoming, chief scientist of the "863 Program" of the Ministry of Science and Technology, Chairman of China Biotech, and Chief Physician Xia Shengli of Henan CDC.
    It was completed by the Centers for Disease Control and Prevention, China National Institutes for Food and Drug Control and many other institutions and units.
    Researchers Xiaoming Yang and Professor Guo Wanshen of China Biosciences are the co-corresponding authors of the article.
    Chief physician Xia Shengli, Dr.
    Zhang Yuntao, Chief physician Wang Yanxia and researcher Wang Hui are the joint authors.
    The first author
    .

    Link to the paper: https://doi.
    org/10.
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