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    Home > Active Ingredient News > Infection > The detailed data of the Phase III clinical trial of Kexing's new crown vaccine disclosed: the protective effect is 50.7%, and 100% prevents severe COVID-19

    The detailed data of the Phase III clinical trial of Kexing's new crown vaccine disclosed: the protective effect is 50.7%, and 100% prevents severe COVID-19

    • Last Update: 2021-04-24
    • Source: Internet
    • Author: User
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    On April 11, local time, the Butantan Institute published a study titled Effectiveness and Safety of a COVID-19 Inactivated Vaccine in Healthcare Professionals in Brazil: The PROFISCOV Study in the preprint database SSRN of The Lancet, revealing The final results of the Phase III clinical trial of CoronaVac, a new inactivated vaccine from China's Kexing Company, in the prevention of new coronavirus pneumonia (COVID-19) in Brazil.

    In an environment with a higher virus exposure rate, the protective effect of two doses of vaccine against all symptomatic COVID-19 is 50.
    7%, and if the interval between two doses of vaccine is extended, the protective effect can even be further increased to 62.
    3%.

    In terms of preventing moderate and severe illnesses, this vaccine showed 83.
    7% and 100% efficacy, respectively.

    https://ssrn.
    com/abstract=3822780 This is a randomized, double-blind, placebo-controlled Phase 3 clinical trial.

    From July 21 to December 16, 2020, 12,396 health care professionals from 16 centers in Brazil participated in the study and received at least one dose of CoronaVac vaccine (3 μg/ 0.
    5 mL) or placebo, 9,823 One participant received two doses of the vaccine or placebo, with an interval of 14 days.

    The primary endpoint of the study is the number of symptomatic COVID-19 cases verified by RT-PCR 14 days after the second vaccination.

    The secondary endpoint is the effect of preventing the severity of COVID-19, and the incidence of adverse events within 7 days after the occurrence of an immune response.

    The data showed that a total of 253 of the participants finally included in the analysis were later diagnosed with COVID-19.
    Among them, 85 of the 4,953 participants who received two doses of the vaccine were infected, and 168 of the 4,870 participants in the placebo group occurred.
    .

    In terms of effectiveness, CoronaVac's main curative effect on symptomatic COVID-19 is 50.
    7% (95% CI 36.
    0-62.
    0), and the protective effectiveness of preventing moderate and severe cases is 83.
    7% and 100%, respectively.

    And the 6 severe COVID-19 cases all occurred in the placebo group.

    In terms of adverse reactions, the incidence of the vaccine group was 77.
    1%, which was higher than the data of 66.
    4% in the placebo group, which was mainly manifested as pain at the administration site.

    The effect of preventing COVID-19 after 1 dose of vaccine/placebo is worth noting that in some subjects, neutralizing antibody testing showed the seroconversion rate and geometry of B.
    1.
    128, P.
    1 and P.
    2 variants The average titers are similar.

    In January of this year, the Sao Paulo state government announced that the effectiveness of the Coxing vaccine was 78%, of which the effectiveness of the prevention of moderate and severe cases was 100%.

    The disclosure of new data further improves the information on vaccine effectiveness.
    Overall, Kexing Vaccine's data on COVID-19 is very encouraging.

    End reference materials: [1]https://papers.
    ssrn.
    com/sol3/papers.
    cfm?abstract_id=3822780
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