Ministry of Health, Labour and Welfare in Japan Approves Partial Change to a New
Ministry of Health, Labour and Welfare in Japan Approves Partial Change to a New Drug Authorization for Moderna's Omicron-Targeting Bivalent Booster COVID-19 Vaccine, mRNA-1273.222
CAMBRIDGE, MA / ACCESSWIRE / November 1, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222 (Spikevax Bivalent Original/Omicron BA.4-5) in adults 18 years and older. Spikevax Bivalent Original/Omicron BA.4-5 contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant BA.4-5. mRNA-1273.222 now joins Moderna's BA.1 variant targeting vaccine, mRNA-1273.214, which was approved in Japan in September."COVID-19 continues to be a public health threat in Japan, with ongoing rates of infections driven by Omicron subvariants. mRNA-1273.222 is designed to provide broader and more durable immune response against Omicron BA.4-5, which are the main subvariants circulating in Japan," said Rami Suzuki, President & Representative Director of Moderna Japan. "We are grateful for this approval decision and are committed to bringing this vaccine to the people of Japan as soon as possible."
Moderna developed mRNA-1273.222 in accordance with U.S. FDA guidance to develop a BA.4-5-targeting bivalent vaccine. A Phase 2/3 trial for mRNA-1273.222 is currently underway. Takeda Pharmaceutical Co. Ltd. continues to provide distribution support for Spikevax Bivalent Original/Omicron BA.4-5 under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period.
Authorized Use
Spikevax Bivalent Original/Omicron BA.4-5 is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. One 0.5 mL dose is provided intramuscularly.About Moderna
In over 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 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 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 or https://jp.modernatx.com/.
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 development of the Company's COVID-19 Vaccine (mRNA-1273.222, or Spikevax Bivalent Original/Omicron BA.4-5); the breadth and durability of response against Omicron BA.4-5 from mRNA-1273.222; and the authorization of mRNA-1273.222 in adults ages 18 years and older by the Ministry of Health Labor and Welfare. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each 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 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.
CAMBRIDGE, MA / ACCESSWIRE / November 1, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.222 (Spikevax Bivalent Original/Omicron BA.4-5) in adults 18 years and older. Spikevax Bivalent Original/Omicron BA.4-5 contains 25 µg of mRNA-1273 (Spikevax) and 25 µg of a vaccine candidate targeting the Omicron variant BA.4-5. mRNA-1273.222 now joins Moderna's BA.1 variant targeting vaccine, mRNA-1273.214, which was approved in Japan in September."COVID-19 continues to be a public health threat in Japan, with ongoing rates of infections driven by Omicron subvariants. mRNA-1273.222 is designed to provide broader and more durable immune response against Omicron BA.4-5, which are the main subvariants circulating in Japan," said Rami Suzuki, President & Representative Director of Moderna Japan. "We are grateful for this approval decision and are committed to bringing this vaccine to the people of Japan as soon as possible."
Moderna developed mRNA-1273.222 in accordance with U.S. FDA guidance to develop a BA.4-5-targeting bivalent vaccine. A Phase 2/3 trial for mRNA-1273.222 is currently underway. Takeda Pharmaceutical Co. Ltd. continues to provide distribution support for Spikevax Bivalent Original/Omicron BA.4-5 under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period.
Authorized Use
Spikevax Bivalent Original/Omicron BA.4-5 is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. One 0.5 mL dose is provided intramuscularly.About Moderna
In over 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 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 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 or https://jp.modernatx.com/.
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 development of the Company's COVID-19 Vaccine (mRNA-1273.222, or Spikevax Bivalent Original/Omicron BA.4-5); the breadth and durability of response against Omicron BA.4-5 from mRNA-1273.222; and the authorization of mRNA-1273.222 in adults ages 18 years and older by the Ministry of Health Labor and Welfare. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022, each 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 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.