TOKYO, Oct 1 (Businesshala) – Japan’s Takeda Pharmaceutical Co Ltd said on Friday that “human error” caused metal contaminants to be found in Moderna Inc’s COVID-19 vaccine doses, prompting a withdrawal.
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 allowed supplies from the same production to be shipped to Japan.
Japanese authorities in August suspended the use of three batches of Moderna shots, containing 1.63 million doses, after contamination was reported. Moderna conducted an investigation in partnership with Takeda and Spanish manufacturer Rovi, which operates the plant where the contamination occurred.
The new report stated that the problem “stemmed from incorrect assembly and that it was due to human error to incorrectly identify the required 1 mm gap between the uniquely star-wheel and the stopper” that was placed at the top of the vaccine vials. holds.
A total of five, successive lots of the Moderna COVID-19 Vaccine manufactured at Rovi were screened between June 27 and July 3. The first three were shipped to Japan and later recalled after particles were discovered inside 39 vials, which were later determined to be stainless steel.
But the inspection of the fourth lot failed after the particles were discovered on July 2, and the fifth lot was also withdrawn by Rovi.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 because they “passed the inspection and were not considered affected. “
In fact due to incorrect set-up “the problem persisted throughout the series of five batches,” the investigation revealed.
Better operating procedures and the use of a new precision instrument will help prevent the issue from recurring, the report said.
The companies and Japan’s health ministry have stated that the stainless steel particles did not pose any additional health risks. (Reporting by Rocky Swift in Tokyo; Editing by Kim Coghill)