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The announcement follows the company’s recent approval of the company’s COVID-19 mRNA vaccine in Argentina, Canada, Israel, the United States and Taiwan for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children older than 6 months to 5 years. years
CAMBRIDGE, MA /ACCESSWIRE /July 18, 2022 /Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) treatments and vaccines, announced that the Australian Therapeutic Goods Administration (TGA) granted provisional registration for the use of Moderna’s COVID-19 mRNA vaccine, Spikevax, in a series of two 25 mcg doses consistent with the dose for active immunization to prevent COVID-19 caused by COVID-19 SARS-CoV-2 in children older than 6 months to five years. So far, young people under the age of six have been the only age organisation not eligible for COVID-19 vaccination in Australia.
“We are very pleased that our vaccine for children under the age of six has obtained provisional approval from the TGA,” said Michael Azrak, Moderna’s managing director for Australia and New Zealand. “The continued evolution of COVID-19 represents an emerging risk to global public health, adding young young people. Since the beginning of the pandemic, we have worked with a deep sense of duty to deliver on the promise of mRNA science for all Australians. The approval of the TGA gives all parents and carers in Australia the opportunity to their SARS-COV-2 youth. “
The positive intermediate effects of the KidCOVE Phase 2/3 study, announced on March 23, 2022, showed a physically powerful neutralizing antibody reaction in the age organization from 6 months to five years after a number one series of two doses of 1273-mRNA, as well as a favorable protection profile. Antibody titers in pre-specified age suborganizations of 6 months to 23 months and 2 to 5 years met the statistical criteria of similarity with adults in the COVE study, which met the study’s number one objective. Preliminary efficacy research in PCR-confirmed instances collected with the Omicron wave showed efficacy estimates similar to those of adults after two doses of 1273-mRNA compared to Omicron in the 6-month to 5-year age group.
The KidCOVE is conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), which is a component of the U. S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. USA The ClinicalTrials. gov ID is NCT04796896.
Moderna is committed to supporting the Australian government in implementing the COVID-19 program in young people aged 6 months to five years after receiving advice from the Australian Technical Advisory Group on Immunization (ATAGI).
The TGA has in the past approved the use of Moderna’s COVID-19 mRNA vaccine, Spikevax (elastomeric mRNA vaccine), for active immunization to protect you from COVID-19 caused by SARS-CoV-2 in others six years of age or older.
Permitted Use
The Therapeutic Goods Administration has provisionally approved the use of Moderna’s COVID-19 mRNA vaccine, Spikevax (elastomer mRNA vaccine), for active immunization to protect you from COVID-19 caused by SARS-CoV-2 in others 6 months of age and older.
About Moderna
In the 10 years since its inception, Moderna has grown from a clinical trials company advancing systems in the messenger RNA (mRNA) box to a company with a varied clinical portfolio of vaccines and therapies in seven modalities, a broad portfolio of high-level assets in spaces such as mRNA formulas and lipid nanoparticles, and a built-in production facility that enables immediate large-scale clinical and advertising production. Moderna maintains alliances with a wide variety of national and foreign government and business partners, which has and immediately scaled up production. More recently, Moderna’s features have been combined to enable the legal use and approval of one of the oldest and most effective vaccines in the face of the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in the basic and implemented science of mRNA, generation and delivery manufacturing, and has enabled the progression of treatments and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named one of Science’s top biopharmaceutical employers for the past seven years. For more information, visit www. modernatx. com.
Forward-Looking Statements
This message comprises forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which add with respect to: the progression of the Company’s COVID-19 vaccine (mRNA-1273, or Spikevax ); the approval of the vaccine in children older than 6 months to five years through the Administration of Therapeutic Goods; and the safety, efficacy, and tolerability of the vaccine in children aged 6 months to five years. The forward-looking statements contained in this press release are not promises or guarantees, and you deserve not to place undue reliance on such forward-looking statements because they involve known and unknown dangers, uncertainties and other matters, many of which are beyond the of Moderna and which may cause actual effects to differ materially from those expressed or implied by such forward-looking statements. These dangers, uncertainties and other items come with the other dangers and uncertainties described under “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC). and in upcoming presentations made through Moderna. with the SEC, which can be found on the SEC’s website at www. sec. gov. Except as required by law, Moderna disclaims any purpose or duty to update or revise any forward-looking statements contained in this article due to new information, long-term progressions or otherwise. These forward-looking statements are based on Moderna’s existing expectations and speak only as of the date hereof.
Modern Contacts
Media:Luke Mircea-WillatsDirector, Media Relations and comunicacionesLuke. mirceawillats@modernatx. com
Investors: Lavina TalukdarRomand vice president and head of inversiones617-209-5834Lavina. Talukdar@modernatx. com
SOURCE: Moderna, Inc.
Check out the edition in accesswire. com: https://www. accesswire. com/709014/Therapeutic-Goods-Administration-Grants-Provisional-Approval-for-Modernas-COVID-19-Vaccine-in-Children-Aged-Six- Month to five years