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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.
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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