New Champions Vaccine Research And Development Promoted By "Business Opportunity": Global Competition But No Longer Available

MRNA vaccine has become a hot topic again.

In February 25th, Tianjin University announced that the team of Professor Huang Hai had successfully developed a new crown oral vaccine, but it has not been clinically validated. The SFDA also pointed out that the vaccine must be clinically validated.

A vaccine industry in Southern China told the twenty-first Century economic report that the mainstream vaccine development is still inactivated vaccine. The mRNA technology itself deserves attention. Whether the vaccine can be successfully developed still needs safety test. Oral vaccine is difficult to distinguish from any clinical trials. On the other hand, the development cycle of the vaccine itself is far from being near thirsty, but it still has a unique significance in terms of scientific research.

Professor Pasteur (Frederic Tangy), director of the Innovation Laboratory of the Institute of vaccines at the Pasteur Institute, also said that although mRNA developed vaccines quickly, this method has not been clinically validated, and the industrial manufacturing process is far from mature, unable to produce tens of millions of vaccine preparations required. The price of mRNA vaccine is probably far too high. In contrast, the development of measles vaccine as carrier vaccine is more feasible. Measles vaccine has been able to reach tens of millions of annual output, which has been verified effective vaccine, has been used in the history of human medicine for more than 40 years.

The mRNA vaccine simulates the process of natural virus infection, induces human cells to produce the same protein on the surface of the pathogen, and activates the human immune response, which is like building a "pharmaceutical factory" in the human body. However, it is necessary to enter clinical trials. According to the test cycle and patient's condition, the clinical trial cycle may range from several months to several years.

MRNA is hot, but the vaccine is still alive.

Moderna is a biopharmaceutical company founded in 2010. This private holding company in the United States has been developing human protein and antibody drugs as the core of the company since its inception, and is committed to developing mRNA based technology. Up to now, Moderna has many projects, including vaccines, involving three major areas, including infectious diseases, tumors and cardiovascular diseases.

Compared with the traditional inactivated vaccine, the mRNA vaccine has greatly reduced the previous research and development process because it bypassed the whole virus culture process. However, so far, it still stays at the theoretical level, and has not yet used this technology to achieve the real industrialization of vaccines.

The traditional method of inactivated vaccine requires the actual sample of the virus. Before putting it into the vaccine, scientists usually use special chemicals to inactivate the virus. When the virus is inactivated or weakened, it will be injected into the body as an alien invader or antigen, thereby stimulating the body's epidemic prevention system to prevent and control specific viruses.

The principle of "mRNA vaccine rapid response platform" is different. Such vaccines usually produce antigen proteins directly to prevent specific viruses. They use RNA or DNA to contain molecules that construct protein codes. This process reduces the development time, because scientists do not need to cultivate the whole virus.

But that does not mean that the vaccine is ready to come out. Zhang Lunan, director of Ai Wei Xin, once said that under normal circumstances, the vaccine was too late to invest in the epidemic. Now developing vaccines is largely preparing for the worst situation.

In terms of safety and feasibility, the mRNA platform still needs continuous testing. The genetic technology used by Moderna has not yet produced any approved human vaccine. Whether DNA vaccine technology or mRNA vaccine technology, even if the rapid synthesis and preparation, and shorten the examination and approval time, still can not bypass clinical trials.

In general, the 1 phase of the vaccine clinical trial looks at the safety and the 2 phase of the immunological reaction, that is, whether the human body can be vaccinated after the vaccination, to achieve prevention, and 3 phase to do a comparative study, and to observe the statistical difference. Among them, the number of 3 phase clinical trials is often in thousands of people, or even more, even in the 2 phase.

At present, in order to speed up the pace, in addition to shortening the appropriate time for approval, it is possible to consider some alternative indicators in the design of clinical programs, such as neutralization experiments in vitro.

R & D competition

However, under the impetus of huge potential benefits, agencies and enterprises at home and abroad are still racing in the field of vaccine research and development.

According to data analysis firms Statista analysis, the total global vaccine sales in 2019 amounted to 54 billion US dollars due to the increase in infectious diseases such as influenza, swine flu, hepatitis and Ebola virus, which almost doubled since 2014. The global vaccine market is expected to grow to US $60 billion this year. The outbreak raised the share price of vaccine manufacturers because investors saw business opportunities for these companies.

In fact, many countries in the West have stockpiles of vaccines or drugs. For example, influenza includes seasonal influenza and pandemic influenza. Many pandemic influenza vaccines or seasonal influenza vaccines are available in some countries. In case of influenza pandemic, it can be applied to people immediately, so as to prevent the spread of the virus.

At present, a number of enterprises and research institutes, including China CDC, Hangzhou State Key Laboratory, Professor Guo Yong of Microbiology Department of University of Hong Kong School of medicine, Johnson, microbes, Moderna, Ai Wei Xin biological pharmacy, have announced the launch of a new type of coronal virus vaccine research and development.

Local time in February 18th, the French pharmaceutical giant Sanofi group joined the development of a new coronavirus vaccine competition. The US Department of health and public service (HHS) said it would provide Senofi with funds to produce a coronavirus vaccine.

Senofi had previously worked to develop SARS vaccine. This time, Sanofi will restart the SARS vaccine research. A small company launched the study after the outbreak of SARS in early twenty-first Century, and Senofi later bought the company. After the SARS epidemic is over, the study is shelved, but will now be reopened as the starting point for the development of the new crown vaccine.

In addition, the new coronavirus gene sequence has 79.5% similarity with SARS. The industry believes that the development of new coronavirus vaccine can learn from the research of SARS vaccine.

Meanwhile, the US Department of health and public service announced that it will expand cooperation with Johnson subsidiary Yang Sen. Yang Sen research and development is developing a vaccine. It also needs to determine whether the previously tested drugs can be used for the new crown virus infection.

Inovio Pharmaceuticals, a biotechnology company in the United States, recently announced that its laboratory in Santiago, using its unique DNA drug development platform, has developed INO-4800, a vaccine capable of fighting against the new crown virus. At present, it is actively seeking cooperation and financial support to strive for the first phase of human clinical trials this summer.

The first draft of the draft COVID-19 vaccine recommended by the World Health Organization in February 18th showed that Inovio, Pharmaceuticals, French pharmaceutical manufacturer Sanofi, India pharmaceutical company Zydus Cadila, India Codagenix and Serum company, GeoVax/BravoVax, Janssen Pharmaceutical, University of Oxford, Clover Biopharmaceuticals, and Dozens of vaccines developed by Bio and dozens of other agencies or companies have been listed as vaccine candidates.

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