eclaration of the global pandemic signaled the beginning of an unprecedented global race to develop COVID-19 vaccines and drugs. Japan’s rapid approval of a vaccine (in February 2021) while continuing development of other therapies can be viewed as a success. On the other hand, these efforts also illustrated the unpredictability of infectious diseases and the importance of preparing countermeasures for the unknown, in Japan as elsewhere, during “normal” times.

The timing and use of data from local (native) patients for regulatory approval remains an issue in Japan. The urgent nature of the pandemic required approval of these vaccines based on global efficacy and safety data, not necessarily including clinical data from a country’s own population; on the other hand, the standard J-NDA requires data from patients in Japan. One MAH (Marketing Authorization Holder) included data from patients in Japan in their application; all other applicants, upon PMDA request, began clinical trials in Japan during the application process and agreed to submit these data to PMDA as soon as these trials were completed. Discussions are planned to address new regulations for emergency authorizations or approvals in pandemic circumstances that will not require data from patients in Japan.

The need to discover and promote new modes of collaboration between academia, industry, regulators, and government remains essential, as these collaborations generate new seeds and enhance their growth for emerging research which may prove useful in the future. Academic research proved particularly important in the early stages of this pandemic, but a mechanism that connects these researchers with venture capital organizations for subsequent commercialization remains relatively rare in bringing these products to market in Japan. Unfortunately, COVID-19 vaccine development did not allow for the rapid commercialization of Japan’s “new seeds,” making it quite clear that cooperation between academia and fostering ventures is still an issue in Japan.

Academic and industry researchers in Japan have also learned that issues from this pandemic can help prepare for the inevitable necessity of providing drugs/vaccines as soon as possible in response to the next pandemic. Academic R&D in peacetime is very important for enabling development in emergencies. In addition, global collaboration between academic organizations may enable faster launch of infectious disease research projects.

From the industry association and manufacturer perspectives, this pandemic provided opportunities to explore new infectious disease treatment modalities (mRNA vaccines, virus vector vaccines, antibody cocktail products, etc.) without compromising product quality, safety, or efficacy. Industry has also learned that it can step into a larger role in communicating with the public in Japan, going beyond risk communication to more visibly promote public health education, including the neccesity of vaccination.

COVID also taught us the importance of considering the nonscientific or nonmedical aspects of a pandemic. Who is ultimately responsible for crisis management, or for the therapeutic product supply chain? Who communicates scientific information to the public? What crisis management systems are established, and how suited are they to global health issues? How strong are the government or political commitments to these systems?

In addition, the pandemic illustrated the importance of enhanced development of new products to combat infections; of collaboration among government, academia, and industry, both in Japan and globally, not only to alleviate the current pandemic but to prepare for the next one; and of prompt government action in real-world prevention and treatment.