‘Human Error’ Caused Contaminated Moderna Vaccines In Japan
Moderna’s Japanese distributor, Takeda, said on Friday that “human error” caused metal particles that ‘react to magnets’ to contaminate batches of Covid-19 vaccines doses, leading to the suspension of 1.63 million vials.
At least two people died within days of receiving jabs from contaminated batches, however it is unclear if the contaminants caused the deaths, as they fit the profile of vaccine-induced myocarditis.
According to Reuters, Takeda – which imports and distributes the vaccine in Japan, said in a new report that the Spanish factory where the vaccine was manufactured had discovered contaminants in some vials which they say was caused by incorrect assembly due to a ‘visual misjudgement of the required 1mm gap’ between the stopper lids on the affected vials and the machinery which is used to insert them.
Five total lots were affected by the issue, three of which were shipped to Japan after passing inspection before they were recalled. The last two lots were withheld by the Spanish manufacturer, Rovi, after failing inspection on July 2.
A total of five, sequential lots of the Moderna COVID-19 vaccine manufactured at Rovi between June 27 and July 3 were investigated. The first three were shipped to Japan and later recalled after the discovery of particles, later determined to be stainless steel, inside 39 vials.
But a fourth lot failed inspection after the discovery of particles on July 2, and a fifth lot was also held back by Rovi. The problems with Lots 4 and 5 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.” –Reuters
The report said that the manufacturing process would use a new precision tool to prevent the issue from recurring.
Fri, 10/01/2021 – 20:00