The US' Moderna biotechnology firm and Japan's Takeda Pharmaceutical, which is in charge of the Moderna coronavirus vaccine's sales and distribution in Japan, announced on Friday that tiny metal chips found in several vials of the vaccine were the result of a human error
TOKYO (Pakistan Point News / Sputnik - 01st October, 2021) The US' Moderna biotechnology firm and Japan's Takeda Pharmaceutical, which is in charge of the Moderna coronavirus vaccine's sales and distribution in Japan, announced on Friday that tiny metal chips found in several vials of the vaccine were the result of a human error.
Earlier in the day, the two published a report recapping the results of the August probe launched after foreign substances were discovered in some vials of the vaccine distributed in Japan.
"The most probable cause of the particles identified in one of the recalled lots is related to friction between two pieces of metal installed in the stoppering module of the production line. This was the result of incorrect assembly and was due to human error specific to visually misjudging the required 1mm gap between the star-wheel and the stopper," the companies said in a joint statement, released by Moderna.
The rare presence of these particles posed no undue risk to patient safety and did not affect the benefit/risk profile of the product, the statement read.
After foreign substances were detected in different batches of the Moderna vaccine in August, Japan had to suspend the use of 1.63 million doses.
