Modern vaccines are being prepared for application at a U.S. military vaccination center at Camp Foster on April 28, 2021 in Ginowan, Japan.
Carl Court | Getty Images
Japan’s Ministry of Health, Labor and Welfare suspended the use of more than 1.6 million doses of Modern Covid-19 vaccine on Thursday following reports of contaminated vials at several vaccination sites there.
Takeda Pharmaceuticals, which distributes the vaccine in Japan for Modern, said it notified the ministry after several vaccination sites reported an unspecified foreign object found in a specific batch.
“We requested that Moderna, the owner and manufacturer of the product, conduct a thorough investigation to determine the exact root cause of the problem,” Takeda said in a statement.
Takeda also said he is not aware of any “significant safety concerns” arising from the contaminated doses.
Moderna said she has been notified of the problem and is studying it.
“The company is investigating the reports and remains committed to working quickly with its partner, Takeda, and regulators to address them,” Moderna wrote in a statement.
Moderna said she believes the manufacturing problem arose on one of the lines used at its contract manufacturing site 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 with great caution, Moderna has suspended this lot and two adjacent lots,” the company said.
Rovi, the Spanish pharmaceutical company that bottles Moderna vaccines, said it is investigating the situation and said the contamination appears to be limited to a few batches destined to be distributed in Japan, according to Reuters. Rovi shares fell 13% in mid-day trading.
Takeda discovered the contaminated roads on Aug. 16 and reported them to Japanese officials Wednesday, according to NBC news. The company said the delay was due to the need to confirm road pollution and the affected countries.
Japanese Cabinet Secretary-General Katsunobu Kato told reporters Thursday that contaminated doses were administered to an unknown number of Japanese residents, although there have been no reports of adverse effects, according to the New York Times.
Doses of the contaminated site were used at a vaccination site in Osaka run by the Japanese defense ministry, according to Reuters. The doses used came from the contaminated batch, but it is unclear if any doses used were contaminated. Doses were administered at the site between August 6 and 20, but no safety issues have been reported.
Doses of contaminated batches were to be used at mass vaccination sites of large companies and universities, but all have stopped, according to Reuters.
All contaminated roads were manufactured in factories in Spain. It is still unclear whether other countries besides Japan have been affected, although the European Medicines Agency said it is also investigating the issue.
“The EMA is investigating the matter and has asked the marketing authorization holder to provide information on any possible impact on batches supplied to the EU, as well as details on the ongoing investigation into the root cause. “The agency said in a statement to Reuters.
Moderna told CNBC that “there is no evidence” that other countries may have been affected because “the batch comes from a batch that was manufactured exclusively for Japan.”
There is no “expected deadline for completion” of the investigation into the contaminated doses, but Moderna says it is working with its contract manufacturer, its distributor and the government.