TOKYO — A third person has reportedly died in Japan after receiving a COVID-19 vaccine from a batch of doses that are being recalled in that country because they’re contaminated with tiny stainless-steel particles.
According to those news outlets, the man’s only known health issue was an allergy to buckwheat and like the previous two deaths, Japan’s health ministry has yet to establish if the latest fatality was linked to the vaccine.
Moderna Inc. and its Japanese partner, Takeda Pharmaceutical Co., announced in late August that it was suspending the use of certain lots of the vaccine: 3004667, 3004734, and 3004956. They enacted the suspension of the 1.63 million doses after receiving reports of foreign matter in unpunctured vials.
On Aug. 28, Takeda said it was notified of the deaths of two people who received its Moderna vaccine in Japan.
In a Sept. 1 update from Takeda, the company said an investigation found that the most probable cause of the foreign matter in the affected vials was “related to friction between two pieces of metal” in a production line.
“The two pieces are the star-wheel and the stoppers feeding device piece which feeds stoppers into the star-wheel. It is believed that this condition occurred during the assembling of the line prior to production of batch 3004667 and was a result of improper alignment during a line changeover before starting this batch,” wrote Takeda.
The company says the manufacturing issue only impacted the lots that were included in the suspension.
Despite the deaths in Japan, Takeda said, “The rare presence of stainless-steel particles in the Moderna COVID-19 vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product.”
At this time, Takeda says there is no evidence that the deaths of the people who received the affected vaccines were “in any way related” the administration of the vaccine.
“The relationship is currently considered to be coincidental. It is important to conclude a formal investigation to confirm this,” said the company.
As of last week, Takeda says more than 200 million doses of Moderna’s COVID-19 vaccine have been administered to more than 110 million individuals in 45 countries, representing a critical component of the global fight against COVID-19.
No problems related to this issue have been reported in the U.S.