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This Article is From Aug 29, 2021

Japan Probing Deaths of Two People Who Had Moderna Shots

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Japan is investigating the deaths of two people who were administered Moderna Inc.'s Covid-19 shots from vaccine batches which have since been suspended.

While the relationship between the deaths and the shots is currently unclear, the health ministry will conduct the investigations together with external experts, and continue to assess the safety of the vaccine, according to a statement on Saturday.

Doses from three lots have been halted following reports that foreign particles were found in one of the batches. The two people received their second shots from a lot that didn't have any foreign particles reported, but it was suspended because the batch was produced at the same facility around a similar time, the health ministry said.

The two deaths, both men in their 30s, were confirmed three days after they received their second Moderna vaccines this month, the health ministry said. Neither men had a history of allergies or other underlying conditions. 

Japan Halts Use of 1.6 Million Moderna Shots Tied to Debris

Takeda Pharmaceutical Co Ltd., the local distributor of the Moderna shot, and the vaccine manufacturer said it's important that the relationship between the deaths and the shots is officially investigated. No link has been detected so far, they said in a joint statement on Saturday.

“The investigation is being conducted with the greatest sense of urgency, transparency and integrity and is of the highest priority,” the companies said. “Takeda and Moderna will keep the public informed as we learn more.”

Japan's heath minister Norihisa Tamura said on national broadcaster NHK Sunday that the investigation into the cause of the deaths is still ongoing. 

Takeda has requested that Moderna and the company's European contract manufacturing organization “urgently” conduct a thorough investigation to determine the nature of the foreign substance, according to the joint statement. 

“We are aware of unofficial reports that have provided initial indication of the type of particle matter in the vials,” they said. “These reports are inconclusive and it is important to rely on a formal investigation before determining the precise nature of the particle. Moderna is in the process of conducting that investigation and the vials have been sent to a qualified lab for analysis and initial findings will be available early next week.”

Separately, Okinawa prefecture in southern Japan suspended some Moderna vaccinations Saturday evening after observing foreign-looking particles in doses that did not come from the three halted batches, said Atsushi Mizuta, an official there overseeing the vaccination program. The prefecture said it's discussing next steps with the health ministry.

Earlier in the week, Takeda said there have been no safety concerns tied to the halted vials, and vaccinations using Moderna's other shots in Japan will proceed as usual.

About 124.5 million vaccine doses have been administered in Japan, and about 43.5% of its population is fully inoculated, government data show.

©2021 Bloomberg L.P.

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