The Ministry of Health, Labor and Welfare has announced the results of a company's investigation that metal pieces were mixed in the manufacturing process due to the problem that a foreign substance was found in a part of Moderna's new coronavirus vaccine and it is not used for about 1.6 million times nationwide. ..

All vaccines that are not used due to misplacement of parts will be collected after 2 days.

Since mid-last month, particulate foreign matter has been found in some of the unopened containers of Moderna vaccines at multiple vaccination sites nationwide.

The Ministry of Health, Labor and Welfare has suspended the use of a total of 1.62 million vaccines manufactured at the same process and delivered to 901 venues nationwide at the same time.

According to the Ministry of Health, Labor and Welfare, on the 1st, Moderna reported the results of an investigation that the foreign matter was a fragment of a stainless steel manufacturing part.

In the manufacturing process, parts came into contact with each other due to an installation error and were scraped off by friction and mixed.

Takeda Pharmaceutical Company Limited, which handles domestic distribution, has discussed with the Ministry of Health, Labor and Welfare and decided to collect all vaccines that are not being used from the 2nd.

On the other hand, since the amount of mixed metal pieces is very small and it is also used in artificial joints and pacemakers, it is unlikely that inoculation will have a significant impact on health.

In addition, foreign substances have been found in the vaccine containers of Moderna in Okinawa, Gunma, Tokyo, and Kanagawa prefectures, but it is highly possible that they were mixed in with the rubber pieces on the lid of the container during the manufacturing process and opening, so it is safe. The results of the survey have been published that there is no problem with.

Moderna "No significant impact on safety"

Moderna, an American pharmaceutical company, announced a comment jointly with Takeda Pharmaceutical Company Limited, which handles distribution in Japan.

Among them, "If a metal that is large enough to pass through an injection needle is injected into an intramuscular muscle, there is a possibility that the inoculated area may swell, but it is considered that there will be no significant impact on safety. We will strive to prevent recurrence, such as thorough visual inspection. "

In addition, last month, two men who were vaccinated with a vaccination that was not used because the possibility of contamination could not be ruled out although it was not the lot number where foreign matter was actually confirmed were killed. Is unknown and is believed to have happened accidentally at this time. The final decision is to wait for the official findings of the Ministry of Health, Labor and Welfare. "

The story so far

According to the Ministry of Health, Labor and Welfare, the first contact regarding foreign matter contamination was on the 20th of last month.

There was a report from the occupational inoculation venue that "foreign matter was mixed in the unopened vaccine container", and on the 23rd and 24th, the same contact was received from different occupational inoculation venues.

At this point, there was a possibility that rubber pieces were mixed in when opening the container at the inoculation site, so we decided to wait for the investigation by Takeda Pharmaceutical Company, which collected the container, to be completed before deciding what to do.

As a result, a total of 39 unopened containers in which foreign substances were found were found at eight inoculation sites nationwide. I received a report on the 25th of last month.

The Ministry of Health, Labor and Welfare discussed the response with Takeda Pharmaceutical Company Limited, and decided to suspend the use of a total of 1.63 million times manufactured in the same process at the same time because it cannot be denied that foreign matter may have been mixed in the manufacturing process. I explained it to the press before dawn on the following day, 26th.

* Target lot

▽ 3004667

▽ 3004734

▽ 30049556

New venue for occupational inoculation

According to the Ministry of Health, Labor and Welfare, there are 901 venues nationwide where three lots that have not been used have been delivered.

77 are large-scale inoculation venues set up by local governments and governments, and the Ministry of Health, Labor and Welfare has published 55 of them on its website that have already been confirmed to have been used for inoculation.

Initially, we did not announce the 824 venues for occupational inoculation, but we have announced 268 venues that have been confirmed and approved for use in the inoculation.