Japan firm KM Biologics to seek vaccine approval in September

The Yomiuri Shimbun

15:39 JST, July 7, 2022

KM Biologics Co. plans to file an application with the Health, Labor and Welfare Ministry for approval of its under-development novel coronavirus vaccine in September, at the earliest, the company said Wednesday.

The Kumamoto-based pharmaceutical company said it will use the so-called urgent approval system, which shortens the final stage of the approval process, with the aim of supplying the vaccine by the end of fiscal 2022.

KM Biologics said its COVID-19 vaccine has been confirmed to be safe and is presumed to be more effective than vaccines already in practical use.

The company’s product is an inactivated vaccine that uses a noninfective, nontoxic virus, and is planned to be administered three times to 18-to-40-year-olds.

About 2,500 people participated in the interim clinical trial, which started in April and measured levels of neutralizing antibodies after three inoculations. Based on data from the final phase of testing, it was found that test participants had a 99.9% probability of having higher levels of neutralizing antibodies than people who had received two doses of the AstraZeneca vaccine. As a result, KM Biologics’ vaccine is presumed to be effective, the company said. KM Biologics added that the frequency of adverse reactions was about the same as that of seasonal influenza vaccines, further underlining the product’s safety.