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
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 About Moderna 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 Moderna Contacts: Investors: SOURCE: Moderna, Inc.
File: 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
01/11/2022 Dissemination of a Financial Press Release, transmitted by EQS News. |
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