Japan's Takeda says 'human error' caused contamination of Moderna
vaccines
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[October 01, 2021]
By Rocky Swift
TOKYO (Reuters) - Japan's Takeda
Pharmaceutical Co Ltd said on Friday that "human error" caused metal
contaminants to get into Moderna Inc COVID-19 vaccine doses, leading to
a recall.
Takeda, which imports and distributes the vaccine in Japan, and Moderna
said in a new report that a Spanish manufacturer discovered contaminants
in some vials in July, but supplies from the same production were
allowed to be shipped to Japan.
Japanese authorities in August suspended the use of three batches of
Moderna shots containing 1.63 million doses after being notified of the
contamination. Moderna conducted an investigation in partnership with
Takeda and Spanish manufacturer Rovi, which operates the plant where the
contamination occurred.

The new report said that the problem stemmed from "incorrect assembly
and was due to human error specific to visually misjudging the required
1mm gap between the star-wheel and the stopper" of machinery that put
the tops on vaccine vials.
A total of five, sequential lots of the Moderna COVID-19 vaccine
manufactured at Rovi between June 27 and July 3 were investigated. The
first three were shipped to Japan and later recalled after the discovery
of particles, later determined to be stainless steel, inside 39 vials.
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A Takeda logo is seen in its research hub in Cambridge,
Massachusetts, U.S., November 26, 2018. REUTERS/Julie Steenhuysen

But a fourth lot failed inspection after the
discovery of particles on July 2, and a fifth lot was also held back
by Rovi. The problems with Lots 4 and 5 were reported to Moderna,
Takeda and Japan's health ministry, but the first three lots were
released for use because they "had passed inspection and were not
considered to be impacted."
In fact the incorrect set-up "led to the issue persisting throughout
the series of five batches," the investigation showed.
Improved operating procedures and the use of a new precision tool
will help prevent the issue from recurring, the report said.
The companies and Japan's health ministry have said the particles of
stainless steel did not pose any additional health risk.
(Reporting by Rocky Swift in Tokyo; Editing by Kim Coghill)
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