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

Therapeutic Goods Administration of Australia Authorizes Moderna’s Covid-19 Vaccine in Children (6-11 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 50 ug dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years.

“The TGA authorization for the use of our COVID-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group. We are grateful to the TGA for their diligence and the Government of Australia for its continued confidence in our mRNA platform,” said Stephane Bancel, Chief Executive Officer of Moderna. “We are grateful for the opportunity to provide protection against COVID-19 to this important age group, keeping children safe and able to continue life as normally as possible.”

Professor Robert Booy from the Immunisation Coalition commented, “I welcome this decision by the TGA and look forward to the uptake of vaccination in children increasing even more to provide protection of children and maximize school attendance.”

Moderna’s vaccine was investigated in the ongoing Phase 2 “KidCOVE” study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of two 50 ug doses of Spikevax (mRNA-1273) given to healthy children 28 days apart. The study population was divided into three age groups (6 to under 12 years, 2 to under 6 years, and six months to under 2 years).

Data submitted to the TGA demonstrated that vaccination of children 6 to under 12 years of age with a 50 ug mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18-25 years old from the Phase 3 Cove 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 seroresponse rate of 99.3%. Two 50 ug 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), 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 (HHS). The ClinicalTrials.gov identifier is NCT04796896.

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

About Moderna

In 10 years since its inception, Moderna has transformed from a 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 both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking 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.

AUTHORIZED USE

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

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 regarding: the Company’s development of a vaccine against COVID-19 (mRNA-1273, or Spikevax); the ability of Spikevax to trigger a neutralizing antibody response in children similar to that in older populations and to protect against COVID-19; and the safety and tolerability profile for Spikevax. 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 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 lings 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 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:
Luke Mircea Willats
Director, Corporate Communications
Luke.Mirceawillats@modernatx.com

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

BAN ON CHINESE GOODS


There have been some representations/suggestions from public and industry to boycott the import of Chinese goods citing strained relations with China.  In June 2020, a representation was also received from a Member of Parliament calling for banning/boycotting of all Chinese goods in light of developments at Line of Actual Control (LAC) in Ladakh.


The Government of India, from time to time, takes appropriate measures to regulate import of goods including those related to national interest.  India and China are both members of the WTO and any trade restriction imposed must be WTO compliant.  Government has from time to time reviewed and taken WTO compliant measures (both policy and trade remedies) to address the concerns raised by various stakeholders to have a holistic global trade strategy.  To support and expand domestic capacities, Government has implemented policies to promote domestic manufacturing like the production linked incentive (PLI) schemes in line with Atmanirbhar Bharat policy.


This information was given by the Minister of State in the Ministry of Commerce and Industry, Smt. Anupriya Patel, in a written reply in the Lok Sabha today.


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Hong Kong – Dangerous Goods (Miscellaneous Amendments) Bill 2021 to be gazetted on Friday

Dangerous Goods (Miscellaneous Amendments) Bill 2021 to be gazetted on Friday

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     A spokesperson for the Security Bureau said today (June 30) that the Government will publish the Dangerous Goods (Miscellaneous Amendments) Bill 2021 (the Bill) in the gazette this Friday (July 2). The Bill seeks to make technical consequential and related amendments to various ordinances and subsidiary legislation pursuant to the legislative amendments made to the Dangerous Goods Ordinance (Cap. 295) (the Ordinance) and its subsidiary legislation.
 
     The spokesperson said, “To update the regulatory system of dangerous goods with a view to aligning it with the international standards, we have reviewed the Ordinance and its subsidiary legislation and have been making legislative amendments by phases. With the completion of our phased legislative amendment work to the Ordinance and its subsidiary legislation, we now enter into the final phase of legislative work. As various ordinances and subsidiary legislation involving different regulatory authorities contain references to dangerous goods classified under the existing classification system under the Ordinance and other matters in relation to the storage, conveyance and use of dangerous goods under the Ordinance, technical consequential amendments and other related amendments have to be made to these ordinances and subsidiary legislation so as to avoid inconsistencies among legal provisions on the implementation of the new dangerous goods classification and regulatory regime under the Ordinance.
 
     “We will also take the opportunity to introduce refinements to the Ordinance. As international standards on the classification and transportation of dangerous goods are updated regularly, the Bill proposes to empower the Secretary for Security to amend the Schedules to regulations made under the Ordinance so as to streamline the process for regular updating of the technical details of the subsidiary legislation (such as the list and exempt quantity of dangerous goods) in future. Similarly, the Bill proposes to remove the requirement that the forms of licences have to be provided by regulations, and to empower public officers who may issue licences to specify the forms of licences for administrative convenience.”
 
     The Government will introduce the Bill into the Legislative Council on July 14 for First and Second Reading.