• Bloomberg, KYODO, staff report

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Japan is investigating the deaths of two people who were given 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 swiftly conduct the investigations together with external experts, health minister Norihisa Tamura said during an NHK program on Sunday.

“(The) investigation is still ongoing, but we will quickly disclose what we find out,” Tamura said. “We would like the experts to examine under what circumstances the deaths occurred, and whether there were any causal relations” with the vaccine, he said.

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 at around the same time, the health ministry said.

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

The health ministry said Thursday that foreign substances had been confirmed in 39 unused vials at eight vaccination sites in five prefectures — Ibaraki, Saitama, Tokyo, Gifu and Aichi.

The same day, it halted the use of around 1.63 million doses, or three lots, which came from the same production line at a Spanish factory, as a precaution.

A health care worker administers a dose of Moderna Inc.'s COVID-19 vaccine at a mass vaccination site in Saitama on Aug. 23. | BLOOMBERG
A health care worker administers a dose of Moderna Inc.’s COVID-19 vaccine at a mass vaccination site in Saitama on Aug. 23. | BLOOMBERG

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.”

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

The prefecture said it found black particles and pink particles in vials before use at a mass vaccination center in Naha on Saturday. Moderna vaccinations at the same site were also suspended Sunday.

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.

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

The presence of the foreign substances had been known since Aug. 16, but Takeda only reported the problem to the ministry on Wednesday.

Taro Kono, the minister in charge of the vaccination rollout, said Friday that over 500,000 shots have already been administered from the potentially contaminated batches.

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

So far, more than 1,000 people in total have died in Japan after being administered a COVID-19 vaccine, but no causality has been established between the shots and the deaths, according to the health ministry.

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