The US FDA Granted Moderna's Vaccine Product MRNA-1273 Fast-track Qualification And Entered Phase III Clinical Trials In Early Summer!

- May 25, 2020-

The new coronary pneumonia epidemic is spreading rapidly around the world. According to Baidu's "Real-time Big Data Report on the New Coronavirus Pneumonia Epidemic Situation", as of 11:00 on May 13, 2020, there have been more than 4.34 million cases diagnosed globally, more than 4.25 million cases diagnosed abroad, and more than 288,000 deaths. A total of 2.93 million cases were diagnosed in the United States, with 83,000 deaths.


The vaccine is considered to be the ultimate weapon against new coronary pneumonia. At present, quite a few companies have invested in the field of vaccine research and development, and Moderna is considered to be one of the most potential companies. This is a clinical-stage American biotechnology company that has pioneered messenger RNA (mRNA) therapy and vaccines To create the next generation of transformative therapy for patients.


Recently, Moderna's mRNA vaccine (mRNA-1273) is welcoming a great news. The US Food and Drug Administration (FDA) has granted this vaccine product Fast Track Qualification (FTD), which targets the virus that causes COVID-19, the new coronavirus (SARS-CoV-2). It is worth mentioning that this is also the fourth FTD obtained by Moderna. Previously, the company's Zika virus vaccine (mRNA-1893), methylmalonic acidemia (MMA; mRNA-3704), and propionic acidemia (PA; mRNA-3927) projects also received FTD qualifications.


The Fast Track Qualification (FTD) is designed to accelerate the development and rapid review of drugs for serious diseases to address serious unmet medical needs in key areas. Obtaining fast-track qualifications for research drugs means that pharmaceutical companies can interact with FDA more frequently during the R & D phase. After submitting marketing applications, they are eligible for accelerated approval and priority review if they meet the relevant standards. In addition, they are also eligible for rolling review.


Dr. Tal Zaks, Chief Medical Officer of Moderna, said: “Quick-track qualifications reflect the urgent need for a new coronavirus vaccine. Awaiting the full set of clinical trials for the Phase I study led by the National Institute of Allergy and Infectious Diseases (NIAID) At the time of the data, we are actively preparing for phase II and phase III clinical studies to continue to understand the protective potential of mRNA-1273 for SARS-CoV-2. "


On May 6, the US FDA has completed the review of the company's mRNA-1273 experimental new drug (IND) application, allowing it to conduct Phase II studies, which is expected to begin soon. Moderna is finalizing the plan for the Phase III study, which is expected to begin in early summer 2020.


The Biomedical Advanced Research and Development Agency (BARDA) under the US Department of Health and Human Services (HHS) will support the planning of these studies, as well as support later clinical development projects and Moderna and strategic partner Lonza production plants About the expansion and upgrading of mRNA-1273 manufacturing scale.

mRNA-1273

mRNA technology is a new generation of vaccine technology that has emerged in recent years and can respond quickly to epidemics. Potential advantages of the mRNA approach for preventive vaccines include the ability to combine multiple mRNAs into one vaccine, rapid discovery to respond to emerging pandemic threats, and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has established a fully integrated manufacturing plant, making the prospect of the technology platform possible.


Clinical data shows that Moderna's patented mRNA vaccine technology is well tolerated and can cause a persistent immune response against viral antigens.


mRNA-1273 is an anti-SARS-CoV-2 mRNA vaccine that encodes a pre-fusion stable form of the viral spike protein (S protein). mRNA-1273 plays a role against S protein, which is the key to virus infection in host cells, and was also the target of the past development of severe acute respiratory syndrome (SARS) coronavirus vaccine and Middle East respiratory syndrome (MERS) coronavirus vaccine. It is worth mentioning that mRNA-1273 took only 63 days from sequence selection to phase I clinical immunization. The first clinical batch was completed on February 7 and the first subject completed the injection on March 16. .


Earlier this month, Moderna and Lonza signed a 10-year strategic cooperation agreement to achieve large-scale production of mRNA-1273 and other future products of Moderna.