Suspended vaccines and foreign substances in the vials | 日本語

By August 26th, foreing substances in a Moderna COVID-19 vaccine vials were reported, and UTokyo vaccine team has taken the following measures. So far, we check every vial before use from the start of the program, and we found no abnormal vials.

新型コロナワクチンの一部ロットの使用見合わせについて (About the partial suspension of COVID-19 vaccine.) (Japanese language only)|| Ministry of Health, Labour and Welfare, Japan.
* Check your vaccination record issued at the venue. You'll see the lot number on the sheet.
Inquiry can be done through email. The address is on the reservation web site or is provided by the organizer of each vaccinee group.

(descending order) event action of UTokyo vaccine team
November 1   UTokyo vaccination program ended on October 29.
   

Vaccines that have been notified of suspend of use by the Ministry of Health, Labor and Welfare or manufacturers, or vaccines that are expected to be suspended due to media reports, will be suspended at the the UTokyo vaccination program as soon as information becomes available.

We continue to collect information on foreign substances or other problems. We will continue to put the safety and health first of all.

    The vial (vaccine container) before opening is visually checked for damage, foreign substances, etc. When filling the vaccine we carefully check again the vials and syringes for foreign substances or any other problems before making preparations.
September 26  

There was a report on August 26 that some vaccines were contaminated with foreign substances. The vaccine of the same lot number was also used at the University of Tokyo's vaccination site, but no reports of special side reactions that seemed to be related to this occurred during the following month from those who received the vaccine at the University of Tokyo.

As previously announced, no foreign substance was found in the Lot No. 3004667 vaccine used at the the University of Tokyo during the pre-use inspection.

September 7

新型コロナワクチン(異物混入の報告はないものの回収対象としたロット)接種後の死亡事例(3例目)の報告について」("About the report of 3rd death case after inoculation of the COVID-19 vaccine (lots that have not been reported to be contaminated with foreign substances but have not been used)" Japanese language only) | Ministry of Health, Labour and Welfare.

Three deaths after the COVID-19 vaccine which was suspended for use due to stainless metal contamination are reported. Lot 3004734 was one of suspended lots, but no contamination was reported from the lot.

The lot used in the death cases was different from that used at UTokyo.

September 1

Announcement by the ministry of health, labour and welfare of Japan: "Survey results on foreign matter contamination in some lots of the new coronavirus vaccine" (in Japanese.)

Summary:

  • foreign substances in the vial was stainless steel debris from manufacturing devices.
  • stainless steel is often used as a material of implantable medical devices such as an artificial heart valve or metal staples.
  • very small amount of stainless steel would not raise the medical risk even if it were injected into the muscle.

The suspended vaccines that are stored at UTokyo will be collected by the manufacturer and will not be used for immunization at UTokyo.

We will continue the vaccination program while paying close attention to the safety of the entire vaccination process.

You may be able to find related reports through the internet using the search terms like "Moderna recall COVID-19 Japan stainless steel" with your choice of a search engine.

September 1   University of Tokyo officially made a comment on the foreign substances in the vaccine. English version is not available at the moment.
August 31

新型コロナワクチンの一部ロットの使用見合わせについて|Ministry of Health, Labour and Welfare. (Update)

Takeda Pharmaceutical Company Limited. "Announcement about COVID-19 vaccine from the company." (Japanese language only.)

 
August 30 群馬県における新型コロナウイルスワクチンの一部ロットの接種中止について ("About the suspension of vaccination in Gunma prefecture due to foreign substaces found in an unopened vaccine vial." Japanese language only) |Ministry of Health, Labour and Welfare. UTokyo vaccination team continues its effort to provide safer vaccination through checking processes of each step and information gathering.
August 28

新型コロナワクチン(異物混入の報告はないものの使用を見合わせたロット)接種後の死亡事例の報告について ("About the report of death cases after inoculation of the COVID-19 vaccine (lots that have not been reported to be contaminated with foreign substances but have not been used)" Japanese language only) | Ministry of Health, Labour and Welfare.

Partial quote below (underlined: supplemented by us):
Lot 3004667 (about 57,000 vials) Foreign substances found (Used at UTokyo. No report at UTokyo through before-use visual check.)
Lot 3004734 (about 52,000 vials) Foreign substances not found. Two death report.
Lot 3004956 (about 54,000 vials) Foreign substances not found.

Moderna and Takeda’s Response to the Incidents Announced by the Japanese Ministry of Health, Labour and Welfare (MHLW) associated with the Announced Suspension of Use of Specific Lots of Moderna’s COVID-19 Vaccine in Japan | Takeda Pharmaceutical Company Limited.

There was a report of deaths from the ministry of health after the administration of the vaccine that was suspended for use due to foreign substances in some vials. The lot used in the death cases was different from that used at UTokyo. We have received concerns from UTokyo members who received the vaccine in question, but there are no reports so far of serious adverse reactions such as anaphylaxis or hospital admission that are suspected to be related to the vaccine.
2PM, August 27. Additional vaccines were provided. The reservation resumed.
August 27 ~   Those who already have a reservation for the vaccination can receive a shot. Please come to the site as reserved.
August 26.  

All reserved vaccinations were safely completed without vaccines of the lot in question.

The announcement about the problem is posted inside the vaccination venue.

 

The manufacturer of the vaccine informed us of the report of foreign substances found in some vaccine vials.

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 (販売名:COVID-19 ワクチンモデルナ筋注) ( Japanese language only) | Ministry of Health, Labour and Welfare.

Notice of Suspension of Use of Specific Lots of Moderna’s COVID-19 Vaccine in Japan (COVID-19 Vaccine Moderna Intramuscular Injection) | Takeda Pharmaceutical Company Limited.

The reservation system is temporarily closed -> Resumed on 27th. We are checking the number of existing reservations and the vaccine stock. Because some vaccines were withdrawn from the stock, we do not have enough usable vaccines in hand. Some readjustment needs to be done to reopen the reservation. We are expecting additional vaccines to compensate the withdrawal.

Reservations until September 3rd are valid, and we are continuing the vaccination program. We will reopen the reservation when the outlook becomes clearer.

Morning, August 26.

News report about foreign substances in a certain lots of Moderna vaccine vial.

 

All vaccine vials at the UTokyo vaccination site were checked, and vaccines in question were removed from the vaccination process so that they will not be administered to vaccinees.

  • Lot 3004667
    Used for a part of vaccinees on August 18, all vaccinees from August 19 through 25.
  • Lot 3004734 (not used at UTokyo)
  • Lot 3004956 (not used at UTokyo)