Home >Companies >News >Moderna says covid-19 vaccine contaminant in Japan was stainless steel, sees no safety issue

The foreign substance detected in some vials of Moderna Inc.’s Covid-19 vaccine in Japan was stainless steel and it isn’t believed to affect the vaccine’s safety or efficacy, Moderna and its Japanese partner said.

Moderna and Takeda Pharmaceutical Co. reported the initial results of their investigation after Japan last week recalled three lots of the Moderna vaccine containing a total of 1.63 million doses, citing unspecified contamination.

The companies said the stainless steel got into the vaccine vials because metal parts were improperly installed on a production line at Moderna’s contract facility in Spain. They said the material is routinely used in heart valves and joint replacements and “doesn’t pose an undue risk to patient safety." It also wouldn’t affect vaccine efficacy, they said.

The issue affected only the three lots recalled by Japan, the companies said. Japanese officials said contamination was found in one of the three lots and the remaining two were pulled as a precaution because they were manufactured at the same time on the same production line.

The government said 500,000 doses from those three lots were administered. Two men in their 30s recently died days after receiving a second dose from one of the two lots which had no reported contamination but were pulled as a precaution.

Moderna and Takeda said there was no evidence that the vaccine was connected to the deaths. They said the relationship is considered coincidental but an investigation continues.

Most of Japan’s vaccine supply has come from Pfizer Inc., but Moderna’s vaccine has been used at large-scale centers operated by the government and large employers. Currently 46% of the nation’s 126 million people are fully vaccinated.

After last week’s recall, additional reports of contamination in the Moderna vaccine emerged. The government said the cause was rubber bits from the vial’s rubber stopper and it kept the lots in use, saying the material was unlikely to affect safety even if injected into the body.

This story has been published from a wire agency feed without modifications to the text





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