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Moderna vaccine programme hit by contamination incidents in Japan

The Moderna coronavirus vaccine programme in Japan has been hit by a series of contamination incidents, prompting it to recall 1.63m doses found to contain metal fragments as the country battles its fifth and worst wave of infections.

Around 500,000 people have received jabs from the three suspended Moderna batches, according to Taro Kono, Japan’s minister in charge of the vaccination campaign.

The disruption to Moderna supplies comes as Japan reports new daily infections exceeding 25,000 in August for the first time amid a slow vaccine rollout. Only 44% of Japan’s population has been fully vaccinated.

Moderna conducted its investigation in partnership with Takeda, the distributor of the Moderna vaccine in Japan and Spanish manufacturer Rovi, which operates the plant where the contamination occurred. Moderna said the stainless steel contamination probably occurred during production.

“Stainless steel is routinely used in heart valves, joint replacements and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk,” Takeda and Moderna said in a joint statement.

Administration of Moderna shots has been halted in Japan after 39 vials were found to contain foreign material. All the vials came from a single lot, but shots from two other lots from the same Rovi manufacturing line were suspended as a precaution.

Those three lots were the only ones affected by the manufacturing issue and there have been other cases of potential contamination. On 28 August, use of the Moderna vaccine was temporarily suspended on the island of Okinawa after black and pink substances were found in different vials from a batch separate to the previously recalled ones.

Health minister Norihisa Tamura said that the substances were likely pieces of rubber stoppers on the vials that had entered the liquid due to incorrectly inserted needles.

W Denis provides global coverage for the costs associated with the Recall of Products, including withdrawal expenses, investigation costs, business interruption as well as PR crisis management fees to mitigate the reputational damage that can otherwise be incurred through ineffective communications.

 To discuss this further with an expert at W Denis, please contact Daniel Moss at daniel.moss@wdenis.co.uk or on 0044 (0)113 2439812

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