Kumamoto City's vaccine maker, KM Biologics, said it would apply to the government for approval of the new coronavirus vaccine under development next month, but it will wait for the final data from clinical trials to be collected, so the application will be delayed from December onwards. has been postponed to
The new corona vaccine that KM Biologics is developing is a type of "inactivated vaccine" that eliminates the toxicity of the virus, unlike the one that has been put into practical use in Japan.
Last month, the company announced that it would apply for approval to the government in September, saying that sufficient efficacy could be expected from preliminary results of clinical trials, and that it would utilize the government's emergency approval system for the application.
However, according to "Meiji Seika Pharma", which is jointly developing a vaccine with KM Biologics, last month, a council of the Ministry of Health, Labor and Welfare said, "Effectiveness of the new corona drug, which Shionogi & Co., Ltd. has applied for approval under the same system. It was decided that it would be difficult to obtain approval unless the final data from the clinical trial were available. .
For this reason, we will postpone the approval application for the vaccine next month and postpone it after December.
On the other hand, the policy of aiming to start supply within the fiscal year remains unchanged.