武田薬品工業株式会社

A special approval was granted under Article 14-3 of the Pharmaceuticals and Medical Devices Act for a partial change to the manufacturing and marketing approval of the COVID-19 vaccine.

The foreign matter mixed in was fragments of manufacturing equipment (stainless steel).

It is believed that foreign matter contamination likely occurred during the manufacturing process. There have been reports, both domestically and internationally, of rare cases where rubber stopper-like fragments have been suspected to have mixed into vials, although the probability is very low. Even in such cases, it has been reported that the efficacy and safety of other vials from the same lot are unaffected. The foreign substance reported this time is considered to be a similar case.

It is considered highly likely that foreign matter was introduced during the manufacturing process. The foreign matter is most likely fragments resembling rubber stoppers, and foreign objects were found inside the vials before puncture.

During the manufacturing process, although the probability is very low, there is a rare possibility that fragments resembling rubber stoppers could be mixed into the vials. Even if rubber stopper fragments are mixed in, it has been reported that there are no issues with the efficacy or safety of other vials from the same lot.

Multiple vaccination facilities reported foreign matter contamination in unused vaccine.

Foreign substance contamination was reported in unused vaccines from multiple vaccination facilities.

A special approval for the novel coronavirus vaccine was granted under the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices.

The manufacturer and marketer repeatedly distributed 'Requests for Proper Use' to healthcare professionals and others, providing warnings and cautions.

There have been reports of cases where administration of this drug caused a significant increase in blood bilirubin levels, leading to liver and kidney dysfunction, and resulting in death. Therefore, the following precautions should be observed: 1. Regularly measure blood bilirubin levels during treatment. 2. Discontinue the drug and provide appropriate treatment if abnormal persistent elevation of blood bilirubin is observed. 3. Even after discontinuation, blood bilirubin levels may remain elevated; patients should be monitored carefully. 4. Instruct patients to seek medical attention immediately if they develop jaundice of the eyes or skin, dark urine, or general fatigue after administration.