Photo/Illutration A government building housing the Ministry of Health, Labor and Welfare (Asahi Shimbun file photo)

Health authorities have drafted a report outlining a new clinical trial system that would boost domestic development of COVID-19 vaccines and could prove to be more ethical as well.

The health ministry and the Pharmaceuticals and Medical Devices Agency are considering adopting the new clinical trial procedures that do not involve giving placebos to test groups.

Officials said the new procedures can reduce the number of test participants needed from tens of thousands to as few as about 3,000 to ensure minimum safety requirements are met and to speed up vaccine development.

Under the new procedure, drug companies compare the number of neutralizing antibodies that prevent infections in blood samples from people who received shots of a candidate vaccine with those from recipients of authorized vaccines.

They would compare data across the same type of vaccine, such as mRNA vaccines.

The procedure has been discussed by an international organization of regulatory authorities, including the Japanese regulator.

Pharmaceutical company Shionogi & Co. and other domestic drug makers said they would use this method in their clinical tests.

Past trials have compared a vaccine’s effectiveness at preventing the onset of COVID-19 among people who received vaccines under development with those who received placebos.

When studying vaccine efficacy in the past, many participants and a lot of time were needed to collect enough samples from those who became infected and developed the disease.

At the same time, the past procedure poses an ethical problem in administering placebo jabs given that authorized vaccines have already been put into practical use.

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