Close Menu
    Facebook X (Twitter) Instagram
    BusinessNews.phBusinessNews.ph
    Subscribe
    • Top Stories
    • Business
    • Events / Conventions
    • National
    • Technology
    BusinessNews.phBusinessNews.ph
    Home » Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years
    Business

    Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years

    By Marie JonesJuly 19, 2022Updated:July 19, 2022
    Share
    Facebook Twitter LinkedIn Pinterest Email
    • Announcement follows recent authorization of the Company’s mRNA COVID-19 vaccine in Argentina, Canada, Israel, the US, and Taiwan for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to five years

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 25 ug per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years. Until now, children under six were the only age group not eligible for vaccination against COVID-19 in Australia.

    “We are pleased that our vaccine for children under six years of age has received provisional approval by the TGA,” said Michael Azrak, General Manager of Moderna for Australia and New Zealand. “The continued evolution of COVID-19 represents an emergent threat to global public health, including young children. Since the onset of the pandemic, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science to all Australians. The approval from TGA helps extend an opportunity to all parents and caregivers in Australia to protect their young children against SARS-COV-2.”

    Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.

    The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.

    Moderna is committed to supporting the Australian Government on the COVID-19 program implementation in children aged 6 months to five years upon receiving a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI).

    The TGA previously approved the use of Moderna’s mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six years or over.

    Authorized Use
    Therapeutic Goods Administration has provisionally approved the use of Moderna’s mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.

    About Moderna
    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

    Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

    Forward Looking Statements
    This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the development of the Company’s COVID-19 Vaccine (mRNA-1273, or Spikevax); the approval of the vaccine in children ages 6 months to 5 years by the Therapeutic Goods Administration; and the safety, efficacy, and tolerability of the vaccine in children ages 6 months to 5 years of age. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

    Moderna Contacts
    Media:
    Luke Mircea-Willats
    Director, Media Relations & Communications
    Luke.mirceawillats@modernatx.com

    Investors:
    Lavina Talukdar
    Senior Vice President & Head of Investor Relations
    617-209-5834
    Lavina.Talukdar@modernatx.com

    SOURCE: Moderna, Inc.

    For the latest business and finance news in Asia - Business News Asia
    Share. Facebook Twitter Pinterest LinkedIn Tumblr Email

    Related Posts

    Kingnet Acquired Type 4 and Type 9 Licenses: Continuously Broadening Business Boundaries and Advancing Global Expansion Layout

    July 15, 2025

    Graphene Aluminium Ion Battery Patent Granted and GMG and The University of Queensland Enter into New Collaboration Agreement

    July 14, 2025

    Buy International Homes at the Global Property Expo, Singapore

    July 14, 2025
    Latest News

    Kingnet Acquired Type 4 and Type 9 Licenses: Continuously Broadening Business Boundaries and Advancing Global Expansion Layout

    July 15, 2025

    Graphene Aluminium Ion Battery Patent Granted and GMG and The University of Queensland Enter into New Collaboration Agreement

    July 14, 2025

    Buy International Homes at the Global Property Expo, Singapore

    July 14, 2025

    Alpaca Network Announces Launch of Modelz: The First Decentralized Exchange for AI Models

    July 10, 2025

    Tianci international: Discussing Strategic Opportunities for the Shipping and Logistics Industry to Integrate with Blockchain technology and RWA

    July 10, 2025

    The 10th Quam IR Awards was Successfully Held

    July 10, 2025

    Cornerstone Robotics Launches First Clinical Evaluation of its Hong Kong-Developed Surgical Robotic System in UK

    July 10, 2025

    SAPPE’s Female CEO Takes the World Stage at the Global Summit of Women 2025 in Berlin, Germany

    July 10, 2025

    Tradable Bits Powers Fan Engagement for Rugby Australia’s Hosting of the Qatar Airways British & Irish Lions Men’s Tour 2025

    July 10, 2025

    Standard Chartered GBA Business Confidence Survey points to further tariff drag in H2

    July 9, 2025

    Valuufy partners with Mainichi Future Creation Lab, Supporting New Approaches to Business Sustainability

    July 9, 2025

    Malaysia and France Strengthen Defence Industry Ties with Landmark MoU Signing

    July 9, 2025

    GMG Commencing Sales of G(R) Lubricant and Advancing Regulatory Approvals

    July 9, 2025

    Small Businesses Embrace Social — But Could be Missing a Trick in the Age of AI

    July 7, 2025

    Kincora Secures Strategic North American Investors and Announces Private Placement

    July 7, 2025
    BusinessNews.ph
    • Home
    • Business News Asia
    • Cebu Lifestyle Channel
    • Property News
    • Events News Asia.com
    • Contact Us
    • Cebu Business News
    © 2025 All Rights Reserved | BusinessNews.ph

    Type above and press Enter to search. Press Esc to cancel.