Moderna Says No Evidence Yet Between Vaccine Particles and Japan Deaths
(Bloomberg) -- Moderna Inc. and its Japanese partner Takeda Pharmaceutical Co. said there is currently no evidence linking the deaths of two men in Japan to stainless steel particles found in vials of the Moderna vaccine.
The deaths are currently considered coincidental, pending the end of a formal investigation, the drug makers said in a joint statement Wednesday.
Takeda, which is the local distributor of Moderna’s shot, said an investigation by Moderna and its manufacturing partner Rovi SA showed the debris was stainless steel. The particles likely got into the vials due to an incorrect set up on the manufacturing line that caused two pieces of metal to rub up against each other.
Metallic particles in the size seen in the Moderna vials may result in a local reaction if injected into muscle, but shouldn’t cause other adverse effects, Takeda said.
Rovi said no other lots were affected by the manufacturing issue.
Takeda said it will recall the three lots of vaccine that were halted.
The two men received their second shots from a lot that didn’t have any foreign particles reported, but was halted because the batch was produced at the same facility around a similar time, the Japanese health ministry said Saturday.
Japan has a deal for 100 million doses of Moderna’s vaccine -- half to be delivered this year and half in 2022. About 130.9 million vaccine doses have been administered in Japan, and about 46% of its population is fully inoculated, government data show.
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