In Japan, about 1.63 million doses of the corona vaccine from US Moderna have been withdrawn after reports of contaminants in vials of the vaccine.
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Eight Japanese vaccination centers had reported that some unused vials of the vaccine contained “foreign matter” several millimeters in size, Japanese media reported. The contamination has been confirmed in 39 bottles since August 16, and distributor Takeda reported it to the health ministry on Wednesday, it said. The Ministry and Takeda have subsequently decided to withdraw approximately 1.63 million doses as a precaution and also called on not to use any dose that shows abnormalities.
US pharmaceutical company Moderna confirms it has received “multiple complaints” about “particulate matter” in its vaccine vials distributed in Japan, but says that “no safety or efficacy issues” have been found so far in connection with those reports. The ministry also confirmed this.
Problem in Spain
The vaccine lot complained of contained 565,400 doses and out of an “abundance of caution,” Moderna has put that lot and two adjacent lots on hold, a spokesman said. According to the spokesperson, Moderna believes that a “production problem” on one of the lines at a factory in Spain could be the cause.
The doses from lots 3004667, 3004734 and 3004956 – all produced in Spain – have already been distributed to 863 vaccination centers across Japan, and the Japanese Ministry of Health will ask all those centers not to use the vaccines. The lot numbers were released so that concerned people can check if they were receiving a potentially contaminated vaccine before the doses were withdrawn.
Research
“The company is investigating the reports and remains committed to working transparently and promptly with its partner, Takeda, and regulators to address potential concerns,” said Moderna.
The Ministry of Health says it is trying to minimize the impact on Japan’s vaccination campaign and will work with Takeda to provide replacement doses.The ministry has not stopped the use of vaccines from other batches, because it considers them safe.
About 10 million doses of the Moderna vaccine have been administered in Japan since the emergency approval in May.
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