Driven by the urgent need to speedily combat the COVID-19 epidemic, Japan plans to ease its famously stringent requirements on clinical trials of vaccines and other essential drugs, laying the groundwork for rapid approval when emergency need is deemed to be overwhelming.
The Ministry of Health, Labor, and Welfare (MHLW) plans to put in place a new system that would permit the emergency authorization of certain drugs and vaccines if they are deemed efficacious and safe in clinical trials conducted in other countries. It is unclear how that would be determined with precision. Under the proposal, approvals would be rescinded if additional data within a certain period does not confirm the initial findings.
Historically, Japan has required vaccines to undergo blind, placebo-controlled trials involving more than 30,000 volunteers. But with the Covid virus still raging, it is increasingly difficult—and ethically challenging—to find large numbers of unvaccinated volunteers and then ask them to forgo a shot of vaccines already available. And Japan does not currently have a system in place to allow authorization of vaccines and drugs for emergency use.
The moves are considered necessary as new variants of the virus challenge the efficacy of existing vaccines, and as the supply of vaccines produced by domestic Japanese firms remains limited.