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The announcement follows the 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 kids 6 months to five years

CAMBRIDGE, MA / ACCESS CABLE / July 18, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that the Australian Therapeutic Goods Administration (TGA) has granted provisional registration for use of the vaccine. of Moderna’s COVID-19 mRNA, Spikevax, in a two-dose series of 25 µg per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in kids from 6 months to 5 years. Until now, children under the age of six were the only age group that could not be vaccinated against COVID-19 in Australia.


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

Positive interim results from Phase 2/3 KidCOVE study, Announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5-year age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. Antibody titers in the prespecified age subgroups of 6 months to 23 months and 2 years to 5 years met the statistical criteria for similarity to adults in the COVE study, satisfying the primary objective of the study. Preliminary efficacy analysis in PCR-confirmed cases collected during the Omicron surge showed similar efficacy estimates against Omicron in the 6-month to 5-year age group as 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 from the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.

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


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The TGA formerly passed the use of Moderna’s COVID-19 mRNA vaccine, Spikevax (Elastomeric mRNA Vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in persons aged six years and older.

authorized use

The Therapeutic Goods Administration provisionally approved the use of Moderna’s mRNA COVID-19 vaccine, Spikevax (Elastomeric mRNA Vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people from 6 months of age.

About Modern

In the 10 years since its inception, Moderna has grown from a research-stage company advancing programs in the field of messenger RNA (mRNA) to a company with a diverse clinical portfolio of vaccines and treatments across seven modalities, a broad portfolio of intellectual property in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables rapid clinical and commercial-scale production. Moderna maintains alliances with a wide range of domestic and foreign government and commercial partners, which has enabled the pursuit of innovative science and rapid manufacturing scale. Most recently, Moderna’s capabilities came together to enable the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform is based on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and diseases. autoimmune. Moderna has been named a Top Biopharmaceutical Employer by Science for the past seven years. For more information, visit www.modernatx.com.

Forward-looking statements

East mail contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including: the development of the Company’s COVID-19 Vaccine (mRNA-1273, or Spikevax); the approval of the vaccine in children from 6 months to 5 years of age by the Administration of Therapeutic Goods; and the safety, efficacy, and tolerability of the vaccine in children 6 months to 5 years of age. The forward-looking statements in this Press release they are not promises or 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 in 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 to update or revise any forward-looking statements contained in this mail in case 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.

Modern Contacts

Media:
Lucas Mircea Willats
Director of Media Relations and Communications
[email protected]

Investors:
Lavina Talukdar
Senior Vice President and Director of Investor Relations
617-209-5834
[email protected]

FONT: modern, inc.

See source version at access cable.com:
https://www.accesswire.com/709014/Therapeutic-Goods-Administration-Grants-Provisional-Approval-for-Modernas-COVID-19-Vaccine-in-Children-Aged-Six-Months-to-Five-Years

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