Moderna Inc’s COVID-19 vaccine is unlikely to win approval in Japan until May due to requirements for local clinical trials, the distributor said, casting doubt over a nationwide vaccination rollout before the summer Tokyo Olympics.
With an eye on the Olympics due to start in late July, Japan has secured rights to at least 540 million doses of COVID-19 vaccines from several Western developers, the biggest quantity in Asia and more than enough for its 126 million population.
But Tokyo faces a major regulatory bottleneck due to requirements for local clinical trials before requesting approval. Several other countries have fast-tracked the review process to expedite mass inoculations.
A Japanese trial of the Moderna vaccine, which has already won approval in the United States, Europe, Canada and Israel, is due to start this month.
Masayuki Imagawa, the head of the Japan vaccine business for Takeda Pharmaceutical Co, told Reuters it would likely take several more months to complete the trial and said securing approval in May was “the best case scenario”.
Takeda, Japan’s biggest drugmaker, is a critical component to Prime Minister Yoshihide Suga’s aim to have enough vaccines for the population by June before the Summer Games, currently scheduled to start on July 23.
The company is handling domestic approval and imports of the Moderna shot and local production of Novavax Inc’s vaccine, whose development and approval in Japan is further off.