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 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.
Moderna did not immediately respond to an emailed request for
comment.
LOGISTICAL HURDLES
A COVID-19 vaccine developed by Oxford University and AstraZeneca
Plc is also being trialed in Japan, leaving a shot developed by
Pfizer Inc and BioNTech the only one currently under regulatory
review in the country.
Japan has arranged to buy 120 million doses each from Pfizer and
AstraZeneca. Through Takeda, it will secure 50 million doses of the
Moderna vaccine and up to 250 million of the Novavax formula.
Leaving regulatory hurdles aside, production arrangements and
logistical challenges could also complicate vaccine rollouts, as
Japan is gripped by a third wave of the pandemic that has been the
widest and deadliest yet.
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 New daily infections nationwide
have hit fresh records in recent days, exceeding
7,000 on Thursday. The prime minister has
declared a month-long state of emergency in
Tokyo and three neighbouring prefectures.
"To achieve the needed production volume, there are various
factories to be contracted and tech transfers to be done all over
the world," said Imagawa. "And whether that can all really come
together to secure enough supply is a remaining challenge."
Pfizer carried out combined Phase I and II trials of its vaccine
candidate in Japan in the autumn and said in late December it had
applied for approval in Japan for its vaccine, which at the time was
already being distributed in Britain and the United States.
Suga said he hoped administering the Pfizer shot could start by the
end of February.
AstraZeneca began Japan trials of its vaccine in September but has
not yet applied for approval, even as it was approved in India,
Britain, Argentina and El Salvador and filed to regulators in South
Korea and Mexico.
An AstraZeneca spokeswoman declined to comment on the vaccine's
approval or distribution timeline in Japan, citing confidentiality
with the government.
Takeda hoped to begin clinical trials of the Novavax candidate next
month and, upon approval, it would be mass produced at the company's
facility in Yamaguchi prefecture, Imagawa said.
(Reporting by Rocky Swift; Additional reporting by John Miller in
Zurich; Editing by Miyoung Kim and Edmund Blair)
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