TOKYO, Aug 26 (NNN-NHK) – Japan’s health ministry said today, foreign materials were confirmed, in some portions of the unused doses of Moderna Inc.’s COVID-19 vaccine, and the use of around 1.63 million doses manufactured in the same production line, has been suspended as a precaution, local media reported.
The Ministry of Health, Labour and Welfare said, foreign substances have been confirmed since Aug 16, at eight vaccination sites in the prefectures of Ibaraki, Saitama, Tokyo, Gifu and Aichi.
Japanese drug-maker, Takeda Pharmaceutical Co., in charge of sales and distribution of the vaccine in the country, said, it has yet to see any reports of safety concerns and has reported them to the ministry yesterday.
The size of foreign substances found in 39 vials is believed to be a few millimetres.
“To date, no safety or efficacy issues have been identified,” Moderna said, adding, it is “carefully assessing this matter and at this point does not have further comments on root causes.”
The health ministry said, the 1.63 million doses of Moderna vaccine were made in the same production line, at the same time in Spain, and fall under three lot numbers — 3004667, 3004734 and 3004956, which has already been handed out to 863 vaccination centres across the country.
The ministry said, it believes the risk of safety issues is “not significant,” but will ask each facility that received the doses not to use them.
Over 10 million doses have already been used in the country since the Moderna vaccine accepted approval for emergency use in May, according to the government.
The Japanese government signed a contract with Moderna to receive 50 million doses of the vaccine, by the end of Sept. Currently those aged 12 and older can get shots of the vaccine.
Meanwhile, the health ministry revealed to the public the lot numbers of the contaminated vaccines, so that concerned individuals can check whether they received the potentially contaminated shots before the affected vaccine doses were suspended.
On similar abnormalities that may have been found in other countries, Moderna said, it monitors and expeditiously assesses questions it received about the products from global markets, and local authorities will make their own decisions about disclosure of information, following these assessments.
The problem was exposed to view at a time when Japan is struggling to control a peak in COVID-19 infection cases, as the government declared a plan yesterday, to put eight more prefectures under its COVID-19 state of emergency.
While vaccinations against COVID-19 are under way in Japan, the highly contagious Delta variant brought the surge of daily confirmed cases in many parts of the country.– NNN-NHK
