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    Home > Active Ingredient News > Infection > The world's first bivalent new crown vaccine Phase 2/3 clinical results announced, the effectiveness is more than twice that of the current best vaccine, and it will be launched in autumn

    The world's first bivalent new crown vaccine Phase 2/3 clinical results announced, the effectiveness is more than twice that of the current best vaccine, and it will be launched in autumn

    • Last Update: 2022-05-17
    • Source: Internet
    • Author: User
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    How is the bivalent new crown vaccine different, and how effective and safe is it?

    How is the bivalent new crown vaccine different, and how effective and safe is it?

    Guided reading

    Guided reading

    mRNA-1273.


    On April 19, 2022, Moderna announced the phase 2/3 clinical study data of its bivalent vaccine mRNA-1273.


    The data shows that in the phase 2/3 clinical study of the vaccine, mRNA-1273.


    It is worth mentioning that in a recent large-scale real-world data set in Singapore, Moderna’s new crown vaccine mRNA-1273 performed the best, followed by Pfizer’s, and then China Biotech and Kexing’s new crown vaccine


    It is worth mentioning that Livzon Group, a Chinese pharmaceutical company, is also developing the Beta/Delta bivalent new crown vaccine


    01

    01

    Basic overview of the bivalent new crown vaccine mRNA-1273.


    Basic overview of the bivalent new crown vaccine mRNA-1273.


    Moderna's initial mRNA vaccine is named mRNA1273, and the so-called bivalent vaccine mRNA-1273.


    If you don't understand it, you can compare it to the multivalent HPV vaccine, and you can immediately understand what bivalent means


    Coming back to this paper, published in preprint, titled Safety, Immunogenicity and Antibody Persistence of a Bivalent Beta-Containing Booster Vaccine


    In this Phase 2/3 trial, Moderna evaluated the use of mRNA-1273.


    In this clinical study, 895 subjects, all over the age of 18, distributed in 9 clinical centers in the United States, have received standard two doses of mRNA1273 vaccine at least 6 months ago


    The booster subjects were all vaccinated with mRNA-1273.


    The following table provides details of the distribution of personnel participating in this clinical study


    02

    02

    How safe is the bivalent new crown vaccine mRNA-1273.


    How safe is the bivalent new crown vaccine mRNA-1273.


    The safety indicator of this clinical study is the number and percentage of any local and systemic adverse reactions that occurred within 7 days after vaccination, as shown in the figure below
    .

    In the above figure, Grade 1 in gray indicates mild adverse reactions, which are first-level reactions, blue for moderate adverse reactions (second-level), and red for third-level adverse reactions
    .

    In the above figure, Grade 1 in gray indicates mild adverse reactions, which are first-level reactions, blue for moderate adverse reactions (second-level), and red for third-level adverse reactions
    .

    Analyze the information above:

    The most common local adverse reaction within 7 days after injection of 50 μg dose of mRNA-1273.
    211 was injection site pain (85%; 253/298), and the most common systemic adverse reactions included fatigue (64%; 192/298), Headache (51%; 151/298) and myalgia (49%; 146/298)
    .

    The most common local adverse reaction with the 100 μg dose of mRNA-1273.
    211 was injection site pain (91%; 542/593), and the most common systemic adverse reactions were fatigue (70%; 413/593), headache (56%; 333 /593) and myalgia (56%; 335/593)
    .

    Among the participants who received 50 μg of the bivalent vaccine, the majority of adverse reactions were mild
    .
    Most of the participants who received 100 μg of the bivalent vaccine had mild or moderate adverse reactions
    .

    Overall, the reactogenicity profile of the 50 μg dose of mRNA-1273.
    211 was comparable to that of the mRNA-1273 primary series, while the 100 μg dose of mRNA-1273.
    211 had a higher incidence of local and systemic adverse reactions
    .

    03

    03

    Preliminary analysis of the efficacy data of bivalent vaccines

    Preliminary analysis of the efficacy data of bivalent vaccines

    In terms of immunogenicity (i.
    e.
    , efficacy), antibody levels using the bivalent vaccine as a booster were higher than those using the original vaccine at 28 and 180 days after booster vaccination, including against the original strain, Beta variant, and Delta variant and Omicron variants
    .

    Neutralizing antibody geometric mean titers after inoculation with 50 μg mRNA-1273.
    211 and 50 μg mRNA-1273 boosters

    Neutralizing antibody geometric mean titers after inoculation with 50 μg mRNA-1273.
    211 and 50 μg mRNA-1273 boosters

    Taking the Omicron variant as an example, the neutralizing antibody level of the 50 ug bivalent vaccine at 28 and 180 days after booster vaccination was 2.
    20 and 2.
    15 times that of the original vaccine, respectively
    .

    After preliminary analysis of the clinical data of the mRNA-1273.
    211 vaccine, we can look at the detailed data next
    .

    mRNA-1273 vaccine and mRNA-1273.
    211 bivalent vaccine, the production of neutralizing antibodies against the original strain and Beta strain (as shown in the following figure)
    .

    50-μg mRNA-1273/mRNA-1273.
    211 booster, neutralizing antibody production against the original strain, Beta, Omicron and Delta
    .
    (See below)

    Finally, we attach the antibody production against different strains, 50 μg and 100 μg mRNA-1273.
    211 vaccine, or 50 μg mRNA-1273 booster
    .
    (See below)

    04

    04

    last words

    last words

    The results of this paper show that the bivalent vaccine mRNA-1273.
    211 can induce an effective and durable antibody response as a booster, or can provide a better vaccination regimen for emerging mutants
    .

    According to Moderna, they are still evaluating the data obtained and are expected to start playing in some countries in the northern hemisphere this fall
    .
    The mRNA-1273.
    211 vaccine is primarily administered as a booster
    .

    Although the mRNA-1273.
    211 vaccine is not an exclusive vaccine for the Omicron strain, it still shows a good neutralizing response to Omicron
    .

    It is worth mentioning that Livzon Pharmaceuticals, a Chinese pharmaceutical company, is also currently working on the Beta/Delta bivalent vaccine, and it was previously rumored that it was developing a quadrivalent new crown vaccine
    .
    On April 2, Livzon Group denied this, saying that "the research and development of the fourth-stage vaccine for the new crown has not been carried out yet
    .
    "

    In the face of Omicron and new variants that may appear in the future, whether it is a new branch of Omicron or a brand new variant, how to develop a vaccine with stronger and longer-lasting protection is a very important part of the current vaccine development work in various countries
    .
    We also hope that domestic pharmaceutical companies will also step up vaccine research and development in this regard
    .

    refer to the original text

    refer to the original text

    1.
    Safety, Immunogenicity and Antibody Persistence of a Bivalent Beta-Containing Booster Vaccine.

    1.
    Safety, Immunogenicity and Antibody Persistence of a Bivalent Beta-Containing Booster Vaccine.

    https:// Johnny and Weibo

    2.
    Johnny and Weibo

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    weibo.
    cn/1728715190/4760125883023622

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    weibo.
    cn/1728715190/4760125883023622

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