Foreign Substance Reported in Moderna Vaccine in Okinawa, Japan Confirmed as Cap Debris

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kwon Jae-hee] Amid reports of foreign substances found in Moderna COVID-19 vaccines in Japan, an investigation revealed that some of these foreign substances were fragments of rubber stoppers from the vials caused by incorrect needle insertion into the syringe.

According to the Mainichi Shimbun on the 30th, the Ministry of Health, Labour and Welfare announced the day before that the foreign substances related to the Moderna vaccine reported in Okinawa were fragments that came off the rubber stopper of the vial during the process of drawing the vaccine into the syringe.

Earlier, foreign substances were consecutively found in Moderna vaccines scheduled for use on the 28th at a mass vaccination center in Naha City, Okinawa Prefecture.

The foreign substances were black and were discovered during a visual inspection before use in one small vial containing the vaccine and two syringes filled with the vaccine.

Accordingly, Okinawa Prefecture authorities suspended vaccinations using the vaccine lot number (manufacturing process identification code, 3005293), and during further checks, a translucent pink foreign substance was also found in another syringe filled with the vaccine.

Among these, the black foreign substance was identified as a piece of the vial’s rubber stopper.

This was confirmed through an investigation by Takeda Pharmaceutical Company, which is responsible for supplying the Moderna vaccine in Japan.

The pink foreign substance is suspected to have originally been mixed inside the syringe, and the syringe manufacturer is currently investigating its composition and cause.

The Ministry of Health, Labour and Welfare explained that since the rubber stopper is made of sterile material and fragments injected into the muscle pose no risk of blocking blood vessels, there is no problem with the vaccine quality itself.

The ministry also added that when drawing the vaccine from the vial into the syringe, inserting the needle at an angle can cause a phenomenon called "coring," where pieces of the rubber stopper come off, so care must be taken to insert the needle vertically.

[Image source=AP Yonhap News]

Meanwhile, in Gunma Prefecture, foreign substances were found in a Moderna vaccine dose (for 10 people) scheduled for use on the 29th.

Although Gunma Prefecture authorities did not disclose the lot number (manufacturing process identification code) of the vaccine, the Mainichi Shimbun reported that it was a different vaccine from the lot number for which the Ministry of Health had requested suspension due to foreign substances found in other regions.

Earlier, on the 26th, the Ministry of Health, Labour and Welfare requested suspension of use after foreign substances, suspected to be metal, were found in 39 unused vials of Moderna vaccines imported from Spain and supplied to local governments, all sharing the same lot number.

The locations where these foreign substance-containing vaccines were found include eight vaccination sites operated by five metropolitan governments including Tokyo.

The Ministry of Health, Labour and Welfare suspended the use of three lot numbers (3004667, 3004734, 3004956) of vaccines, totaling approximately 1.63 million doses, which were manufactured at the same Spanish factory by Moderna under the same process, in addition to the lot number where foreign substances were found.

Takeda Pharmaceutical Company and Moderna are currently conducting investigations to identify the cause of these foreign substances.

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