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Therapeutic Goods Administration of Australia Authorizes Moderna’s Covid-19 Vaccine in Children (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
[email protected]
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
[email protected]
SOURCE: Moderna, Inc.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comModerna, 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.
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Myanmar Government Approved USD 3.82 Billion in Foreign Investment and USD 651 Million in Domestic Investment in First Year of State Administration Council
The Ministry of Information (MOI) and the Ministry of Investment and Foreign Economic Relations (MIFER) released the latest investment figures for the country for the period between 1 February 2021 - when a Proclamation was issued - and 20 January 2022.
The SAC was formed on 2 February 2021, a day after the Proclamation was issued after the failure to settle the issue of voter list fraud and malpractices in the 8 November 2020 elections, and to postpone parliament sessions. A state of emergency was declared in accordance with Article 417 of the 2008 Constitution of Myanmar.
Despite destruction of public property, attacks on Government personnel and attempts to sabotage the domestic economy by the so-called People's Defense Force - with clear support from foreign elements - the SAC had largely restored national stability by the second half of 2021.
Myanmar faced a second crisis, a health pandemic that arose from the outbreak that was first detected in the country in March 2020. However, due to intense efforts to contain COVID-19, schools, universities have reopened, and most commercial activities have resumed in recent months with the vaccination of at least 60% the country's population (above 18 years) to date.
The MOI and MIFER said among the 50 domestic (citizens') investments approved in the past year, seven were for projects in the services sector with investment value of USD 427.34 million equivalent and 29 were for manufacturing projects with investment value of USD 74.58 million equivalent. The mining, power and construction sectors also attracted sizeable citizens' investments during this period.
Foreign investments approved in the past year included a USD 2.5 billion project to construct a liquefied natural gas (LNG) power plant, the two Ministers said.
The People's Republic of China (PRC), apart from being the largest trading partner of Myanmar, is the largest foreign investor in the country. Among the non-PRC foreign investments approved in the past year were one from Japan (USD 516.43 million), four from Singapore (totaling USD 442.20 million), two from Thailand (totaling USD 75.50 million) five from South Korea (totaling USD 66.17 million) and seven from Hong Kong (totaling USD 60.09 million).
The Government estimates that the foreign investments over the past year led to the creation of 25,383 new jobs while domestic investments added a further 11,879 new jobs, or a total of 37,262 jobs.
Myanmar Government is accelerating efforts to improve trade flows with and investments from countries such as Russia that, until recently, have not been among its leading economic partners. Prior to the pandemic, which curtailed business travel and activities, Myanmar-Russia bilateral trade had increased 30% in FY2019-2020 (November to October) compared to the year earlier.
Despite the challenges of the pandemic Myanmar and Russia are actively formulating a Bilateral Strategy for Development of Economic Cooperation. The latter has already led to a first virtual business matching session attended by dozens of business leaders from both countries last September. A second such virtual session will be held on 31 January 2022.
The two countries, which signed an Inter-Governmental Joint Commission for Trade and Economic Cooperation in August 2014, plan to hold its third Joint Commission meeting, physically, in Nay Pyi Taw in the near future.
Russian corporations have invested USD 94 million in Myanmar, mostly in the oil and gas sector, and the country currently ranks 22nd out of 52 foreign investors. Myanmar Government will support the extension of Russian investment interest to sectors such as mineral processing, solar energy, railway and ICT, aviation, automobiles and tourism.
"Economic recovery is a major priority as the country recovers from two crises and prepares for multi-party elections to be held by August 2023," said MOI Minister Mr. Maung Maung Ohn and MIFER Minister Mr. Aung Naing Oo in their joint statement.
"Due to good weather, Government financial support such as concessionary loans, and the relatively low impact of the pandemic compared to other sectors, the agriculture, fisheries and livestock sectors are reporting healthy growth. As workers return to workplaces in the past few months, the influx of new domestic and foreign investments will also contribute to job creation," they said.
These factors along with national stability and improved vaccination rates will help Myanmar register a modest economic recovery in 2021-2022 after a single-digit contraction of its Gross Domestic Product in 2020-2021 - which is less dire than forecasts of some international economists.
"While certain quarters of the international community publicly discourage economic cooperation with Myanmar, the country continues to record substantial trading volume as well as domestic and foreign investments. Many of our foreign partners choose to work quietly with us, fully recognizing Myanmar's economic potential as well as its unique challenges," the two Ministers said.
"We have shared with foreign partners our efforts to deal with economic sabotage in the form of attempts to boycott Government revenue, shake confidence in financial institutions and destabilise the kyat. Despite these challenges, our Ministries and Government departments have been working diligently away from public glare to increase trade and investment flows," they added. "These efforts have clearly borne fruit and we seek to increase such activities domestically and with foreign partners."
* All equivalents based on exchange rate of approximately USD1.0 to 1,771 kyat as at 26 January 2022.
Issued by Ministry of Information, Union Government of Myanmar
Please see https://www.moi.gov.mm/moi:eng/announcements/5962
Contact [email protected] or [email protected].
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comThe Myanmar Government said today it has approved USD 3.82 billion of foreign investments and USD 651 million equivalent(1) in domestic investments in first year since the State Administration Council (SAC) took office. The investment commitments underscore confidence in the country's economic potential amid a return to national stability and efforts to increase vaccination rates to contain the COVID-19 pandemic.
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