There Is Contamination In Its COVID-19 Vaccine, Moderna Suspends 1.63 Million Doses In Japan

Ilustrasu Vaksin Moderna. (Wikimedia Commons / Navy Medicine)

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

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

The situation has also led several Japanese companies to cancel their planned COVID-19 vaccinations for workers this Thursday, as most of the doses in question have been supplied to mass vaccination sites and workplaces in Japan.

"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 partner Takeda and regulators to address this," he added, referring to Japan's Takeda Pharmaceutical (4502.T).

It said the contamination could have been 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.

Moderna did not immediately respond to a request for comment from Reuters. Meanwhile, Rovi Spain, which packs vaccines into bottles for markets other than the United States, has yet to comment on this.

It is known, the vaccine lot that is feared has 565,400 doses. However, in line with Moderna's caution, two lots adjacent to the contaminated lot were suspended.

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

Meanwhile, Japan's Ministry of Health has decided to withdraw some doses as a precaution after consulting Takeda, but said it would seek to minimize the impact of the recall on its planned COVID-19 vaccination programme.

Separately, Chief Cabinet Secretary Katsunobu Kato said there were no reported cases of health problems linked to the contaminated injection.

To note, between August 6 and August 20, the 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.