Japan insists on domestic clinical trials before vaccine rollout

Japan insists on domestic clinical trials before vaccine rollout

Covid-19 inoculation campaign delayed by Tokyo’s demand for Japan-specific data

A contentious requirement for Japan-specific trials has delayed the rollout of Covid-19 vaccines in Asia’s largest advanced economy and threatened the Tokyo Olympics.

Small clinical trials that demonstrate the vaccines generate a similar level of antibodies when used in Japan are the main outstanding condition for approval of the jabs from BioNTech/Pfizer and several other companies.

Japan’s demand for proof that safety and efficacy do not differ in the country means that it will not start vaccinations until the end of February — three months after the earliest rollouts and fewer than five months before the delayed Tokyo Olympics are due to start.

Olympic organisers said they were working on the assumption that athletes who participate in the Games will not have been vaccinated by the summer.