TOKYO — Moderna Inc. and Takeda Pharmaceutical Co
Ltd on Wednesday said they are working with Japanese authorities to recall
three batches of COVID-19 vaccine after an investigation found stainless steel
contaminants in some vials.
اضافة اعلان
Japanese authorities had suspended use of these batches of
Moderna shots containing 1.63 million doses last week after being notified of
the contamination issue.
Japan's health ministry said on Wednesday, based on
information from the companies' investigation, that it did not believe the
particles of stainless steel pose any additional health risk. Moderna said the
stainless steel contamination probably occurred during production.
Takeda distributes the
Moderna vaccine in Japan.
The most probable cause of contamination was related to
friction between two pieces of metal in the machinery that puts stoppers on the
vials, Moderna said in the joint statement with Takeda. The material was
confirmed to be stainless steel.
Moderna conducted its investigation in partnership with
Takeda and Spanish manufacturer Rovi, which operates the plant where the
contamination occurred.
"Stainless steel is routinely used in heart valves,
joint replacements and metal sutures and staples. As such, it is not expected
that injection of the particles identified in these lots in Japan would result
in increased medical risk," Takeda and Moderna said in a joint statement.
Moderna shares were up 2.6 percent following the statement.
Shares of Rovi were up than 4.5 percent after falling more than 10 percent on
news of the dose suspensions. Takeda shares rose more than 2 percent.
Administration of the Moderna shots from the three lots was
suspended in Japan after 39 vials were found to contain foreign material. All
the vials came from a single lot, but shots from two other lots from the same
Rovi manufacturing line were suspended as a precaution.
Those three lots were the only ones affected by the
manufacturing issue, the statement said. Rovi has fully inspected its
manufacturing facility and implemented new procedures to avoid similar problems
in the future, it added.
Use of the Moderna vaccine from different batches also was
temporarily halted in three regions in Japan this week.
In some cases, foreign
substances were found in unused vials, while others appear to have been the
result of incorrectly inserted needles causing bits of the vials' rubber
stopper break off.
The contamination issue gained more attention after the
health ministry said on Saturday that two men, aged 38 and 30, died in August
within days of receiving their second Moderna doses. Each had received a dose
from one of the suspended lots.
The cause of death in the two cases is still being
investigated.
Moderna and Takeda said in the joint statement that there
was no evidence the fatalities were caused by the vaccine. "The
relationship is currently considered to be coincidental," the companies
said in the statement.
About 500,000 people have received shots from the three
suspended Moderna batches, Taro Kono, Japan's minister in charge of the
vaccination campaign, told reporters on Friday. Moderna said it cannot confirm
how many doses were distributed from the batches.
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