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RPT-INSIGHT-How South Korea turbocharged specialty syringe production for COVID-19 vaccines

Thu 22nd April, 2021 12:00pm
(Repeats with no changes to text)
    By Sangmi Cha
    SEOUL, April 22 (Reuters) - It was 7:30 a.m. on Christmas
Eve when Cha Jung-hoon, South Korea's deputy minister for small
businesses, got a call from his boss to make an urgent
three-hour car trip to visit syringe maker Poonglim Pharmatech.
    The brief: work out how the government could convince and
aid Poonglim, which had only about 80 employees, to rapidly
scale up production of their low dead space (LDS) syringes, a
type of syringe designed to minimise the amount of a drug left
in the device after injection.
    "It might help us get more vaccines," Cha recalls
then-minister Park Young-sun telling him.
    Under fire in local media for not doing enough to secure
COVID-19 vaccines, South Korea's government had been reviewing
options to accelerate shipments and gain more supply.
Engineering a jump in LDS syringe output was an opportunity to
be seized, it concluded.
    The niche products were suddenly in huge demand globally
after it became apparent they could be used to squeeze out a
sixth dose from vials of Pfizer Inc  PFE.N  and BioNTech's
 BNTX.O   22UAy.DE  newly approved COVID-19 vaccine compared to
five doses with a standard syringe. 
    "It had come to our attention that Pfizer was looking for
LDS syringes...using LDS syringes automatically boosts vaccine
volume by 20%," Park told Reuters.
    Of South Korea's LDS syringe manufacturers, Poonglim was
singled out for special attention.
    Its products are the easiest of domestic models to use,
according to South Korean healthcare workers, comfortably
drawing six doses from a Pfizer COVID-19 vaccine vial and often
seven by an experienced hand. Poonglim also had its own patents.
    Thus was borne a strategy to tout Poonglim's syringes, jack
up production and in doing so help Pfizer increase supply of
what had just weeks earlier become the first COVID-19 shot to be
approved in Britain and the United States. 
    LDS syringes can also mean more profits for drugmakers as
most contracts are based on a regulatory-approved number of
doses to be extracted from each vial.
    In the weeks that followed, government officials brought in
the expertise of the country's biggest conglomerate, Samsung, to
help refit production lines, facilitate talks with Pfizer and
guide Poonglim through regulatory procedures, Poonglim's Vice
President Cho Mi-heui told Reuters in an interview. The ministry
of small businesses also helped arrange loans for Poonglim.
    It wasn't the first time that South Korea had moved
decisively in its fight against the coronavirus. Early on in the
pandemic, the country had won plaudits for aggressive tracking
and contact tracing.
    The government also had faith in its strategy of recruiting
big business to bring about rapid results for small firms,
having used similar tactics to boost production of face masks
and testing kits.
    LDS syringes have helped Pfizer gain regulatory permission
in some countries to relabel its vials as having six doses.
    That new label, in tandem with an expansion of and
improvements to production and the addition of more suppliers
and contract manufacturers, allowed Pfizer in January to raise
its projection for vaccine doses it can provide globally in
2021, from 1.3 billion to 2 billion. More recently it raised
that forecast to nearly 2.5 billion.
    Pfizer said in a statement to Reuters it had been able to
accelerate shipments in the first quarter to South Korea and
more than 30 other countries due to these improvements.
    Seoul announced in late February that shipments of the
Pfizer-BioNTech vaccine - of which it had ordered 26 million
doses directly from Pfizer - would begin arriving in March, six
months earlier than first scheduled.
    
    WIN-WIN
    Cha, the deputy minister for small business, said Poonglim
sent samples to Pfizer on Jan. 2 and the U.S. company came back
a week later with positive feedback. All in all, it took less
than two months from the day that he was told to travel out to
Poonglim to clearance for Poonglim's syringes by the U.S. Food
and Drug Administration.
    Pfizer said it does not have any commercial agreement with
Poonglim and declined to comment on any interactions with the
syringe maker.
    In South Korea, the government's quick action on LDS
syringes is being touted by President Moon Jae-in as a major
pandemic success story.
    Poonglim's annual production capacity has jumped more than
seven times in less than four months to 360 million and the firm
has become, according to the ministry of small businesses, one
of the world's largest makers of LDS syringes.
    The South Korean firm also now has an informal relationship
with Pfizer under which the U.S. drugmaker introduces potential
clients, allowing Poonglim to approach them and work out deals,
according to Cho.
    Poonglim this month signed a deal to provide Japan with 30
million syringes over the next six months, she added. Japanese
government agencies overseeing the COVID-19 response declined to
comment on their procurement policies.
    Cho also said Poonglim is in talks with clients in Europe
and the United States about supplying LDS syringes but declined
to elaborate further.
    Poonglim's product is also among LDS syringes featured in an
information pack for healthcare professionals prepared by
BioNTech. Other products on the list include LDS syringes made
by major manufacturers such as Becton Dickinson  BDX.N  and B.
Braun.
    BioNTech said its list of LDS syringes was compiled for
informational purposes and neither it nor Pfizer vouched for
their quality or provided a warranty.
    While South Korea's vaccination drive is proceeding more
slowly than campaigns in Britain or the United States due to
access to vaccines, its relative abundance of LDS syringes has
helped it give 1.77 million people or 3.4% of its population at
least one dose of a coronavirus vaccine.
    By comparison, Japan has managed vaccinations for 1.39
million, or 1.1% of its population despite starting its
inoculation campaign nine days earlier.
    Seoul also this month recommended that LDS syringes be used
for all COVID-19 vaccines, not just the Pfizer shot.
    
    SAMSUNG'S BRAWN 
    Poonglim was initially reluctant to work with the government
and Samsung when they offered help, fretting that the tech giant
might steal proprietary technology, according to Poonglim's Cho.
    But the conglomerate had worked wonders, she said. 
    Samsung Bioepis, Samsung's drug research arm, made
introductions to Pfizer and helped Poonglim navigate the process
to gain U.S. FDA clearance.
    Samsung Electronics  005930.KS  helped Poonglim tweak the
design of the syringe that made it not only easier to mass
produce but reduced the amount of vaccine wasted and made it
safer to use. It also helped retool Poonglim's assembly lines,
increasing automation to lift output capacity, she added.
    Samsung Bioepis referred Reuters' queries to Samsung
Electronics which declined to comment.
    Production capacity surged - from around 4 million LDS
syringes per month in December to 10 million by February and
then more recently with the construction of a new plant to 30
million a month.
    Employee headcount has also jumped to some 400 people.

 (Reporting by Sangmi Cha; Additional reporting by Michael Erman
in New York, Ludwig Burger in Frankfurt, Rocky Swift in Tokyo
and Joyce Lee in Seoul; Editing by Miyoung Kim and Edwina Gibbs)
 ((Sangmi.Cha@thomsonreuters.com; +82 2 3704 5646))
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