Photo/Illutration A COVID-19 vaccine being drawn into a syringe at a Chiba Prefecture hospital in 2021 (Wataru Sekita)

In preparation for infectious disease outbreaks, the government decided on Feb. 18 to assess whether human challenge trials entailing exposure to viruses should be introduced for vaccine and drug development.

This initiative is included in a newly approved medical research plan.

Human challenge trials involve deliberately infecting healthy volunteers with viruses or other pathogens to observe disease progression and assess the effectiveness of potential drugs or vaccines.

These trials have been used in Europe and the United States for the development of vaccines against diseases such as cholera and typhoid.

Britain conducted these trials during the COVID-19 pandemic.

In Japan, the approval of domestically developed COVID-19 drugs and vaccines lagged several years behind that of foreign-made ones.

At an expert panel discussing the plan, Takaji Wakita, head of the National Institute of Infectious Diseases, stressed the need for human challenge trials to bring Japan’s vaccine clinical trials in line with international standards.

The World Health Organization has issued guidelines for conducting these trials safely.

However, concerns remain about deliberately causing an illness.

The government plan notes these concerns, saying that in considering the implementation of human challenge trials, it will conduct research and analysis of international trends while taking ethical and safety issues into account.

(This article was written by Natsumi Adachi and Kazuya Goto.)

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