Why can Moderna’s COVID-19 vaccine stand out?

Why can Moderna’s COVID-19 vaccine stand out?  The COVID-19 virus has ravaged the world for more than a year, causing millions of deaths and a halt in global social and economic activities. Global medical professionals are also fighting day and night, and finally successfully developed a safe and effective vaccine for epidemic control within a year. This kind of response speed can be said to be unique in the history of medicine. It reflects not only the close cooperation of government, enterprises, health care institutions, and scientific research institutions, but also the perfect value display of solid platform technology in meeting the needs of medicine.

Judging from the results published so far, the mRNA vaccines launched by emerging biotechnology companies represented by Moderna have great advantages in terms of safety, effectiveness and production costs. People can’t help but sigh that it is a biotechnology company that has not yet started in this public health crisis and led a revolution in vaccine technology.

Judging from the statistics published by the WHO in June 2020, there are hundreds of new coronavirus vaccines under development worldwide, especially subunit vaccines, including recombinant proteins, non-replicating viral vectors, mRNA, replicable viral vectors, and DNA Or VLP, of course, there is a certain proportion of inactivated virus vaccines.

From the perspective of product development, the production process of recombinant protein, VLP, virus or DNA vector vaccine, and inactivated virus vaccine is complex, from molecular construction, preclinical proof of concept, cell culture-based production process development, clinical trials to drug supervision Obviously, the time required for the approval of the agency and the batch supply to the market is difficult to meet the social expectations of the current epidemic.

Based on the technology accumulation in the development of mRNA drugs, Moderna produces vaccines in a simpler, almost purely chemical way, which effectively speeds up the development of COVID-19 vaccines.

Moderna is a start-up technology platform company dedicated to drug development based on modified mRNA technology. The starting point of the company’s establishment is to solve the problems of long cycle, high cost and complex quality control in the production of protein drugs. It is expected to use in vitro biochemical methods to produce mRNA templates for manufacturing proteins, using the human body as an active protein production factory, based on protein drugs. The method of treatment has brought revolutionary changes.

At the beginning of the company’s establishment, the main focus was on the technology development of mRNA synthesis in vitro, chemical modification, and lipid encapsulation delivery to improve mRNA production, in vivo and in vitro stability, cell entry efficiency, protein production efficiency, and reduction of the body Immune rejection of drugs. At the same time, combined with the introduction of technology, we will strive to create a smart harbor that includes technologies, patents and talents related to mRNA drug development.

Ideal is plump, reality is skinny. In the early days of the company’s start-up, like other biotech companies, it experienced the spiraling upsurge of technology research and development. In the Boston area where there is a lot of money, start-up companies, and new technologies or product concepts emerge endlessly, Moderna has also experienced funding. , Human resources, and resources, especially in the field of biotechnology, which relies on end-of-life therapeutic products to embody technical value, is facing tremendous product development pressure.

Even so, Moderna still insists on continuously improving its technical system, and has completed various basic technical systems from scientific ideas to products in mRNA chemical modification, secondary structure simulation optimization, industrial production systems, drug delivery system development, quality control, and clinical development. The successful transformation of commercial production, and through project cooperation with large and medium-sized pharmaceutical companies such as Merck, AstraZeneca, Alexion, Vertex, etc., continue to verify and improve their technical capabilities in vaccines, fusion proteins, therapeutic antibodies, and recombinant enzymes.

It is through these project cooperation that the mRNA drug technology has been continuously expanded to infectious diseases, tumors, cardiovascular diseases, metabolic diseases, rare diseases and other medical fields, and the value of the technology platform has been realized. It is the continuous improvement and maturity of the technological system that has enabled Moderna to gradually become a star biotech company. It is one of the few biotech start-ups that have been valued at over US$5 billion before the IPO in recent years.

Moderna stands out in this vaccine development competition to fight the COVID-19 epidemic. There is this timeline:

• January 2020: The epidemic spread and became a global public health security issue;
• January 11, 2020: Announcement of the new coronavirus genome sequence;
• January 13, 2020: Moderna is mobilized to start the research and development of the COVID-19 vaccine;
• February 7, 2020: The production of the first batch of clinical-grade mRNA vaccines was completed and entered the quality control inspection stage;
• February 24, 2020: The mRNA vaccine product was delivered to the National Institutes of Health (NIH) to initiate clinical trials;
• March 16, 2020: The first phase of clinical trial for safety assessment was officially launched in 45 healthy people;
• May 29, 2020: Initiated a phase II clinical trial for the purpose of evaluating the immune effect in 600 volunteers;
• July 27, 2020:  Initiated a randomized, double-blind phase three clinical trial for the purpose of verifying safety and immune protection in 30,000 volunteers;
• August 11, 2020: Moderna promises to supply at least 100 million doses of vaccines (with the capacity to produce 800 million-1 billion doses);
• November 16, 2020: The preliminary results of Phase III clinical trials were released, and the vaccine protection efficiency reached 94.5%;

It only took 62 days from obtaining the viral gene sequence to launching the first phase of clinical trials. Such a product development speed is an inevitable result of Moderna’s commitment to the development of the platform technology system. As Moderna president Stephane Bancel said, they are a technology company, but fortunate enough to use their technology to solve a biological problem.

(source:internet, reference only)

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