Vaccine development Over 100 types of research in the world New coronavirus

Vaccine development Research more than 100 kinds in the world New coronavirus May 23 18:41

In the United States and the United Kingdom, research institutions and pharmaceutical companies are collaborating with each other to develop a vaccine for the new coronavirus.

According to WHO = World Health Organization, more than 100 kinds of new coronavirus vaccines are currently being researched in the world, and at least 10 of them are actually inoculated into humans to confirm their safety and efficacy. Clinical trials are starting.

Of these, the US pharmaceutical company “Modelna” and the NIH = National Institutes of Health are currently developing a vaccine that has undergone a first-stage clinical trial to confirm its safety. We have also obtained approval to proceed to the stage.

This July, we expect to inoculate more people and proceed to the final stage of clinical trials to confirm the effects.

The government of the United States has provided a large amount of financial support for the development of this vaccine, and the FDA (US Food and Drug Administration) has indicated a policy of special early approval. We have announced a plan to improve the mass production system.

Meanwhile, the University of Oxford, UK, is currently developing a vaccine under the auspices of the British government, which will begin a clinical trial on a scale of 1,000 people last month, and is expected to enter the final stage of development in the summer.

Regarding the production of this vaccine, AstraZeneca, a major pharmaceutical company headquartered in the United Kingdom affiliated with Oxford University, announced that it will be ready to supply this September.

According to the announcement, AstraZeneca says it will be able to produce 1 billion servings this year and will supply at least 400 million servings in September. This means that 100 million doses will be supplied to the UK.

In addition, AstraZeneca has received support of more than $ 1 billion (more than 107 billion yen) from the US Department of Advanced Biomedical Research and Development, and British media says that about 300 million times will be supplied to the United States ..

On the other hand, the results of clinical trials have not been released yet, and AstraZeneca may have failed in its development.

It is unusual for a mass production system to be put in place when the effects of the vaccine have not yet been proved, so that the vaccine can be promptly supplied to reduce the burden on the medical system while the epidemic is prolonged, and the economy can be reduced. It is expected that the impact on

Regarding the development of a new coronavirus vaccine, there is concern that it will be enclosed by developing countries, but AstraZeneca is working with WHO and others to work to ensure that the vaccine is evenly distributed throughout the world.

Early commercialization Some voices question

On the other hand, in the development of vaccines, it is necessary to carefully check the safety for serious side reactions, and some experts question the early commercialization.

If the vaccine is successfully developed, the order in which it will be supplied will also be an important issue.

Through the Department of Advanced Biomedical Research and Development, the U.S. government has provided over 100 billion yen in funding to modelers and pharmaceutical companies such as Johnson & Johnson, AstraZeneca, and Sanofi to support development and production systems. I will.

Against this backdrop, French pharmaceutical giant Sanofi's CEO said in an interview with a news agency that he "has the right to pre-order most in the US" because of funding from the Biomedical Advanced Research and Development Agency. , The French government has violently repudiated that "equal access to vaccines cannot be yielded", and there are fierce battles between countries with the vaccine in mind.

The WHO General Assembly, which closed this week, also adopted a resolution aiming to limit vaccine patents and provide cheap vaccines to developing countries. I did not agree with the resolution. "

The resolution is not enforceable, but it remains unclear how vaccines will be delivered to developing countries, where it is difficult to prevent the spread of the disease as the outbreak prolongs the economic impact.

Domestic human clinical trials expected to begin this summer

Even in Japan, major pharmaceutical companies, venture companies, and research institutes such as universities are working on development, and this week, the government has responded to four studies led by pharmaceutical companies and five studies led by research institutes such as universities. It was decided to subsidize about 7 billion yen in total.

It is expected that clinical trials to actually administer to humans will start in Japan as early as this summer.

Conventionally, vaccines have been manufactured by cultivating pathogens such as viruses using chicken eggs or animal cells and then eliminating or attenuating the toxicity, but because the virus itself is used, it has a high level. In addition to having to repeat the experiment in a facility equipped with the safety equipment of, and it takes a yearly time to increase the production of vaccine, because it takes time to culture.

Therefore, in order to shorten the development period, new coronaviruses are immunized by using a part of the virus gene that is relatively easy to increase and artificially made protein called “antigen”. Development of a vaccine using a new technology that causes the reaction of is also under way.

The biotechnology venture company "Anges" in Osaka, which was established in Japan based on the research of Osaka University, develops a vaccine by culturing by incorporating a part of the gene of the new coronavirus into a special DNA called "plasmid". Is proceeding.

We are investigating whether it is safe and whether antibodies against viruses are sufficient in animal experiments, and from this July we plan to actually administer it to humans and carry out clinical trials to confirm its safety and efficacy, which will be put into practical use next spring. It means that we are aiming for realization.

In addition, pharmaceutical giant "Shionogi Pharmaceutical Co., Ltd." cooperated with the National Institute of Infectious Diseases to utilize gene recombination technology to produce a protein with the same shape as that on the surface of the new coronavirus. Development is in progress.

In order to start clinical trials to administer to humans within the year, we are proceeding with coordination with the Ministry of Health, Labor and Welfare and others, and will strengthen the system for mass production so that it can be provided to 10 million people from next year. ..

In addition, biopharmaceutical company "ID Pharma" headquartered in Tokyo, in collaboration with the National Institute of Infectious Diseases and the research institutes of universities in Shanghai, uses a special virus called a vector for part of the gene of the new coronavirus. We are starting to develop a vaccine to be delivered.

A previous study with a research institute in Shanghai plans to start animal testing next month, and hopes to start a clinical trial to administer to humans next year.

In addition, the "KM Biologics" in Kumamoto City is developing various methods such as a vaccine that eliminates the toxicity of the virus, and a vaccine that reduces the toxicity of the virus at the Institute of Medical Science, the University of Tokyo.

Expert "Is at least one year before vaccination"

Regarding the prospect of developing a new coronavirus vaccine, Tetsuo Nakayama, a professor at Kitasato University who is familiar with vaccines, said, "The vaccine is currently in development and has not been shown to be effective in humans. Results of future clinical trials Depending on the situation, it may take at least a year before we can get the vaccine. "

In addition, regarding the development of new types of vaccines, such as "DNA vaccines" that use part of the viral genes to induce an immune response, he said, "Vaccines using new technologies can be rapidly mass-produced. It has the advantages of being easy to develop and is being developed all over the world, but vaccines are targeted at healthy people, and in addition to efficacy, safety evaluation is very important. However, there are things that can be understood only by using it for people, so it is necessary to carefully evaluate it. "

In addition, Professor Nakayama said, “Even if a good vaccine can be made in a foreign country, it may not be easily imported. Japanese may have different reactions to the vaccine, so it is important to be able to produce it domestically. That's it. "