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    Home > Active Ingredient News > Infection > The FDA released an analysis of the new crown vaccine developed by Des America and the United States: compliance with emergency use authorization standards

    The FDA released an analysis of the new crown vaccine developed by Des America and the United States: compliance with emergency use authorization standards

    • Last Update: 2020-12-14
    • Source: Internet
    • Author: User
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    The U.S. Food and Drug Administration (FDA) released an analysis on the 8th, clinical results show that the German bio-new technology company and Pfizer Pharmaceutical Co. , Ltd. of the United States developed a new crown vaccine in line with the FDA's emergency use authorization standards.
    The 53-page FDA report, released the same day, confirms a trial result disclosed by Pfizer in November that its co-developed new crown vaccine is 95 percent effective in preventing symptomatic new coronavirus infections, the Wall Street Journal reported.
    report that the new crown vaccine meets the criteria for authorization for emergency use.
    Phase 3 clinical trial of the vaccine, which began on July 27 this year, has so far recruited 44,000 subjects worldwide.
    the FDA's report analyzed health data on 19,000 of the subjects.
    report, there is evidence that the new crown vaccine is given in two doses, three weeks apart, and begins to protect the body after the first dose.
    reported that 70% of the subjects experienced side effects of one to two days after vaccination, including soreness, fatigue, headache, joint pain, fever and other symptoms at the injection site.
    the vaccine is effective for people of all ages, weights and races, according to the report.
    , however, the report showed that the majority of the subjects were white and most were under the age of 55.
    washington post that the report is preliminary information provided by the FDA before approving the new vaccine.
    FDA will hold a meeting of the Advisory Committee on Vaccines and Related Biological Products (VRBPAC) on the 10th to vote on whether the vaccine is effective in preventing new coronavirus infections in people 16 years of age and older.
    meeting, the FDA will decide whether to approve the emergency use authorization for the vaccine.
    Pharmaceuticals and Modner Biotech filed applications for emergency authorization for the new crown vaccine in the U.S. at the end of November, Reuters reported.
    both vaccines are mRNA (messenger RNA) vaccines.
    new crown vaccine developed by the latter will be reviewed by the FDA next week.
    it was also reported that UK regulators last week approved a new crown vaccine developed in partnership with German and American companies and began vaccinating on the 8th.
    the vaccine is currently under review in the European Union.
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