Takeda: Stainless steel COVID vaccine contamination due to human error
pharmafile | October 1, 2021 | News story | Medical Communications |
Takeda has said that “human error” led to metal contaminants being present in Moderna’s COVID-19 vaccine doses, which caused around 1.63 million doses to be suspended or recalled.
Moderna said in a new report that a Spanish manufacturer discovered contaminants in some vials in July, but supplies from the same production were still allowed to be shipped to Japan.
The contamination was discovered in Japan in August, and led to the suspension of three batches of Moderna shots containing 1.63 million doses.
An investigation was conducted by Moderna, alongside Takeda and Spanish manufacturer Rovi, which operates the plant where the contamination occurred.
The new report said the issue stemmed from “incorrect assembly and was due to human error specific to visually misjudging the required 1mm gap between the star-wheel and the stopper” of machinery that put the tops on vaccine vials.
A total of five sequential lots of the Moderna COVID-19 vaccine manufactured at Rovi between June 27 and July 3 were investigated by the companies. The first three were shipped to Japan and later recalled after the discovery of particles inside 39 vials, later determined to be stainless steel.
However, a fourth lot of vials failed inspection after the discovery of particles on 2 July, and a fifth lot was also held back by Rovi. The problems with the fourth and fifth lots were reported to Moderna, Takeda, and Japan’s health ministry, but the first three lots were released for use because they “had passed inspection and were not considered to be impacted.”
This led to around 500,000 people receiving shots from these three lots, but Moderna and the Japanese Health Ministry have both said that there were no additional health risks posed by the contaminants.
The report said that improved operating procedures and the use of a new precision tool will help prevent the issue from recurring.