Therapeutic Goods Administration of Australia authorizes Moderna’s Covid-19 vaccine for children (6-11 years)

DGAP-News: Moderna, Inc. / Keyword(s): Miscellaneous
17.02.2022 / 06:20
The issuer is solely responsible for the content of this announcement.

Therapeutic Goods Administration of Australia authorizes Moderna’s Covid-19 vaccine for children (6-11 years)

CAMBRIDGE, MA /ACCESSWIRE/February 16, 2022/ 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 a interim registration for use of Moderna’s COVID-19 mRNA vaccine, Spikevax, 50 mcg dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 to 11 years old.

“The TGA clearance for the use of our COVID-19 vaccine in children aged 6-11 in Australia is a significant milestone for Moderna as it is the first regulatory clearance for the use of our vaccine in this age group. We are grateful to the TGA for their diligence and the Australian government for their continued confidence in our mRNA platform,” said Stephane Bancel, Chief Executive Officer of Moderna. “We are grateful to have the opportunity to provide protection against COVID-19 to this important age group, protecting children and allowing them to continue to live as normally as possible.”

Professor Robert Booy of the Immunization Coalition commented: “I welcome this decision by the TGA and look forward to increasing the uptake of childhood vaccination even further to ensure the protection of children and maximize school attendance.

Moderna’s vaccine has been studied in the ongoing “KidCOVE” Phase 2 study, a randomized, observer-blinded, placebo-controlled expansion study to assess safety, tolerability, reactogenicity and efficacy of two 50 µg doses of Spikevax (mRNA-1273) given to healthy children 28 days apart. The study population was divided into three age groups (6 to less than 12 years, 2 to less than 6 years and 6 months to less than 2 years).

Data submitted to the TGA demonstrated that vaccination of children 6 to less than 12 years of age with a primary series of 50 μg mRNA-1273 is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses compared to to that of individuals aged 18-25 in the Cove phase 3 study. The geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a 99.3% seroresponse rate. Two 50 μg doses of mRNA-1273 were generally well tolerated.

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

Moderna’s vaccine has already received regulatory approval for adults and adolescents in Australia. On August 9, 2021, the TGA granted provisional registration to the Moderna COVID-19 vaccine for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus in persons 18 years of age and older. On September 3, 2021, provisional registration was extended to persons aged 12 and over.

About Moderna

In the 10 years since its inception, Moderna has grown from a research-stage company advancing messenger RNA (mRNA) programs, to a company with a diverse clinical portfolio of vaccines and therapeutics in seven modalities , an extensive portfolio of intellectual property in areas such as mRNA and lipid nanoparticle formulation, and an integrated manufacturing facility that enables large-scale clinical and commercial production at unprecedented speed. Moderna maintains alliances with a wide range of domestic and foreign government and commercial collaborators, which has enabled the pursuit of both breakthrough science and rapid scale-up of manufacturing. Most recently, Moderna’s capabilities have come together to enable the licensed use and approval of one of the oldest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform leverages continuous advancements 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 autoimmune diseases. Moderna has been named one of Science’s Top Biopharmaceutical Employers for the past seven years. To learn more, visit www.modernatx.com.

AUTHORIZED USE

The Therapeutic Goods Administration (TGA) in Australia has granted interim registration for the use of Moderna’s COVID-19 mRNA vaccine, Spikevax, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people aged six and over.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including with respect to: the Company’s development of a vaccine against COVID-19 (mRNA-1273, or Spikevax); the ability of Spikevax to elicit a neutralizing antibody response in children similar to that in older populations and to protect against COVID-19; and the safety and tolerability profile of Spikevax. The forward-looking statements contained 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 within Moderna’s control and which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks, uncertainties and other factors include the risks 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 subsequent documents written 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 the forward-looking statements contained in this press release 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:
Luc Mircea Willats
Director, Corporate Communications
[email protected]

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

THE SOURCE: Moderna, Inc.

17.02.2022 Broadcast of a Corporate News, transmitted by the DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

DGAP distribution services include regulatory announcements, financial/corporate news and press releases.
Archive at www.dgap.de

Comments are closed.