Japan Suspends Use of 1.63 million Moderna Vaccines

CONTAMINATION OF METAL PARTICLES

Japan on Thursday suspended the use of 1.63 million doses here shipped to 863 vaccination centers nationwide, more than a week after the domestic distributor, Takeda Pharmaceutical, received reports of contaminants in some vials.

The contaminant found in a batch delivered to Japan is believed to be a metallic particle, Japanese public broadcaster NHK reported, citing health ministry sources.

"Particulates.  Based on past experience, these are likely to be glass chips or stopper detritis, but this should help get to the bottom of the graphene hypothesis.  I have confidence in the Japanese. "  Says, Dr Robert Malone

The European Union drugs regulator said it was investigating the incident at the Spanish plant run by Rovi, but did not find reasons to seek a temporary suspension of production after an initial assessment.

“COVID-19 vaccine production in Rovi is able to continue, following a preliminary risk assessment,” the European Medicines Agency told Reuters in a statement.

“An investigation into the root cause is ongoing. EMA will be able to provide more information as the investigation progresses,” it added.

Moderna has so far delivered to the EU nearly 75 million doses of its COVID-19 vaccine, EU public data show. The company has two contracts with the 27-nation bloc for up to 460 million shots.

Spanish pharma company Rovi, which bottles Moderna vaccines for markets outside of the United States, said the contamination could be due to a manufacturing issue on a production line. A spokesperson said the company could not say anything more while it was investigating.

Moderna put the lot in question and two adjacent ones on hold.

NHK, in a report published late on Thursday, cited health ministry sources as saying the contaminant was believed to be a particle that reacted to magnets and was therefore suspected to be a metal. Moderna has described it as “particulate matter” that did not pose a safety or efficacy issue.

A Japanese health ministry official said the composition of the contaminant has not been confirmed. In a statement, Takeda said it asked Moderna to investigate the issue and that it would work with the ministry to replace the affected supply.

News of the contaminant could prove a fresh setback for Japan’s inoculation drive as it struggles to persuade many - particularly young people - to get vaccinated.

See Reuters story

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