Foreign Substance in Moderna Discontinued in Japan Identified as Stainless Steel Particles

Foreign Substances Mixed in Moderna Due to Parts Falling Off Manufacturing Equipment
Recall Starting from the 2nd

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kwon Jae-hee] Foreign substances found in Moderna COVID-19 vaccines used in Japan have been identified as stainless steel particles.

According to Kyodo News on the 2nd, Takeda Pharmaceutical Company, which is responsible for distributing Moderna vaccines in Japan, announced the results of an investigation stating that the foreign substances found in some Moderna vaccines were fragments that came off stainless steel parts of manufacturing equipment.

Takeda Pharmaceutical plans to recall vaccines from three lot numbers (manufacturing process identification codes) where metallic foreign substances were confirmed, starting from the 2nd.

Previously, metallic-looking foreign substances were found in 39 unused vials of Moderna vaccines with the same lot number (3004667) at eight vaccination sites operated by five metropolitan governments including Tokyo. Takeda Pharmaceutical has been investigating the cause of the contamination together with Moderna and the Spanish pharmaceutical company Laboratorios Farmac?uticos Rovi, which is responsible for manufacturing.

The Japanese Ministry of Health, Labour and Welfare ordered the suspension of use not only for the lot number where the foreign substances were first detected but also for two other lot numbers (3004734, 3004956) of vaccines manufactured through the same process at the same Spanish factory by Moderna, totaling about 1.63 million doses.

In this situation, there have been cases where two men in their 30s who received vaccines from the suspended lot number (3004734) died.

The stainless steel containing the fragment particles in the problematic vaccines is known to be a material used in artificial heart valves and other medical devices.

Takeda Pharmaceutical explained that the fragment particles likely came off due to friction between two stainless steel parts installed on the production line that attaches rubber stoppers to the vaccine vials, and that the parts may have been improperly installed during maintenance of the production line.

Takeda Pharmaceutical also stated that if fragment particles are injected into the body via intramuscular injection like the Moderna vaccine, local reactions may occur, but the likelihood of increased medical risk is low.

Regarding the two deaths after receiving the suspended vaccines, they said, "A causal relationship with the vaccination has not been confirmed," and "At this point, it appears to be an incidental occurrence."

The Ministry of Health, Labour and Welfare plans to hold an expert meeting soon to evaluate the causal relationship with the deaths, referring to Takeda’s investigation results.

Meanwhile, foreign substances have also been found in Moderna vaccines at vaccination centers in Okinawa, Kanagawa, Gunma Prefecture, and other locations in Japan.

Investigations concluded that these foreign substances appeared to be fragments of rubber stoppers from the containers.

This content was produced with the assistance of AI translation services.