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.

A report has been received regarding the investigation results of foreign matter contamination in the batch of the COVID-19 Vaccine Moderna Intramuscular Injection, which was withheld from use.

According to investigation results, the foreign substance mixed into the vials is highly likely to be rubber stopper-like debris that has been rarely found in multiple lots of the product. Other vials from the same lot are considered to have no issues with efficacy or safety, and vaccination with the vaccine from this lot is not deemed necessary to be withheld.

According to investigation results, the foreign substance mixed into the vials is highly likely to be a rubber stopper-like foreign object that has been rarely found in multiple lots of the product. Other vials from the same lot are considered to have no issues with efficacy or safety, and it is believed that vaccination with the vaccine from this lot does not need to be withheld.

According to the investigation, vials with foreign objects were confirmed not to have had foreign objects before puncture. It is highly likely that the foreign objects were introduced during puncture, such as through coring, and therefore there is no issue with the quality of the vaccine from this lot.

A report has been received that certain lots of the COVID-19 Vaccine Moderna Intramuscular Injection (brand name: COVID-19 ワクチンモデルナ筋注) are being withheld from use. Multiple vaccination facilities reported foreign matter contamination in unused vaccine from specific lots. As a safety measure, in consultation with Takeda Pharmaceutical Company, the use of the following lots, where the risk of foreign matter contamination cannot be ruled out, has been suspended.

Regarding certain lots of the COVID-19 Vaccine Moderna Intramuscular Injection (brand name: COVID-19 ワクチンモデルナ筋注), reports from multiple vaccination facilities indicated the presence of foreign substances in unused vaccines. After discussions with Takeda Pharmaceutical Company, as a safety measure, the use of the following lots, where the risk of foreign substance contamination cannot be ruled out, has been suspended.

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 Ministry of Health, Labour and Welfare has revised the 'Precautions for Use' section of the package insert for the antiepileptic and bipolar disorder medication 'Lamictal Tablets' (attached document 1), based on reports of severe skin disorders leading to death. Additionally, it instructed manufacturers and marketers to promptly alert healthcare professionals through a 'Safety Information (Blue Letter)' (attached document 2).

The Ministry of Health, Labour and Welfare has revised the 'Precautions for Use' section of the package insert for the hepatitis C treatment drug 'Sovriad Capsules 100mg' (Attachment 1) based on reports of deaths associated with hyperbilirubinemia. Additionally, they have instructed the manufacturer to promptly issue a safety alert (Blue Letter) (Attachment 2) to healthcare professionals to raise awareness.