Gunma Prefecture Vaccine foreign body at the inoculation site Rubber stopper fragment of container or Ministry of Health, Labor and Welfare

Regarding foreign substances in Moderna's new coronavirus vaccine found at the inoculation site in Gunma Prefecture, the Ministry of Health, Labor and Welfare said that there is a high possibility that the rubber stoppers of the containers that are mixed in during the manufacturing process are broken, and there is no problem with safety. We have announced the results of the survey.

On the 29th, Gunma Prefecture revealed that a blackish foreign substance was found in a container of Moderna vaccine before opening at a large-scale inoculation center in Ota City.

It is less than 0.5 mm in size, unlike the three lot numbers that the country has forgotten to use.

According to the Ministry of Health, Labor and Welfare, Takeda Pharmaceutical Company Limited, which handles domestic distribution, reported that there is a high possibility of fragments of the rubber lid of the container as a result of the investigation.

It seems that it was mixed when the lid was attached in the manufacturing process, and the Ministry of Health, Labor and Welfare said, "In this case, which is reported very rarely at home and abroad, there is no problem with safety and effectiveness, and it is not necessary to refrain from inoculation." is.

According to the Ministry of Health, Labor and Welfare, there have been similar reports in Japan about 1 in 100,000 vaccines of Moderna, so even if it is used for inoculation, it will clog blood vessels due to intramuscular injection. That is not the case.

In Okinawa Prefecture, on the 28th, a foreign substance was found in the container after opening at a large-scale inoculation center in Naha City, and the Ministry of Health, Labor and Welfare said that when the injection needle was stabbed in the lid, a part of the rubber stopper was scraped off and mixed. Explains that it is likely.

Four similar cases have been reported at the inoculation site in Tokyo, and the Ministry of Health, Labor and Welfare is calling on local governments to pierce the injection needle perpendicular to the lid.

On the other hand, it is expected that the results of the survey will be released earlier this week for vaccines with three lot numbers that are not being used because it is possible that particulate foreign matter that seems to be made of metal was mixed in during the manufacturing process. ..