New crown epidemic: 4.34 million! The US FDA granted Moderna's vaccine product mRNA-1273 fast track qualification and entered Phase III clinical trials in early summer!

2020 May 13 News /BioValleyBIOON / - The new crown pneumonia epidemic is spreading rapidly worldwideAccording to Baidu in "real timenovel coronavirus pneumonia outbreak of large dataReport", as of May 13th 11 2020, a total of over 4.34 million cases diagnosed, the cumulative foreign diagnosed more than 4.25 million cases, killed more than 288,000 casesUnited States confirmed a total of 2.93 million cases, 8.3 million deathsvaccine is considered to be the ultimate weapon against the new crown pneumoniaCurrently, there are a considerable number of enterprises to join the field of vaccine research and development, while Moderna is considered to be one of the most promising enterprises, which is a clinical stage biotechnology company in the United States, creating a messenger RNA (mRNA) therapies and vaccines, committed to create the next generation of transformative therapies for patientsrecently, Moderna mRNA vaccine company in the research (mRNA-1273) ushered in a major piece of good newsThe US Food and Drug Administration (
FDA) has granted fast-track this vaccine product qualification (FTD), the vaccine against the virus that causes COVID-19, that the new coronavirus (SARS-CoV-2 )It is worth mentioning that this is the Moderna company received the first four FTDPreviously, the company Zika virus vaccine (mRNA-1893), methylmalonic acidemia (MMA; mRNA-3704), propionic acidemia (PA; mRNA-3927) project also received FTD qualificationFast Track eligibility (FTD) aims to accelerate the development of drugs for serious diseases and rapid review to address key areas of serious medical needs unmet Investigational drug to obtain fast-track status, means that pharmaceutical companies may be more frequent interaction with FDA in the development stage, after submission of the listing application if they meet the relevant criteria are eligible for accelerated approval and priority review , there are also eligible for a rolling review Dr Moderna's chief medical officer TalZaks said: "The fast-track accreditation, reflected on the urgent need for a new coronavirus vaccine in a Phase I study waiting for the US National Institute of Allergy and Infectious Diseases (NIAID) led by on the occasion of the full set of clinical data, we are actively preparing for phase II and phase III clinical studies to continue to understand the potential of mRNA-1273 to protect against SARS-CoV-2's "
May 6, uS FDA has completed a review of the company mRNA-1273 experimental new drug (IND) application, allowing it to carry out phase II study is expected to begin soon Phase III study program Moderna being finalized, it is expected to begin in early summer 2020 US Department of Health and Human Services (HHS) under the Biomedical Advanced Research and Development Authority (BARDA) will support these planning studies, it will also support the late-stage clinical development projects and Moderna companies and strategic partners Lonza ( Lonza) production plant on the expansion of mRNA-1273 manufacturing scale upgrade mRNA technology in recent years, the rise of a new generation of vaccine technology, can respond quickly to outbreaks of epidemic diseases The potential advantages of mRNA method for preventive vaccines including the ability to combine multiple mRNA into a vaccine, quickly found to respond to a pandemic emerging threats, agile manufacturing platform nature of the design and production of vaccines from mRNA obtained Moderna has built a fully integrated manufacturing facility, the prospect technology platform implementations possible clinical data show, Moderna patented technology mRNA vaccine was well tolerated, capable of eliciting long-lasting immune response against viral antigens mRNA-1273 is an anti-SARS-CoV-2 mRNA vaccine may encode a fusion front forms stable virus spike protein (S protein) mRNA-1273 to play a role in the S protein, which is the key to a viral infection of the host cell, when the target is the coronavirus vaccine research and development over the last severe acute respiratory syndrome (SARS) coronavirus vaccine and the Middle East Respiratory Syndrome (MERS) It is worth mentioning that, mRNA-1273 series to choose from a Phase I clinical immunization spent only 63 days, the first clinical batch was completed in February 7, the first on March 16 subjects completed immunized Earlier this month, Moderna and Lonza (Lonza) signed a strategic cooperation agreement for 10 years in order to achieve mass production of mRNA-1273 Moderna and other future products (Biovalley Bioon.com) ORIGINAL: ModernaReceives FDA FastTrackDesignationformRNAVaccine (mRNA-1273) AgainstNovelCoronavirus