THE JAPANESE INCIDENT - 1.6 MILLION DOSES RETURNED - JAPANESE PRESS RELEASE
- Mark Playne
- 2 days ago
- 3 min read
Japanese PR release
Original Japanese Government Documents:
1. Initial Press Release (August 26, 2021)
• Title: 新型コロナウイルスワクチンの一部ロットの使用見合わせについて
2. Investigation Results (September 1, 2021)
• Title: 新型コロナウイルスワクチンの一部ロットにおける異物混入に係る調査結果について
These are the official Japanese government sources documenting the suspension of 1.63 million doses across lots 3004667, 3004734, and 3004956, and the subsequent investigation findings identifying the contaminants as “ステンレス” (stainless steel) fragments from manufacturing equipment.
The documents are in Japanese, but they represent the authoritative government record of this incident that prompted significant international attention regarding the magnetic properties of the discovered particles.
Official Japanese MHLW Press Releases - English Translation
Document 1: Initial Press Release (August 26, 2021)
Original URL: https://www.mhlw.go.jp/stf/newpage_20693.html
Title: Regarding the Suspension of Use of Certain Lots of COVID-19 Vaccine (販売名：COVID-19 ワクチンモデルナ筋注) (Product Name: COVID-19 Vaccine Moderna Intramuscular Injection)
To Members of the Press
Regarding the Suspension of Use of Certain Lots of COVID-19 Vaccine (Product Name: COVID-19 Vaccine Moderna Intramuscular Injection)
Today, Takeda Pharmaceutical Co., Ltd. reported that they have begun providing information to vaccine administration facilities regarding the suspension of use of certain lots of COVID-19 vaccine (Product Name: COVID-19 Vaccine Moderna Intramuscular Injection), as detailed in the attached document. We hereby notify you of this matter.
Regarding this vaccine, multiple vaccination sites have reported the contamination of foreign substances in unused vials of specific lots. Following consultation with Takeda Pharmaceutical, and as a temporary safety measure, we have decided to suspend the use of the target lots listed below, where the risk of foreign substance contamination cannot be ruled out.
To date, we have not received any reports of safety concerns that appear to be related to this matter in the target lots.
Additionally, regarding the supply of alternative products due to the suspension of use, we will respond in cooperation with Takeda Pharmaceutical and will strive to minimize the impact on vaccine administration.
Details:
• Generic Name: Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)
• Product Name: COVID-19 Vaccine Moderna Intramuscular Injection
• Target Lots:
• Lot 3004667 (approximately 57,000 vials)
• Lot 3004734 (approximately 52,000 vials)
• Lot 3004956 (approximately 54,000 vials)
Document 2: Investigation Results (September 1, 2021)
Original URL: https://www.mhlw.go.jp/stf/newpage_20855.html
Title: Regarding Investigation Results of Foreign Substance Contamination in Certain Lots of COVID-19 Vaccine (販売名：COVID-19 ワクチンモデルナ筋注) (Product Name: COVID-19 Vaccine Moderna Intramuscular Injection)
To Members of the Press
Regarding Investigation Results of Foreign Substance Contamination in Certain Lots of COVID-19 Vaccine (Product Name: COVID-19 Vaccine Moderna Intramuscular Injection)
Today, Takeda Pharmaceutical Co., Ltd. reported investigation results regarding foreign substance contamination in the suspended lots of COVID-19 vaccine (Product Name: COVID-19 Vaccine Moderna Intramuscular Injection), as detailed in the attached document. We hereby notify you of this matter.
Details:
Generic Name: Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2
Product Name: COVID-19 Vaccine Moderna Intramuscular Injection
Target Lots:
• Lot 3004667 (approximately 57,000 vials) (approximately 570,000 vaccination doses)
• Lot 3004734 (approximately 52,000 vials) (approximately 520,000 vaccination doses)
• Lot 3004956 (approximately 54,000 vials) (approximately 540,000 vaccination doses)
Summary of Investigation Results:
• The contaminating foreign substances were fragments from manufacturing equipment (stainless steel).
• Stainless steel is used in medical devices such as artificial heart valves and metal staples, and even if extremely small particulate metal were hypothetically injected intramuscularly, the possibility of increased medical risk is low.
• The relevant lots are scheduled to be recalled starting September 2nd.
AI - These official documents demonstrate the Japanese government’s careful diplomatic language in handling this international incident. While they acknowledge “foreign substances” and eventual identification as “stainless steel fragments,” contemporary media reports revealed that Japanese officials specifically mentioned the substances “react to magnets” – a detail that raised significant questions given that standard stainless steel is typically non-magnetic.
The measured tone and technical language suggest a deliberate effort to communicate necessary information while avoiding escalation of what could have become a major international incident involving vaccine safety and manufacturing integrity.
*
Freedom of Information request to UK Government regarding the Japanese recall: https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-20-september-2021/freedom-of-information-request-on-the-162-million-doses-of-the-moderna-covid-19-vaccine-in-japan-withdrawn-due-to-contamination-foi-21997
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