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Japan suspended the use of 1.6 million doses of Moderna COVID-19 vaccines
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Japan suspended the use of 1.6 million doses of Moderna vaccines due to foreign matter in vaccine bottles.
According to Nikkei News, The Ministry of Health, Labor and Welfare announced on the 26th that it will postpone about 1.6 million doses of new coronavirus vaccine made by US Moderna, saying that it was found to be contaminated with foreign substances. Some have already been vaccinated, but no health hazards have been reported at this time. The details of the foreign matter are being confirmed by Moderna.
Since mid-August, Takeda Pharmaceutical Company Limited , which handles domestic supply, has reported foreign matter contamination from eight venues in five prefectures: Tokyo, Saitama, Aichi, Ibaraki, and Gifu. It includes large-scale workplaces and local government venues. In each case, a foreign substance was found by confirmation before inoculation.
Inoculation is postponed for the production number 3004667 (about 570,000 times), which was reported to be contaminated with foreign substances, and the vaccines of 3004734 (about 520,000 times) and 3004956 (about 540,000 times) manufactured on the same line. All are produced in Spanish factories. Delivery destinations are 863 venues. It is said that there are reports of rubber pieces being mixed overseas as well.
The Ministry of Health, Labor and Welfare explains, “I think that foreign substances were mixed in during the manufacturing process. The health risk is not so great.” We have determined that other Moderna vaccines can be used without problems. Takeda Pharmaceutical will continue to supply alternatives. “We will try to minimize the impact (such as delays in vaccination).”
Moderna: No safety or effectiveness issues
On the 25th, Moderna said that a part of the company’s new coronavirus vaccine supplied to Japan was found to be contaminated with foreign substances. No safety or efficacy issues have been identified at this time. “
The company’s public relations responded to inquiries from the Nihon Keizai Shimbun. “We have confirmed that there have been multiple reports of particulate matter in one of the production lots of vaccines distributed in Japan. Two adjacent vaccines to prioritize quality assurance. We have also withheld the inoculation of production lots. “
Regarding the future, he said, “We are currently investigating the problem and will respond promptly and transparently with the affiliated Takeda Pharmaceutical Company and regulatory authorities.”
Moderna has outsourced vaccine filling and finishing processes to the Spanish pharmaceutical company Laboratorios Pharmaceuticos ROVI.
(source:internet, reference only)