Daiichi Sankyo, one of the pharmaceutical companies developing a domestic vaccine for the new coronavirus, is preparing to conduct a clinical trial of a domestically produced "mRNA vaccine" for thousands of people by the end of this year. I found out.
Domestic "mRNA vaccine"
This was revealed to NHK by Masayuki Hikita, general manager of Biologics, who is in charge of vaccine development at Daiichi Sankyo, a major pharmaceutical company.
Currently, all of the "mRNA vaccines" used in Japan have been developed overseas, but Daiichi Sankyo has begun clinical trials of domestically produced "mRNA vaccines" using its own technology.
According to Mr. Hikita, General Manager of Biologics, we are preparing to start a final stage clinical trial to administer the vaccine under development to thousands of people by the end of the year, and based on the results, we will apply for approval to the government.
Since there are vaccines that have already been put into practical use in the new coronavirus, large-scale clinical trials that compare the effects of administering fake vaccine-free drugs to tens of thousands of people are said to be ethically difficult. ..
For this reason, the company is examining the antibody level of the person who received the vaccine under development by a method called "non-inferiority test" to confirm that it is comparable to the vaccine that has already been put into practical use.
If approved, the factory in Saitama Prefecture will carry out mass production, which means that the production system is currently being improved.
Regarding vaccine development by domestic companies, bio-venture AnGes MG, Shionogi Pharmaceutical Co., Ltd., and pharmaceutical company KM Biologics have also started clinical trials.
Mr. Hikita, General Manager of Biologics Division, said, "We will put our efforts into practical use in 2022. Since" mRNA "can develop drugs at a very high speed, the new corona is the top priority now, but other things will be done in the future. We would like to promote development in the fields of vaccines, gene therapy, and oncology. "
Clinical trials by 4 domestic manufacturers
Domestic manufacturers developing the new corona vaccine have been conducting clinical trials to administer the vaccine under development to humans.
Of these, AnGes is conducting final-stage clinical trials on a scale of 500 people, and it is said that future large-scale trials will be based on the policy of the national regulatory body, Shionogi Pharmaceutical, Daiichi Sankyo, and KM Biologics. We are starting clinical trials for each.
In clinical trials of vaccine development, it is common to administer a vaccine under development and a fake drug that does not contain a vaccine called "placebo" to tens of thousands of people and compare their efficacy and safety. For example, Pfizer's vaccine has been clinically tested in more than 40,000 people.
However, since there are vaccines that have already been confirmed to be effective in the new coronavirus, it is said that there is an ethical problem in administering a fake drug for testing, and it has become an issue for the development of a latecomer vaccine internationally. I am.
For this reason, clinical trials that do not use placebo are being discussed in various countries, and methods for comparing the antibody levels of people who have received the vaccine under development with vaccines that have already been put into practical use are being studied.
Regarding this, PMDA = Pharmaceuticals and Medical Devices Agency, which examines drugs in Japan, said, "We will exchange opinions and give advice to vaccine developers based on the latest information based on the examination of the authorities of each country and WHO. I have. "