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Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves Moderna’s COVID-19 Vaccine

May 21, 2021 Off By BusinessWire

Interim data from Takeda-led Phase 1/2 study indicates immune response consistent with Moderna’s Phase 3 COVE study

Takeda will import and distribute 50 million doses; distribution in Japan will begin immediately

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna’s mRNA COVID-19 vaccine, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan. Distribution by Takeda in Japan will begin immediately.

Moderna continues to scale its commercial network; the Company’s commercial subsidiary in Japan, Moderna K.K., was incorporated in April 2021. The Company is actively hiring locally.

“This is an important moment in Moderna’s history as it is the first approval for a Moderna product in Japan. We would like to thank the MHLW, the participants in the study and Takeda for helping to protect the Japanese population from COVID-19 with our vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to building our local team in Japan to continue to bring mRNA science to address additional unmet medical needs.”

The approval is based on Moderna’s Phase 3 COVE study results and positive initial clinical data from the Takeda-led placebo-controlled Phase 1/2 study. This study is designed to evaluate the safety and immunogenicity of two vaccinations of COVID-19 Vaccine Moderna Intramuscular Injection at the 100 μg dose level given 28 days apart in 200 participants aged 20 years and above in Japan. Initial results showed an immune response with results from Moderna’s Phase 3 COVE study conducted in the U.S. Binding and neutralizing antibody titers were elevated at 28 days after the second dose of the Moderna COVID-19 vaccine candidate in 100% of participants. The vaccine candidate was generally well tolerated with no significant safety concerns reported. Participants will be followed through 12 months after the second vaccination.

Takeda and Moderna previously announced that Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021. The companies have affirmed discussions reported by MHLW last week for an additional potential supply of 50 million doses from the beginning of 2022.

Authorized Use

Moderna’s COVID-19 vaccine is authorized for emergency use in adults aged 18 years 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 six 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 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. Today, 24 development programs are underway across these therapeutic areas, with 14 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.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 statements regarding the approval of Moderna’s COVID-19 vaccine (mRNA-1273) by the Japanese Ministry of Health, Labour and Welfare; the distribution of the Company’s COVID-19 vaccine in Japan; the establishment of a commercial subsidiary in Japan by the Company and the hiring of local personnel; the safety and immunogenicity of the Company’s COVID-19 vaccine; and the potential for future sales of COVID-19 vaccine to Japan. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. 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, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and 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 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.