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Interim data from the Phase 1/2 study led by Takeda shows that the immune response is consistent with the Moderna Phase 3 COVE study
Takeda will import and distribute 50 million doses; Distribution in Japan will begin immediately
Moderna, Inc. (Nasdaq:Ribonucleic acid), a biotechnology company pioneering messenger RNA (mRNA) therapy and vaccine technology, today announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has obtained emergency approval under Article 14-3 of the Drugs and Medical Devices Act. In Japan, Moderna The mRNA COVID-19 vaccine (now called the COVID-19 vaccine Moderna intramuscular injection). Takeda’s distribution in Japan will begin immediately.
Moderna continues to expand its business network; Moderna KK, the company’s commercial subsidiary in Japan, was established in April 2021. The company is actively recruiting locally.
“This is an important moment in Moderna’s history because this is the first approval of Moderna products in Japan. We would like to thank MHLW, research participants and Takeda for protecting the Japanese population from COVID-19 through our help. Vaccines “, Moderna CEO Stéphane Bansel (Stéphane Bancel) said. “We look forward to establishing our local team in Japan to continue to introduce mRNA science to meet other unmet medical needs.”
The approval is based on the results of Moderna’s Phase 3 COVE study and the positive initial clinical data led by Takeda Placebo control 1/2 stage Learn.This study is The aim was to evaluate the safety and immunogenicity of two intramuscular injections of the COVID-19 vaccine Moderna with a dose of 100 μg at 28-day intervals in 200 participants aged 20 and over in Japan. Preliminary results show that the immune response is combined with the results of the Phase 3 COVE study conducted by Moderna in the United States. In 100% of the participants, 28 days after the second injection of Moderna COVID-19 candidate vaccine, the titers of binding and neutralizing antibodies increased. Candidate vaccines are generally well tolerated and no major safety hazards have been reported. Participants will be followed up within 12 months after the second vaccination.
Before Takeda and Modern Announce that Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate from the first half of 2021. The two companies confirmed discussions in the Ministry of Health, Labour and Welfare report last week, stating that another 50 million doses may be supplied from early 2022.
Authorized use
Moderna’s COVID-19 vaccine has been approved for emergency use in adults over 18 years of age.
About Moderna
In the 10 years since its establishment, Moderna has transformed from a research-stage company with advanced plans in the field of messenger RNA (mRNA) to a company with a clinical portfolio of vaccines and therapeutic agents with six models and a broad portfolio of intellectual property rights. In fields including mRNA and lipid nanoparticle formulations, as well as integrated manufacturing plants capable of large-scale clinical and commercial production at an unprecedented speed. Moderna maintains alliances with many domestic and foreign government and business partners, which makes it possible to pursue pioneering science and the rapid scale of manufacturing. Recently, Moderna’s capabilities have merged to authorize one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform is based on the continuous advancement of basic and applied mRNA science, delivery technology and manufacturing, and has provided therapies and vaccines for infectious diseases, immune tumors, rare diseases, cardiovascular diseases and autoimmune diseases. Gave support. Today, 24 development plans are being carried out in these therapeutic areas, 14 of which have entered the clinic. For the past six years, Moderna has been named a top biopharmaceutical employer by Science magazine.To learn more, please visit www.modernatx.com.
Forward-looking statements
This press release contains forward-looking statements as defined in the revised Private Securities Litigation Reform Act of 1995, including statements regarding the approval of Moderna’s COVID-19 vaccine (mRNA-1273) by the Ministry of Health, Labour and Welfare of Japan. The distribution of the company’s COVID-19 vaccine in Japan; the company’s establishment of a commercial subsidiary in Japan and the employment of local personnel; the safety and immunogenicity of the company’s COVID-19 vaccine; and the potential for future sales of the COVID-19 vaccine to Japan.In some cases, forward-looking statements can be passed such as “will”, “may”, “should”, “may”, “expect”, “intend”, “plan”, “target”, “expect”, “,” “Believe”, “estimate”, “forecast”, “potential”, “continue” or the negative words of these terms or other similar terms, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither It is neither a promise nor a guarantee, and you should not rely too much on these forward-looking statements, because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Moderna’s control, which may cause actual results to differ from each other. The results expressed or implied by these forward-looking statements are very different. These risks, uncertainties and other factors include in particular: the fact that commercial products approved to use mRNA technology have never been used; the rapid response technology used by Moderna is still being developed and implemented Medium; The safety, tolerability and efficacy profiles of Moderna COVID-19 vaccine observed so far may be adversely changed after ongoing trial data analysis or commercialization; Moderna COVID-19 vaccine is effective against SARS-CoV-2 The effectiveness of the virus variants may be low, or the company may not be able to develop future vaccines against these variants; despite ongoing interaction with the FDA or other regulatory agencies, the FDA or other regulatory agencies may disagree with the company’s regulatory approval strategy , Whether the components of our documents (such as clinical trial design, behavior and methods) or the data submitted are sufficient; Moderna may experience delays in meeting production or supply schedules, or in its Moderna COVID-19 vaccine distribution plan There will be an interruption; whether and when it is possible to submit any biological product license application and/or other emergency use authorization application in various jurisdictions, and finally obtain the approval of the regulatory agency; the potential adverse effects caused by the global COVID-19 pandemic, Such as regulatory review, delays in manufacturing and clinical trials, supply chain disruptions, adverse effects on the medical system, and disruptions to the global economy; and Moderna’s latest annual report on Form 10-K submitted to the U.S. Securities and Exchange Commission (SEC) and “Moderna Other risks and uncertainties described under the heading “Risk Factors” in the follow-up documents submitted by the SEC are on the SEC website www.sec.gov. Unless required by law, Moderna assumes no intention or responsibility to update or revise any forward-looking statements contained in this press release when new information, future developments or other circumstances occur. These forward-looking statements are based on Moderna’s current expectations and represent only the situation as of the date of this article.
View the source code version on businesswire.com: https://www.businesswire.com/news/home/20210520006147/zh/
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