Japan suspends use of vaccine lots from Moderna due to contamination

Japan has suspended the use of 1.63 million doses of Moderna’s Covid-19 vaccine because of reports of contamination in several vials of immunizer. The information was confirmed by the pharmaceutical company Takeda and the Ministry of Health of the country last Thursday night (26) at local time.

Takeda is the company responsible for the sale and distribution of Moderna’s vaccine in Japan. The company stated that the suspension of the use of doses occurred after receiving reports from different vaccination centers. The documents reported that foreign substances had been found inside unopened vials of vaccine.

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After consultations with the Japanese Ministry of Health, the company decided to suspend the use of three batches of the vaccine as of Thursday. The company also said that Moderna requested an urgent investigation into the contamination. In a statement, the American company said that the contamination was something punctual and isolated from a batch distributed in Japan.

Contamination in Spain

Pharmaceutical company Rovi's headquarters in Granada, Spain
Part of Moderna’s vaccines distributed outside the United States are distributed by pharmaceutical company Rovi, in Spain. Credit: Rovi/Disclosure

Moderna believes that the problem was caused in one of the production lines of a third-party manufacturing unit located in Spain. The company pointed out that, despite the foreign substances in the batches, no safety or efficacy issues were identified in the immunizing agents. However, as a precaution, they decided to suspend use to investigate the case.

Takeda and Moderna did not go into details about the nature of the contamination, but a Japanese government spokesman said that so far there had been no reports of health problems stemming from the contaminant. However, the representative said that people should consult a doctor if they experience any symptoms outside those specified in the vaccine package insert.

According to Japanese TV station NHK, the contaminants were found in at least 39 unopened vials at eight vaccination posts in central Japan, including Tokyo. According to the Ministry of Defense, doses from one of the suspended batches were administered at a large paste vaccination center in Osaka city.

Case under investigation

However, nurses did not find any visual evidence of the presence of contaminants in vaccines that were applied at Ministry of Defense vaccination posts in Osaka city. A second vaccination center in the folder, located in Tokyo, did not receive any doses that were part of the affected flocks.

The contamination reports involve doses of the Moderna vaccine manufactured by Spanish pharmaceutical Rovi, a technical partner that prepares immunizers outside the United States. In a statement, the Spanish Ministry of Health stated that Rovi is investigating the causes of this possible contamination under the supervision of the Spanish Medicines Agency (AEMPS).

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The Japanese Ministry of Health and Takeda are working together to secure alternative doses for the affected vaccination posts. The government’s intention is to avoid interrupting the country’s vaccination program, which already has around 43% of its population fully immunized, an encouraging fact, given the slow start of vaccination in Japanese territory.

Via: Medical Xpress

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