New coronary pneumonia: Accelerated vaccine development features six players running first in clinic-BBC News



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There are three main stages of vaccine research and development: laboratory-animal-clinical (human), finally approved by the regulatory authority, and then mass produced and put into use.Image copyright
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There are three main stages of vaccine research and development: laboratory-animal-clinical (human), finally approved by the regulatory authority, and then mass produced and put into use.

After the genetic sequence of the new SARS-CoV-2 coronavirus was announced in January 2020, the world began to compete in vaccine research and development. Three months later, more than 100 R&D projects were approaching the clinical stage. So far, 6 candidate vaccines have entered the first Human Clinical Trials.

From a technical point of view, there are those who follow the traditional path and also use genetic modification and technological innovation for editing, each with their own strengths and weaknesses.

It usually takes several years or even a decade to develop and promote a vaccine. The speed of research and development of a new vaccine is surprising.

But finding an effective vaccine and getting it approved for use by regulatory authorities does not mean success, and there are challenges such as mass production and distribution; The concept of mass production is that the number of vaccine agents is calculated in units of tens or billions, and the vaccine produced must be properly distributed to the target market to complete vaccination.

Each link is a challenge.

The 6 candidate vaccines currently in clinical trials are 3 in China, 2 in the US. USA And 1 in the UK.

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New development of China’s crown vaccine follows a more traditional route

Three vaccines from China entered clinical trials:

  • AD5-nCoV-Recombinant new coronavirus (adenoviral vector). Phase I clinical trials began on March 19, and 500 people are currently participating in phase II clinical trials.

This vaccine is a joint project between the company CanSino Biologics (China) listed in Hong Kong and the Institute of Military Medicine of the Chinese Academy of Military Sciences.

It belongs to the adenovirus vector vaccine and is constructed using genetic engineering methods. The principle is to allow the adenovirus to carry the pathogenic antigen of the new coronavirus into human cells, thereby synthesizing antibodies against the new coronavirus.

This technology is relatively mature and has been used to develop vaccines against the Ebola virus.

However, some studies have found that the success rate of adenoviral vector vaccines cannot be fully guaranteed, because the human immune system can cleanse the adenovirus injected into the human body as a vaccine, resulting in the inability of the body. to make new antibodies in the crown.

  • LV-SMENP-DC and pathogen-specific aAPC: two candidate vaccines from the Shenzhen Institute of Immunotherapy, the first is a lentiviral vector-modified dendritic cell vaccine, the second is a lentiviral vector-modified pathogen-specific vector Artificial cells presenting antigen.

These three candidate vaccines are based on viral vectors and are a more traditional type of multi-technology platform for the development of new corona vaccines. Such vaccines can provide high levels of protein expression, have long-term stability, and can induce a strong immune response.

The international professional organization Epidemic Prevention Innovation Alliance (CEPI) wrote in the journal Nature Review Drug Discovery that recombinant protein-based vaccine technology is relatively mature, and recombinant protein vaccines have been obtained for other diseases. license.

This also means that once such candidate vaccines have completed clinical trials, mass production can begin almost immediately.

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Traditional development of the vaccine virus, new methods using gene editing and modification technology.

Two vaccines in the United States entered clinical trials:

  • MRNA-1273-The first candidate for a new corona vaccine in the United States, based on mRNA (messenger ribonucleic acid) technology, different from the traditional route of vaccine development, avoiding the new coronavirus and writing directly in messenger ribonucleic acid.

The purpose of the vaccine is to train the human immune system to recognize the virus and defend itself when it encounters virus intrusion, to achieve the purpose of immunization.

However, mRNA-1273 does not use a virus to make a vaccine. A small part of the genetic code of the virus generated in the laboratory is injected into it. The same purpose is to stimulate the immune system response and fight invaders.

This vaccine research and development project began clinical trials on March 16, just 3 months after the announcement of the new coronavirus gene classification. The R&D team said 45 healthy adult men and women participated in the clinical trial, which ended on June 1, and the results will be announced in the summer.

This project was funded by the National Institutes of Health (NIH).

  • INO-4800, a new corona vaccine based on a DNA drug platform (deoxyribonucleic acid), was developed by the laboratory of the biopharmaceutical company Inovio in Santiago.

According to the Los Angeles Times, the company claimed to have designed the vaccine three hours after obtaining the viral gene sequence. Its goal is to directly inject DNA into human cells through a plasmid (a small genetic structure) to generate antibodies.

This biotech company is primarily engaged in the research and development of DNA drugs, and the new crown vaccine project is sponsored by institutions such as the Innovation Alliance for Epidemic Prevention (CEPI) and the Gates Foundation.

The two new crown vaccines that first entered clinical trials in the United States did not follow the tradition, but took a different approach, using gene modification and gene editing technologies.

The biggest advantage of this technology is that it is fast and convenient, as long as there is a sequence of viral genes, the antigen can be rapidly transformed. Moderna’s mRNA-1273 vaccine took just 3 months from the announcement of the new coronavirus gene sequence to the start of clinical trials, and the INO-4800 design took just 3 hours.

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The first vaccine is estimated to be approved for mass production after 12 or 16 months.

1 UK vaccine enters clinical trial

V acuna ChAdOx1-Joint research and development of the Jenner Institute and AstraZeneca of the University of Oxford. A clinical trial was launched on April 23, and the top six players entered the game no later than.

However, this is the first and only player in Europe to have entered clinical trials to date.

It is based on the development of adenovirus vector vaccines and the new coronavirus peak protein, and clinical trials have tested the effectiveness and safety of anti-infection. Clinical Phase III is scheduled to end this fall.

AstraZeneca said that if the research and development results prove to be effective, then this vaccine may provide limited use later this year, and production capacity will strive for tens of millions of doses.

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Once the vaccine has successfully completed clinical trials, it faces the challenges of mass production and distribution.

CEPI said there is currently no candidate vaccine that can guarantee the effect of vaccination.

This is because the effectiveness of the vaccine is affected by many factors, including different races, ages, and living environments, and people may respond differently to the vaccine, and accumulating these data requires a considerable amount of weather.

Furthermore, the game of national and international politics is also a variable that cannot be ignored.

Vaccine research and development competition is accelerating, and the main force of participation is also more diverse: from the laboratory to the clinic and society, the first to finish may not be able to laugh to the end.

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