Japan suspends 1.63 million Moderna doses over contamination concern
Japan has suspended the use of about 1.63 million doses of Moderna's COVID-19 vaccine due to reported contamination, as the country grapples with surging infections.
Japanese drugmaker Takeda Pharmaceutical Co., which is in charge of distributing the Moderna vaccine in Japan, said in a press release Thursday that it has received reports of foreign substances in some unused vials at multiple inoculation sites. Although some doses might have been administered, Takeda said there have been no reports of safety concerns tied to the affected vials so far.
After consulting with Japan's Ministry of Health, Labor and Wealth, Takeda said it decided as a safety precaution to stop using doses from three separate lots, manufactured in the same production line as the contaminated vials. The company said it has requested Moderna to conduct an emergency investigation into the issue.
For doses from non-suspended lots, Takeda urged people to check the vials for discolouration, foreign substances or other abnormalities before continuing to use. Meanwhile, the Japanese health ministry said it will work with Takeda to supply alternative doses in an effort to minimize the impact on the country's vaccination progress.
![PHOTO: This June 14, 2021, file photo shows a vial of Moderna's COVID-19 vaccine that is being administered for flight attendants of Japan Airlines at Haneda Airport in Tokyo.](https://s.abcnews.com/images/Health/moderna-covid-vaccine-vial-japan-ap-210_hpEmbed_20210826-041510_3x2_992.jpg)
Moderna told ABC News that it has put the 1.63 million doses on hold in Japan after being notified that some of the vials may have been contaminated. One of the three lots received "several complaints of particulate matter" in its vials, the American drugmaker said, while the two other adjacent lots were put on hold out of "an abundance of caution" and for continued assurance of quality.
According to Moderna, the manufacturing issue may have come from one of the lines used at its contract manufacturing site in Spain. The Massachusetts-based company said it is looking into the contamination reports and "proactively communicating with Japan’s health authorities and its partners as the investigation proceeds." Moderna added that it remains "committed to working transparently and expeditiously" with its Japanese distribution partner and with regulators to address any potential concerns. No safety or efficacy concerns have been identified so far, the company said.
Moderna noted that the pause in Japan does not impact doses distributed in the United States, or put the American supply at risk in any way.