Moderna vaccines are being prepared for use at a U.S. military vaccination center at Camp Foster on April 28, 2021 in Ginowan, Japan.
Carl Hof | Getty Images
Japan’s Ministry of Health, Labor and Social Welfare suspended the use of more than 1.6 million doses of Moderna’s Covid-19 vaccine on Thursday after reports of contaminated vials at multiple vaccination sites there.
Takeda Pharmaceuticals, which sells the vaccine for Moderna in Japan, said it notified the ministry after multiple vaccination sites reported an unspecified foreign object found in a specified lot.
“We asked Moderna, the owner and manufacturer of the product, to conduct a thorough investigation to determine the exact cause of the problem,” Takeda said in a statement.
Takeda also said he was not aware of any “significant safety concerns” related to the contaminated cans.
Moderna said it had been informed of the problem and would investigate it.
“The company is investigating the reports and remains committed to working expeditiously with its partner Takeda and regulators to address this,” Moderna wrote in a statement.
Moderna said it believed the manufacturing problem was caused in one of the lines used at its contract manufacturing facility in Spain, adding that it did not appear to affect the safety or effectiveness of the shots.
“Given the company’s priority to ensure quality, and out of great caution, Moderna has put this lot and two adjacent lots on hold,” the company said.
Rovi, the Spanish pharmaceutical company that bottles Moderna vaccines, said it is investigating the situation and that, according to Reuters, the contamination appears to be limited to a few batches to be marketed in Japan. The Rovi share lost 13% in midday trading.
Takeda discovered the contaminated vials on Aug. 16 and reported them to Japanese officials on Wednesday, according to NBC News. The company said the delay was due to the need to confirm contamination of the vials and the affected countries.
Japan’s top cabinet secretary, Katsunobu Kato, told reporters Thursday that contaminated doses were administered to an unknown number of Japanese residents, despite no reports of side effects, according to The New York Times.
Doses from the contaminated batch were administered between August 6 and 20, according to Reuters, at a vaccination site operated by the Japanese Ministry of Defense in Osaka, but it is unclear whether any of the doses used were contaminated.
Cans from the contaminated batch were supposed to be used at large corporations and universities’ bulk vaccination sites, but all have stopped, according to Reuters.
All contaminated vials were made in Spain. It is still unclear whether other countries besides Japan are affected, although the European Medicines Agency has announced that it will also investigate the problem.
“The EMA is investigating the matter and has requested the marketing authorization holder to provide information on possible effects on batches shipped to the EU, as well as details of ongoing root cause research,” the agency said in a statement to Reuters.
Moderna told CNBC that there was “no evidence” that other countries could be affected because “the batch came from a batch made exclusively for Japan”.
Moderna said there is no “expected timeframe to complete” the contaminated can investigation, but rather is working with its contract manufacturer, distributor and government.