Establishment of an emergency regulatory approval system in Japan in response to the COVID-19 pandemic and challenges in developing domestically produced vaccines

Although ten vaccines against novel coronavirus infection (COVID-19) have been placed on the World Health Organization (WHO)’s emergency use list, no vaccine has been developed by Japanese pharmaceutical companies. As of March 2022, 10 billion doses of vaccines have been administered worldwide 2 years after the infection was declared a pandemic by the WHO. Japan lacks a system for approval of pharmaceuticals at the stage of presumed efficacy in emergencies, such as the COVID-19 pandemic. The absence of such an emergency approval mechanism is believed to have been a stumbling block to the rapid availability of urgently needed drugs. Further promotion of vaccine development in Japan will require comprehensive improvement of investment in the vaccine field, which is critically lacking from a long-term perspective.