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    Home > Active Ingredient News > Infection > NEJM: Novavax recombinant protein vaccine has a protective power of 89.7%, which is effective against the mutant new coronavirus!

    NEJM: Novavax recombinant protein vaccine has a protective power of 89.7%, which is effective against the mutant new coronavirus!

    • Last Update: 2021-07-29
    • Source: Internet
    • Author: User
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    At the end of 2020, reports from the United Kingdom, Brazil and South Africa confirmed that the new coronavirus variants B.
    1.
    1.
    7, P.
    1 and B.
    1.
    351 are related to increased transmission, severe disease, and evasion of vaccines

    .
    The B.
    1.
    1.
    7 variant was discovered in the genome sequencing of a sample obtained from a COVID-19 patient in southeast England in early October 2020

    .
    The prevalence of B.
    1.
    1.
    7 variants has rapidly increased over time in Europe and the United States

    .

    NVX-CoV2373 vaccine (Novavax) is composed of 5μg recombinant nanoparticle spike protein and 50μg Matrix-M adjuvant.
    Early clinical research data shows that the two-dose regimen given 21 days apart is safe and can build a strong health population.
    Immune response

    .
    On June 30, the New England Journal published a Phase III, randomized, observer-blinded, placebo-controlled trial to evaluate the efficacy of NVX-CoV2373 in preventing Covid-19 among participants aged 18 to 84 in the UK.
    Immunity and safety

    .

    Paul T.
    Heath et al.
    Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.
    NEJM.
    DOI: 10.
    1056/NEJMoa2107659

    Paul T.
    Heath et al.
    Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.
    NEJM.
    DOI: 10.
    1056/NEJMoa2107659

    Of the 16,645 participants who were screened, a total of 15,139 participants received at least one dose of NVX-CoV2373 (7569 participants) or placebo (7570 participants); 14039 participants (7020 vaccine group) 7019 people in the placebo group) met the criteria for the efficacy population according to the plan, of which 48.
    4% were women; 94.
    5% were white, 2.
    9% were Asian, 0.
    4% were black, and 44.
    6% of participants had at least one serious new crown complicated Diseases, including chronic respiratory system, heart, kidney, nervous system, liver and immune system diseases, and obesity

    .
    2310 participants were included in the subgroup of adverse events

    .

     

    After the first and second doses, the vaccine group reported local adverse events more frequently than the placebo group

    After the first and second doses, the vaccine group reported local adverse events more frequently than the placebo group

    Among vaccinators, the most frequently reported adverse events were the first dose (53.
    3% had tenderness, 29.
    3% had pain), the second dose had tenderness or pain at the injection site (76.
    4% and 51.
    2%), and most of the severity was Grade 1 (mild) or Grade 2 (moderate), with a short average duration (2.
    3 days after the first dose of tenderness, and 1.
    7 days after the second dose)

    .
    Young vaccinators (18-64 years old) have more frequent local adverse events than older vaccinators (≥65 years old)

    .

    The most commonly reported systemic adverse events were headache, muscle pain and fatigue.
    Most of the events were grade 1 or grade 2 in severity and had a short average duration (1.
    6, 1.
    6, and 1.
    8 days after the first dose, respectively, and the second dose After 2.
    0, 1.
    8 and 1.
    9 days respectively)

    .
    A total of 3 vaccine recipients reported grade 4 adverse events.
    Two of them reported grade 4 fever (>40 °C), one after the first dose, the other after the second dose, and the third He was found to have a positive result of the new coronavirus PCR test.
    Five days after the first dose, he had six grade 4 adverse events: nausea, headache, fatigue, myalgia, fatigue and arthralgia

    .

    The most commonly reported systemic adverse events were headache, muscle pain and fatigue.
    Most of the events were grade 1 or grade 2 in severity and had a short average duration (1.
    6, 1.
    6, and 1.
    8 days after the first dose, respectively, and the second dose After 2.
    0, 1.
    8 and 1.
    9 days respectively)

    .
    The most commonly reported systemic adverse events were headache, muscle pain and fatigue.
    Most of the events were grade 1 or grade 2 in severity and had a short average duration (1.
    6, 1.
    6, and 1.
    8 days after the first dose, respectively, and the second dose After 2.
    0, 1.
    8 and 1.
    9 days respectively)

    .

    Younger vaccinators report systemic adverse events more often than older vaccinators, and the second dose has more adverse events than the first dose
    .
    2% of people had a fever after the first dose (body temperature ≥38°C), and 4.
    8% had a fever after the second dose

    .
    0.
    4% of people had grade 3 fever (39°C~40°C) after the first dose, and 0.
    6% had grade 4 fever (>40°C) after the second dose.
    There were 2 participants, 1 After the first dose, there was 1 person after the second dose

    .

    Another person who received the vaccine had a serious adverse event (myocarditis), which was 3 days after the second injection.
    Experts thought it might be viral myocarditis and recovered after 2 days of hospitalization

    .

    There are two deaths related to the new crown, one in the vaccine group and one in the placebo group
    .
    The death of the vaccine group occurred in a 53-year-old man who developed new coronary symptoms 7 days after the first injection; he was subsequently sent to the intensive care unit for treatment due to respiratory failure caused by the new coronary pneumonia, and finally died 15 days after the vaccination

    .
    The death in the placebo group occurred in a 61-year-old man who was hospitalized 24 days after the first dose; the participant died of complications from new coronary pneumonia and sepsis 4 weeks later

    .

    Among the 14,039 participants, 10 vaccinators and 96 placebo recipients had virologically confirmed, symptomatic mild, moderate, or severe Covid-19 cases, and they were in the second dose At least 7 days after the onset of disease, the vaccine protection is 89.
    7%

    .
    Among the participants over the age of 65, there were 10 patients with mild, moderate or severe COVID-19 (1 in the vaccine group and 9 in the placebo group)
    .
    Severe cases of COVID-19 occurred in five placebo participants, one patient was hospitalized, three went to the emergency department, and one participant was nursing home

    .
    All five patients had abnormal vital signs and needed supplemental oxygen with complications of new coronary disease

    .

    The protective power of the vaccine is 89.
    7%

    .
    The protective power of the vaccine is 89.
    7%

    .

    Among participants over 65 years of age, the overall vaccine protection was 88.
    9%; all participants had a protective effect of 83.
    4% 14 days after the first dose

    .

    Among participants over 65 years of age, the overall vaccine protection was 88.
    9%; all participants had a protective effect of 83.
    4% 14 days after the first dose

    .
    Among participants over 65 years of age, the overall vaccine protection was 88.
    9%; all participants had a protective effect of 83.
    4% 14 days after the first dose

    .

    Among the 10 vaccine cases, 8 cases were caused by the B.
    1.
    1.
    7 variant, 1 case was caused by the non-B.
    1.
    1.
    7 variant, and 1 case was unable to determine the virus strain

    .
    The protective efficacy of the vaccine against B.
    1.
    1.
    7 variants was 86.
    3%, and the protective efficacy against non-B.
    1.
    1.
    7 strains was 96.
    4%

    .
    There are too few non-whites to draw meaningful conclusions about changes in efficacy based on race or ethnic group
    .

    The protective efficacy of the vaccine against B.
    1.
    1.
    7 variants was 86.
    3%, and the protective efficacy against non-B.
    1.
    1.
    7 strains was 96.
    4%

    .
    The protective efficacy of the vaccine against B.
    1.
    1.
    7 variants was 86.
    3%, and the protective efficacy against non-B.
    1.
    1.
    7 strains was 96.
    4%

    .


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