After it was pointed out that the approval of vaccines for the new coronavirus was delayed compared to overseas, the Ministry of Health, Labor and Welfare began discussions toward the establishment of a system to urgently approve the use of vaccines and therapeutic agents.
The Ministry of Health, Labor and Welfare has applied "special approval" to the new coronavirus vaccine, which simplifies the examination procedure, but has it been approved in Japan since the time when the United States and the EU approved its use? It was about 5 months after the month.
In the United States, there is a system called "emergency use authorization" that allows special use in the case of a life-threatening emergency situation and there is no alternative vaccine or therapeutic drug, and the Ministry of Health, Labor and Welfare has decided to create a similar system. On the night of the 18th, we started discussions in the expert group.
In Japan, as a general rule, strict confirmation of efficacy and safety in clinical trials is a condition of approval, but under the new system, a certain degree of efficacy is recognized and the expected effects are secondary. If it is judged that the risk of reaction is exceeded, it is necessary to approve it for a limited time and then consider urgently approving its use.
The committee members commented, "It is essential to have a mechanism that allows us to stop using the product as soon as the risk exceeds its effect," and "it is necessary to explain to the public in an easy-to-understand manner what kind of process the use should be urgently approved." Was out.
The Ministry of Health, Labor and Welfare will conclude the conclusions by the end of the year, and if it decides to establish a system, it will submit the necessary amendments to the law to the ordinary session of the Diet next year.