A clinical trial of a coronavirus vaccine created by KM Biologics Co. is seen in a photo provided by the pharmaceutical company.

       The Mainichi Shimbun answers some common questions readers may have about coronavirus vaccines made in Japan.

       Question: Is it true Japan-made coronavirus vaccines will be allowed quicker approval procedures than originally planned?

       Answer: Yes. For a pharmaceutical company to get national government approval to use a vaccine it has developed, it must show the vaccine's efficacy at preventing symptoms in clinical trials on many people. Ordinarily, when a vaccine is administered, a protein called a neutralizing antibody that attacks viruses forms in the body. The national government decided procedures could be simplified if drug developers could prove this protein amount is the same or more than in existing vaccines at the stage before large-scale clinical trials.

       Q: How are procedures simplified, and how are the drugs proven effective?

       A: To determine in clinical trials whether a vaccine is effective, there is usually a group that receives the vaccine currently in development and a group receiving a placebo. Now, the state can approve a coronavirus vaccine without using placebos and with far fewer clinical trial subjects. Participant numbers would fall from the usual several tens of thousands of people to about 3,000.

       Q: There appear to be many vaccine types. Do they need to be the same type for us to compare them?

       A: Generally speaking, yes. For example, when determining a messenger ribonucleic acid (mRNA) vaccine's efficacy, we compare it with an earlier mRNA vaccine. But if the same vaccine type doesn't exist prior to a new one's development, this latest vaccine can be compared to other vaccine types.

       Q: Why were the procedure changes made?

       A: A high percentage of people in Japan have been vaccinated, making it difficult to find unvaccinated individuals to participate in clinical trials. We don't know when the coronavirus will spread again, and we cannot keep relying only on foreign-made vaccines. The government aims to accelerate the rate of new vaccines' evaluations so that Japan-made vaccines can reach the public sooner. Of course, there must also be precautions to avoid sacrificing safety for speed.

       (Japanese original by Hidenori Yazawa, Lifestyle and Medical News Department)

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