JAKARTA - The largest pharmaceutical company in Japan and Asia, Takeda Pharmaceutical Co. Ltd., said on Friday, human error caused metal contaminants to enter Moderna's COVID-19 vaccine, leading to withdrawal from use.
Takeda, which imports and distributes the vaccine in Japan, and Moderna said in a new report the Spanish manufacturer found contaminants in some bottles in July, but supplies of the same products were allowed to be shipped to Japan.
Japanese authorities in August suspended the use of three batches of Moderna injections, which had about 1.63 million doses after being notified of the contamination. Moderna is investigating in partnership with Takeda and Spanish manufacturer Rovi, which operates the plant where the contamination occurred.
"The problem stems from incorrect assembly and due to specific human error, to visually misjudge the required 1mm distance between the star wheel and the engine stopper, which places the top on the vaccine vial", the report said.
A total of five consecutive lots of the Moderna COVID-19 vaccine produced in Rovi between 27 June and 3 July were investigated. The first three were shipped to Japan and later recalled after the discovery of particles, later determined to be stainless steel, in 39 bottles.
However, the fourth lot failed to be inspected following the discovery of the particles on July 2, and the fifth lot was also detained by Rovi. Problems with Lots 4 and 5 were reported to Moderna, Takeda, and the Japanese Ministry of Health, but the first three lots were released for use as they had passed inspections and were not considered affected.
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"In fact, incorrect settings "caused the problem to persist across the entire five-batch series", the results of the investigation show.
"Better operating procedures and the use of new precision tools will help prevent the problem from recurring."
The company and the Japanese Ministry of Health said the stainless steel particles did not pose an additional health risk.
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