A cross-border coalition of medicines regulators has begun exploring alternatives to large-scale clinical trials when it comes to evaluating the efficacy and safety of coronavirus vaccines, as it is becoming difficult for latecomers to secure enough study participants.
If the International Coalition of Medicines Regulatory Authorities finds other effective ways, drugmakers in Japan and other countries trailing the United States and European countries in COVID-19 vaccine development would be able to accelerate their development and production.
The authorization or approval of vaccines generally requires a large-scale clinical study with the involvement of tens of thousands of participants — in groups receiving a vaccine or a placebo — to assess their safety and efficacy by comparing their data.