TOKYO, Oct. 1 (BNA) Japan’s Takeda Pharmaceutical Co., Ltd. said on Friday that “human error” caused metallic contaminants to enter Moderna’s COVID-19 vaccine doses, leading to their recall, Reuters reported.
Takeda, which imports and distributes the vaccine in Japan, and Moderna Inc. said in a new report that a Spanish factory detected contaminants in some vials in July, but that supplies of 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 they were notified of the contamination.
Moderna conducted an investigation in partnership with Takeda and the Spanish manufacturer Rovi, which operates the plant where the contamination occurred.
The new report said the problem arose from “improper assembly and was due to specific human error due to a visual miscalculation of the required 1 mm gap between the star wheel and the stopper” for the machines that place the tops on the vaccine vials.
A total of five consecutive batches of the Moderna COVID-19 vaccine manufactured in Rofi between June 27 and July 3 were screened. The first three were shipped to Japan and later recalled after particles, later identified as stainless steel, were discovered inside 39 flasks.
But a fourth batch failed the inspection after the particles were discovered on July 2, and Rovey also stopped a fifth batch. The problems with grades 4 and 5 were reported to Moderna, Takeda and Japan’s Ministry of Health, but the first three pieces were released for use because they “passed the examination and were not considered affected.”
In fact, the investigation showed that the incorrect setup “led the problem to persist throughout the five-pitch chain”.
The report said improving operating procedures and using a new precision tool would help prevent a recurrence of the problem.
The companies and Japan’s health ministry said the stainless steel particles posed no additional health risks.
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