What We Know About Japan's Moderna Vaccine Contamination

1 million more doses were suspended after black and pink substances were spotted in vaccine vials.
Chris Young
The photo credit line may appear like thissolarseven/iStock

Japan has temporarily suspended 1 million more doses of Moderna's COVID-19 vaccine after new reports of foreign substances found in vaccine vials and of two people dying shortly after vaccination from affected lots, a Reuters report reveals.

Reports of vaccine contamination from the Gunma prefecture near Tokyo and the southern prefecture of Okinawa lead to the suspension on Sunday of two more batches totaling 1 million doses. Last week, 1.63 million doses were suspended following similar contamination reports. 

Contamination hampers Japan's slow vaccine rollout

The substances spotted in the affected batches include a tiny black substance in a Moderna vaccine vial in Gunma and black and pink materials found in vials and syringes in Okinawa. Japan's health ministry claimed that the substances may have come from needles being incorrectly inserted, breaking off bits of the rubber stopper atop the vials. According to the latest reports, two people died shortly after receiving shots from a contaminated batch, though their deaths have not conclusively been linked to the contaminated vaccines. The government emphasizes that the dose suspensions were made as a precaution.

The latest batch suspension takes the total of suspended Moderna vaccine doses in Japan to 2.6 million after last week's suspension. It is a huge setback for the country's rollout, which has been criticized for its slow progress. Only 44 percent of Japan's population has so far been vaccinated.

"It is unlikely, in my opinion, that contamination of foreign substances led directly to sudden deaths," Takahiro Kinoshita, a physician and vice-chair of Cov-Navi, a vaccine information group, told Reuters. "If the contaminated substances were dangerous enough to cause death for some people, probably many more people would have suffered from some symptoms after the vaccination." However, Kinoshita did state that further investigation is required.

"Important to rely on a formal investigation"

Spanish pharmaceutical company Rovi bottles Moderna vaccines for markets outside of the United States. Rovi and Moderna stated that the contaminations may have been caused by a manufacturing issue in one of Rovi's production plants, though they cannot be sure until investigations are conducted.

"We are aware of unofficial reports that have provided initial indication of the type of particle matter in the vials," Moderna and its Japanese distributor Takeda said in a joint statement. "These reports are inconclusive and it is important to rely on a formal investigation before determining the precise nature of the particle... The vials have been sent to a qualified lab for analysis and initial findings will be available early next week."

Japan is in the midst of its worst wave of COVID-19 to date as new daily infections exceeded 25,000 for the first time in the country this month, largely due to the more contagious Delta variant. Experts are urging the country to continue its vaccination drive amid precautions over the contaminations. They point out that more than 500,000 thousand citizens have received doses from one of the contaminated batches and no other complications have been reported so far.


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