Japan recalled 1.63 million doses of Moderna vaccines after several batches imported from Spain were found contaminated with metal fragments.
Foreign black substances were found in vials of Moderna vaccines in Kanagwa, Gunma, and Okinawa.
More than 500,000 jabs from the contaminated batches have been administered, but no related injuries have been reported so far.
Moderna Inc. reassured in a joint statement with Japanese distributor Takeda Pharmaceutical that the anomaly would cause nothing more than a localized reaction.
“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,” Moderna said.
Moderna and Takeda will investigate how the steel particles have entered the vaccine vials along with Rovi Pharma — the Spanish firm that produced and imported Moderna batches for Japan.
The companies suggested that the contaminants may have come from technical failures in the production line.
The withdrawal of doses came as Japan battles its worst wave of COVID-19 infections, topping over 20,000 cases daily.
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