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    Home > Medical News > Latest Medical News > Novavax and SII are authorized for emergency use of vaccines in Indonesia

    Novavax and SII are authorized for emergency use of vaccines in Indonesia

    • Last Update: 2021-12-09
    • Source: Internet
    • Author: User
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    Gaithersburg, Maryland, November 2, 2021/PRNewswire/ - Novavax, Inc.


    Stanley C.


    Because the vaccine storage temperature is 2 to 8 degrees Celsius, existing vaccine supply channels with more traditional cold chain capabilities can be used, which may increase the availability of hard-to-reach areas and the national vaccination rate


    Adar Poonawalla, Chief Executive Officer of the Serum Institute of India, said: “The availability of safe and efficient vaccine supply, coupled with its convenient distribution, should be a key driver in helping Indonesia control the current coronavirus outbreak


    Novavax and SII have applied for Novavax new coronary pneumonia vaccine authorization in India and the Philippines, and submitted an emergency use list (EUL) application to the World Health Organization (WHO)


    Indonesia is a member of the International Pharmaceutical Inspection Agreement (PIC/S), which is a good production of human or veterinary medicines among regulatory agencies in more than 50 countries including the United States, the United Kingdom, the European Union, Australia and Canada.


    For more information about COVOVAX, including product features, prescription information and important safety information, please visit the Indonesian National Agency for Medicines and Food Control (Badan POM)


    Authorized use of Novavax new crown pneumonia vaccine in Indonesia

    For Covovax/new coronavirus recombinant spike protein 5 mcg to induce immunity to the new coronavirus to prevent adults aged 18 and over from contracting new coronary pneumonia, Badan POM has issued an emergency use authorization (EUA)


    Important safety information

    People who are allergic to the active substance or any of the vaccine's excipients should not use COVOVAX


    Regarding the Phase 3 Trial of NVX-CoV2373

    NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: PREVENT-19 trials conducted in the United States and Mexico, which showed a protection rate of 100% for moderate to severe cases and an overall effectiveness of 90.


    Novavax New Coronary Pneumonia Vaccine NVX-CoV2373 is a protein-based vaccine candidate, modified according to the genetic sequence of the first strain of SARS-CoV-2 (the disease-causing virus of new coronary pneumonia)


    Novavax's new crown vaccine is packaged in a ten-dose vial as a ready-to-use liquid formulation


    About Matrix-M™ adjuvant 

    Novavax's patented Matrix-M™ adjuvant based on saponin can stimulate antigen-presenting cells to enter the injection site, enhance the antigen presentation of local lymph nodes, thereby enhancing the immune response, and has shown a strong and well-tolerated effect


    About Novavax

    Novavax, Inc.


    For more information, please visitor contact us via Twitter and LinkedIn


    About Indian Serum Institute Pte Ltd

    Based on the number of doses produced and sold worldwide (over 1.


    Forward-looking statements 

    Anything in this article involves the future, operation plan and prospects of Novavax, NVX-CoV2373 and its partners, the continuous development of other Novavax vaccine candidates, the scope of development, the timing of future regulatory submissions and their impact, subsequent regulatory approvals, and vaccine shipments The expected timing of and the statement of Novavax’s possible role in helping to control the new crown epidemic in Indonesia are forward-looking statements
    .
    Novavax hereby reminds that the foregoing 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 of meeting various safety, effectiveness and product characteristics requirements alone or with partners, including the challenges related to process validation and analytical verification required by applicable regulatory agencies; it is difficult to obtain scarce ones.
    Raw materials and supplies; resource constraints on Novavax’s ability to pursue planned regulatory pathways, including human capital and manufacturing capabilities; the challenge of meeting contractual requirements under agreements with multiple commercial, government, and other entities; and Novavax’s submission to the US Securities and Exchange Commission (SEC) “Risk Factors” and “Management’s Financial Status and Operating Results” in the “Annual Report” on Form 10-K submitted for the year ended December 31, 2020 and the subsequent Form 10-Q “Quarterly Report” The risks and uncertainties set out in the "Discussion and Analysis" section
    .
    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 (see websites:andto discuss the above and other risks and uncertainties
    .
    The forward-looking statements in this press release only apply to the circumstances as of the date of this article, and we have no obligation to update or revise any of these statements
    .
    Our business is subject to significant risks and uncertainties, including the aforementioned risks and uncertainties
    .
    Investors, potential investors and any other persons should carefully consider the relevant risks and uncertainties
    .

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