Man In Japan Dies After Receiving Dose Of Moderna's COVID-19 Vaccine Withdrawn From Use

JAKARTA - A 49-year-old man in Japan died last month after being given a dose of Moderna's COVID-19 vaccine which was later withdrawn from use by its distributor in the country, Japan's Ministry of Health said Monday.

Moderna and Takeda Pharmaceutical Co. said Wednesday last week they would recall three lots of vaccine after stainless steel contaminants were found in some bottles.

Quoting Kyodo News September 7, the dose of the dead man came from one of three lots that also contained the dose used in two men in their 30s who died in Japan after receiving a second injection in August, the ministry said. No foreign objects were found in any of the bottles.

"The 49-year-old man, who is allergic to buckwheat, received a second injection on August 11 and his death was confirmed the following morning," according to the ministry.

However, it said a causal relationship between the COVID-19 vaccination and his death was still unknown.

In announcing the recall, Moderna and Takeda said, "Stainless steel is routinely used in heart valves, joint and suture replacement and metal staples. Thus, it is not expected that the particles identified in this lot in Japan would result in an increased medical risk."

Even so, the cause of death in the three cases is still under investigation by the Sakura State authorities.

For information, COVID-19 vaccine manufacturer Moderna Inc., announced that it has withheld the supply of about 1.63 million doses of vaccine in Japan, following reports of bottle contamination with particulate matter suspected of being linked to a production line in Spain on Wednesday.

26, although Moderna said no safety or efficacy issues had been identified, the suspension was a fresh setback for the company, whose partners experienced production delays last month, disrupting supplies to countries, including South Korea.

"Moderna confirms it has been notified of a case of particles seen in vials of medicinal products from its COVID-19 vaccine," Moderna said in a statement.

"The company is investigating the reports and remains committed to working promptly with its partners, Takeda, and regulators to address this matter," he added, referring to Japan's Takeda Pharmaceutical.

It said contamination of the vaccine could be caused by a manufacturing problem in one of the production lines at its contract manufacturing site in Spain. It was not immediately clear if the issue had an impact on supplies to other countries.

The vaccine lot is feared to have 565,400 doses. However, in line with Moderna's caution, two lots adjacent to the contaminated lot were also suspended.

Takeda said it carried out an emergency check after particulates were found in many vaccine bottles at inoculation sites in Japan.

To note, between August 6 and August 20, the Moderna vaccine from the lot was used at a mass public vaccination center in Osaka, according to the defense ministry, which operates the center. The ministry did not say how many people were affected.