KM Biologics (Kumamoto City), a pharmaceutical company, announced on the 6th that the safety of the new coronavirus vaccine under development has been confirmed and it is estimated that it will be more effective than the vaccine already in practical use.
The company plans to apply for approval to the Ministry of Health, Labor and Welfare in September by utilizing the “emergency approval system” that can shorten the procedure at the final stage. We are aiming for supply within 2022.
KM’s vaccine is a type called “inactivated vaccine” that uses a virus that has lost its infectivity and virulence. It is assumed that a total of 3 inoculations will be given to 18-40 year olds.
In an intermediate stage clinical trial in which about 2,500 people participated, the amount of neutralizing antibody after 3 inoculations was measured. Based on the data obtained here, it was found that in the final stage clinical trial starting in April, there is a probability of 99.9% or more exceeding the antibody level when AstraZeneca in the UK is inoculated twice. The effectiveness can be estimated. On the other hand, the frequency of side reactions was about the same as that of the seasonal influenza vaccine, and the safety was confirmed.