Japan is to halt the use of 1.63 million doses of Moderna Inc’s COVID-19 vaccine after reports of contamination in several vials, drugmaker Takeda Pharmaceutical Co and the Japanese Ministry of Health said yesterday.
Takeda, which is in charge of sales and distribution of the Moderna vaccine in Japan, said that it had “received reports from several vaccination centers that foreign substances have been found inside unopened vials.”
“Upon consultation with the health ministry, we have decided to suspend the use of the vaccine” from three batches from yesterday, it added.
Photo: Reuters
The firm said that it had informed Moderna and “requested an urgent investigation.”
In a statement, Moderna said that the reported contaminations involved “one product lot distributed in Japan.”
“Moderna believes the manufacturing issue was generated in one of the lines used at its contract manufacturing site in Spain,” it added, saying that so far “no safety or efficacy issues have been identified.”
“Out of an abundance of caution, Moderna has put this lot and two adjacent lots on hold,” it said, without specifying the nature of the contamination.
“We have not received reports of health problems stemming from the foreign object,” Japanese Chief Cabinet Secretary Katsunobu Kato told reporters.
“But we are asking people to consult their physicians if they experience any abnormality,” he said.
Contaminants were seen in 39 unopened vials at eight vaccination locations in central Japan, including Tokyo, Japan Broadcasting Corp reported.
The Japanese Ministry of Defense said that doses from a suspended batch had been administered between Aug. 6 and Friday last week at its mass vaccination center in Osaka.
However, staff visually checked vials for contaminants before injecting the formula, the ministry said, adding that its Tokyo vaccination center was not affected.
Kato said there had been no “concrete reports” that doses confirmed to contain contaminants had been administered.
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