As Olympics loom, Japanese approval of Moderna's COVID-19 vaccine unlikely till May
07/01/2021 10:37
* Japan has secured more than enough vaccine orders
* But Japanese rules mean vaccine approvals lag others
* Tokyo Olympics scheduled to start in late July
* Takeda Pharmaceutical handling Japan's Moderna rollout
By Rocky Swift
TOKYO, Jan 7 (Reuters) - Moderna Inc's MRNA.O 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.
urn:newsml:reuters.com:*:nL4N2IA2FS
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 4502.T , 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 VVAX.O
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 AZN.L is also being trialed in Japan, leaving
a shot developed by Pfizer Inc PFE.N and BioNTech 22UAy.DE
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. urn:newsml:reuters.com:*:nL4N2JI042
"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. urn:newsml:reuters.com:*:nL4N2IA2FS
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)
((rocky.swift@thomsonreuters.com))