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    Home > Active Ingredient News > Drugs Articles > Pfizer/BioNTech Announces Phase 3 Clinical Data of mRNA Vaccine: Strengthen Needle to Show High Effectiveness!

    Pfizer/BioNTech Announces Phase 3 Clinical Data of mRNA Vaccine: Strengthen Needle to Show High Effectiveness!

    • Last Update: 2021-11-03
    • Source: Internet
    • Author: User
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    According to Baidu's "New Coronavirus Pneumonia Epidemic Real-time Big Data Report", as of 22:00 on October 21, 2021, there have been more than 242 million confirmed cases (24295 million) worldwide and more than 4.
    94 million deaths
    .

    Recently, Pfizer and BioNTech jointly announced the results of a phase 3 randomized controlled trial of COVID-19 mRNA vaccine Comirnaty (BNT162b2), which evaluated the 30μg booster dose of Comirnaty in more than 10,000 subjects 16 years and older Effectiveness and safety
    .


    In this trial, subjects who had previously received the Comirnaty 2-shot vaccination program were vaccinated with a booster dose of Comirnaty


    It is worth mentioning that this is the first batch of efficacy results of any randomized, controlled COVID-19 vaccine booster dose trial
    .


    The data shows that when the Delta variant is prevalent, compared with subjects who did not receive a booster dose, the protective effect of subjects vaccinated with a booster dose against COVID-19 returned to the higher level after the second injection Level, showing a relative vaccine efficacy of 95.


    In this trial, all subjects have previously completed the Comirnaty 2-injection immunization program, and then randomly receive a 30μg booster dose (the same dose intensity as the 2-injection series) or placebo at a 1:1 ratio
    .


    The median time between the second dose and the booster or placebo dose is about 11 months


    The median age of the study subjects was 53 years old, 55.
    5% of the subjects were between 16-55 years old, and 23.
    3% of the subjects were 65 years and older
    .


    Analysis of multiple subgroups shows that the effectiveness is consistent regardless of age, gender, race, race, or comorbidity


    Pfizer and BioNTech plan to submit detailed results of the trial for publication in peer-reviewed journals
    .


    The two parties also plan to share this data with the U.


    Pfizer/BioNTech’s COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology and is jointly developed by BioNTech and Pfizer
    .


    BioNTech is the holder of marketing authorizations in the United States, the European Union and the United Kingdom, as well as the holder of emergency use authorization (EUA) or equivalent authorizations in the United States (together with Pfizer), Canada, and other countries


    Comirnaty is a COVID-19 vaccine that has been approved by the US FDA as a 2-shot immunization program for immunization of people aged 16 and over to prevent COVID-19


    The vaccine has also been granted an emergency use authorization (EUA): (1) a 2-shot immunization program for immunization of adolescents aged 12-15 to prevent COVID-19; (2) for those who are 12 years of age and older with weakened immune function For the population, the third dose of immunization is provided


    At the same time, the vaccine was also granted EUA as a single-dose booster: (1) for people 65 years and older; (2) people aged 18-64 with high risk of severe COVID-19; (3) 18-64 years old People who are often exposed to SARS-CoV-2 in institutions or occupations; (3) For individuals who have completed primary immunization with a different COVID-19 vaccine


    Note: The original text has been deleted

    Original source: Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine

    Original source: Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine
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