Japan has put 1.6 million doses of the Moderna vaccine on hold after “foreign materials” were discovered in approximately 565,000 vials.

The contamination stemmed from batches of Moderna’s COVID-19 vaccine produced by contract development manufacturing organization (CDMO) Rovi – also known as Laboratorios Farmacéuticos Rovi. The firms conducted an investigation after particulate matter was identified in vials of the vaccine distributed in Japan last week.

“According to the root cause analysis report, conducted by Rovi, the most probable cause of the particulates identified in lot 3004667 is related to friction between two pieces of metal installed in the stoppering module of the production line due to an incorrect set-up,” Moderna and Takeda said in a joint statement.

“The two pieces are the star-wheel and the stoppers feeding device piece which feeds stoppers into the star-wheel. It is believed that this condition occurred during the
assembling of the line prior to production of batch 3004667 and was a result of improper alignment during a line changeover before starting this batch. Based on the analysis conducted by Rovi, the manufacturing issue only impacted the lots that were included in the suspension.”

Image: Stock Photo Secrets

Rovi joined the list of firms supporting the production of Moderna’s  vaccine mRNA-1273 in July 2020 by providing fill-finish and packaging services for the company.

Shortly after Japan suspended the use of 1.63 million doses of Moderna’s vaccine, two prefectures temporarily halted their rollouts of the shot.

According to Reuters, the decision to provisionally stop the vaccine rollout came after reports of vaccine contamination from the Gunma region located near Tokyo and Okinawa situated in the south.

The publication also added that a local official in Gunma said black substance had been found in a Moderna vaccine vial, while in Okinawa black substances were identified in syringes and a vial, and pink material spotted in a separate syringe.

Japanese health minister Norihisa Tamura said it is highly likely that the foreign matter seen in Moderna’s vaccines in Okinawa may have been caused by needles being incorrectly inserted into vials, Reuters reported.

Health ministry officials and Takeda Pharmaceuticals, which distributes the vaccine in Japan said there is no need for a nationwide suspension as no efficacy or safety issues have been established with the affected batches.

Two deaths

The news of contaminated vaccines comes after reports two men in their 30s died in Japan within three days of receiving their second Moderna jab, which were among the doses later suspended due to risk of contamination.

The two individuals are said to not have any underlying health conditions. However, there is no evidence that the deaths were caused by the contamination, or even the vaccine itself.

“As reported publicly by the laboratory owning the vaccine, Moderna, and the company in charge of distributing the vaccine in Japan, Takeda, unfortunately, the death of two individuals who had received the Moderna COVID-19 vaccine have been reported,” Encina said in a statement.

“There is no evidence up to date that these deaths are caused by the Moderna COVID-19 vaccine. In any event, there is a formal investigation underway to determine whether there is any connection.”

A spokeswoman for Rovi told us it could not provide any further details at this moment in time as it “must wait until the investigation is finalized and the relevant conclusions are published.”