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    Home > Medical News > Medical Research Articles > WHO approves Novavax vaccine to re-enter emergency use list

    WHO approves Novavax vaccine to re-enter emergency use list

    • Last Update: 2022-01-11
    • Source: Internet
    • Author: User
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    • Nuvaxovid? New crown vaccine ( of SARS-CoV-2 rS [ heavy group, adjuvanted ] ) the World Health Organization into emergency use list 
    • Nuvaxovid be admitted into the emergency use of the list ( the EUL ) , make up the so by the Serum Institute of India Covovax? In the name of raw production and sales of Novavax vaccine Emergency Use Authorization 
    • Shijie Weishengzuzhi emergency use list ( the EUL ) is to participate COVAX prerequisite exports of many countries and regions vaccine mechanism 

    Gaithersburg, Maryland, December 22, 2021/PRNewswire/ - Novavax, Inc.
    (NASDAQ: NVAX), a company dedicated to the next generation of severe infectious diseases The vaccine development and commercialization biotechnology company announced today that its recombinant protein nanoparticle vaccine NVX-CoV2373 containing Matrix-M adjuvant has been
    approved by the World Health Organization to be included in the Emergency Use List (EUL)
    .
    This vaccine is used to prevent new crown pneumonia caused by the new crown virus in individuals 18 years of age and older

    .
    Today’s emergency use list concerns the Nuvaxovid® new coronary pneumonia vaccine (SARS-CoV-2 rS [recombinant, adjuvanted]) that Novavax will sell in Europe and other markets

    .
    NVX-CoV2373 also by the private Serum Institute of India Ltd (SII) to Covovax? In the name of production and sales in India and the license area, this vaccine has been
    on December 17 eligible for emergency use columns list
    .
     Nuvaxovid and Covovax are based on the same Novavax recombinant protein technology, while EUL is based on common preclinical, clinical and chemical composition, manufacturing and quality control (CMC) data packages
    .

    Following the conditional marketing authorization from the European Commission , Nuvaxovid announced today that it has been listed as EUL, which also allows Nuvaxovid to pass the pre-qualification that meets the World Health Organization's quality, safety and effectiveness standards
    .
    EUL is a prerequisite for the export of vaccines to many countries and regions, including participating countries in the COVAX mechanism.
    The mechanism is established to distribute and distribute vaccines fairly

    .
    EUL also enables these countries and regions to expedite their own regulatory approvals to import and vaccinate the new crown vaccine

    .
    Novavax and SII have pledged to provide COVAX with a total of 1.
    1 billion doses of Novavax vaccine

    .

    Stanley C.
    Erck, President and CEO of Novavax, said: "Today's emergency use list highlights Novavax's continued need to significantly increase the availability of new crown vaccines worldwide by building protein-based options on a well-known platform.
    And potential

    .
    We thank the World Health Organization for the comprehensive assessment and look forward to helping solve the main obstacles to epidemic prevention and control, including practical obstacles to vaccine access and vaccine hesitation

    .
    "

    Dr.
    Seth Berkley, Chief Executive Officer of Vaccine Alliance Gavi, said: "We are very pleased that the Nuvaxovid vaccine has also been included in the WHO's emergency use list.
    This provides the world and COVAX participating countries with another promising vaccine and the fight against the new crown.
    Another means of pneumonia.

    Seth Berkley, CEO of Gavi, the Vaccine Alliance.
    With the safety and effectiveness of multiple variants, the strong potential to enhance the needle program, and the characteristics of being suitable for standard storage temperature, Nuvaxovid vaccine It will provide countries with new key options to protect the health of their populations

    .
    "

    Dr.
    Richard Hatchett, Chief Executive Officer of the Alliance for Epidemic Prevention and Innovation (CEPI), said: "The world's tool base for combating new coronary pneumonia has now added a new weapon from Novavax.
    This is very gratifying news.

    CEPI has accelerated the Novavax vaccine through investment.
    The clinical development and production of this vaccine has played a vital role in advancing this vaccine and achieving fair access to the vaccine through the COVAX mechanism

    .
    "

    EUL's approval is based on pre-clinical, manufacturing and clinical trial data submitted for review
    .
    This includes two pivotal Phase 3 clinical trials: PREVENT-19 trial recruited approximately 30,000 participants in the United States and Mexico, the results of which have been published in the
    New England Journal of Medicine ( NEJM ) ; the other is in The results of the trial for vaccine evaluation among 14,000 participants in the UK have also been announced in NEJM
    .
    In these two trials, NVX-CoV2373 showed high effectiveness and reliable safety and tolerability

    .
    As the vaccine is distributed, Novavax will continue to collect and analyze real-world data, including monitoring safety and variant evaluation

    .

    Novavax's new crown vaccine has recently obtained emergency use authorization (EUA) in Indonesia and the Philippines , and will be sold by SII in these two countries under the name Covovax
    .
    NVX-CoV2373 is currently being reviewed by multiple regulatory agencies around the world

    .
    The company expects to submit a complete CMC data package to the U.
    S.
    Food and Drug Administration (FDA) before the end of this year

    .
    The Nuvaxovid® brand name has not been authorized by the US FDA for use in the United States

    .

    For more information about Nuvaxovid and Covovax or to request more information, please visit the following websites: 

    Shijie WHO will Nuvaxovid? Included in the emergency use of the list of
    the World Health Organization (WHO) issued a Nuvaxovid? List of certified emergency use new crown vaccine (Recombinant, adjuvanted) for active immunization to prevent 18 years of age and older individual due to infection New crown pneumonia caused by the new crown virus
    .

    About NVX-CoV2373
    NVX-CoV2373 is a protein-based vaccine modified from the genetic sequence of the first strain of SARS-CoV-2 (the disease-causing virus of new coronary pneumonia)
    .
    The manufacture of NVX-CoV2373 uses Novavax recombinant nanoparticle technology to generate antigens derived from coronavirus spike protein, and uses Novavax’s patented saponin-based Matrix-M adjuvant to enhance immune response and stimulate the production of high levels of neutralization.
    And antibodies

    .
    NVX-CoV2373 contains purified protein antigen, which can neither replicate nor cause new coronary pneumonia

    .

    Novavax's new crown vaccine is packaged in a ten-dose vial as a ready-to-use liquid formulation
    .
    The vaccination protocol requires two intramuscular injections, 21 days apart, 0.
    5 ml each (5 micrograms of antigen and 50 micrograms of Matrix-M adjuvant)

    .
    The storage temperature of this vaccine is between 2-8 degrees Celsius, and the existing vaccine supply and cold chain channels can be used

    .

    Novavax has established a partnership in the production, commercialization and distribution of NVX-CoV2373 worldwide
    .

    About NVX-CoV2373 of 3 Qi trial
    NVX-CoV2373
    is Liang Xiang pivotal 3 Qi trial evaluated
    .
     

    In a randomized, placebo-controlled, observer-blinded study conducted in the United Kingdom with 14,039 subjects, its overall efficacy reached 89.
    7%

    .
    The primary endpoint is the first symptomatic (mild, moderate, or severe) new coronary pneumonia confirmed by polymerase chain reaction in adult participants who were seronegative at baseline (for new coronavirus) at least 7 days after the second injection

    .

    PREVENT-19 is a trial conducted in the United States and Mexico with more than 25,000 participants and an overall effectiveness of 90.
    4%

    .
    This is a 2:1 randomized, placebo-controlled, observational blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373

    .
    The primary endpoint of PREVENT-19 is that among adult participants who were seronegative at baseline (for the new coronavirus), symptoms (mild, moderate, or Severe) New coronary pneumonia

    .
    The statistical success criteria include a lower limit of 95% CI> 30%

    .
    The key secondary endpoint is the prevention of symptomatic moderate or severe new coronary pneumonia confirmed by PCR

    .
    The evaluation of these two endpoints was performed on volunteers who had not previously been infected with SARS-CoV-2 at least seven days after the second study vaccination

    .
    In both studies, the vaccine showed good overall tolerance and produced a strong antibody response

    .

    About Matrix-M? Adjuvant agents
    Novavax based saponins Patent Matrix-M? Adjuvant by stimulating antigen-presenting cells into the injection site, enhanced antigen presentation of the regional lymph nodes, enhance the immune response, proved to be effective and well tolerated
    .

    About Novavax
    Novavax, Inc.
    (NASDAQ: NVAXN) is a biotechnology company dedicated to the promotion of global health through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases

    .
    The company's proprietary recombination technology platform uses the power and speed of genetic engineering.
    The company's patented recombination technology platform uses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles to meet the urgent global health needs

    .
    The company's new crown vaccine NVX-CoV2373 has obtained emergency use authorization in Indonesia and the Philippines, and has submitted regulatory approvals in multiple markets around the world

    .
    NanoFlu? is the company's quadrivalent influenza nanoparticle vaccine, which has achieved all major goals in a pivotal Phase 3 clinical trial for the elderly

    .
    Novavax is currently conducting a Phase 1/2 clinical trial to evaluate a COVID-NanoFlu combination vaccine that combines the company's NVX-CoV2373 and NanoFlu vaccine candidates

    .
    These candidate vaccines all use Novavax's proprietary saponin matrix Matrix-M adjuvant to enhance the immune response and stimulate the production of high levels of neutralizing antibodies

    .

    For more information, please visit style="vertical-align: inherit;"> or contact us via Twitter , LinkedIn , Instagram and Facebook
    .

    Forward-looking statements The statements in
    this article concerning Novavax’s future, business plans and prospects, partnerships, the continuous development of NVX-CoV2373, the scope of future regulatory filings and actions, timing and results are all forward-looking statements, including Novax before the end of the year The plan to submit a complete CMC data package to the US FDA, the potential impact of Novavax and NVX-CoV2373 in addressing vaccine acquisition, pandemic control, and population protection
    .
    Novavax hereby reminds that the aforementioned forward-looking statements are subject to numerous risks and uncertainties, which may cause actual results to differ materially from those expressed or implied by such statements

    .
    These risks and uncertainties include: the challenges posed by meeting various safety, effectiveness and product characteristics requirements alone or with partners, including meeting requirements related to process certification and analytical verification specified by regulatory authorities; difficulty Access to rare raw materials and materials; resource constraints in terms of human capital and manufacturing capabilities affect Novavax's ability to seek regulatory approval paths in the planning; the challenges of meeting contract requirements based on agreements with multiple commercial, government, and other entities; and Novavax has submitted The section "Risk Factors" and "Management’s Discussion and Analysis of Financial Conditions and Operation Results" in the 10-K Annual Report to the U.
    S.
    Securities and Exchange Commission (SEC) as of December 31, 2020, and the subsequent Form 10-Q Other risk factors identified in the quarterly report

    .
    We remind investors not to rely too much on the forward-looking statements contained in this press release

    .
    We encourage you to read the documents we filed with the US Securities and Exchange Commission (available at
    style="vertical-align: inherit;"> and style="vertical-align: inherit;"> ) to discuss the above and other risks and uncertainties
    .
    The forward-looking statements in this press release only apply to the situation on the date of this article, and we have no obligation to update or revise any of the statements

    .
    Our business is affected by significant risks and uncertainties, including the aforementioned risks and uncertainties

    .
    Investors, potential investors and any other persons should carefully consider related risks and uncertainties

    .

    Contact: 

    Investment investor relations
    Novavax, Inc.

    Erika Schultz | 240-268-2022
    ir@novavax.
    com

    Solebury Trout
    Alexandra Roy | 617-221-9197
    aroy@soleburytrout.
    com

    Media Relations Ali Chartan | 240-720-7804 Laura Keenan Lindsey | 202-709-7521 media@novavax.
    com



     

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