‘Human Error’ Caused Contamination Of Moderna Vaccines In Japan, Distributor Takeda Says

Japan's Takeda Pharmaceutical, which distributes Moderna shot in Japan, blamed Friday human error for metal contaminants found in some Moderna Covid-19 vaccine batches. This led to the withdrawal from Japan of 1.63 Million doses of the mRNA-shot in August.

Over contamination concerns, 1.63 million doses (of the Moderna vaccine) were withdrawn by Japan in August. AFP via Getty Images

The Key Facts

According to Reuters Takeda stated in a new report, that while contaminants were discovered in vaccine vials at a Spanish factory, doses from the same batch of vaccine were allowed to ship to Japan. Moderna and Rovi conducted an investigation and found that the problem was due to incorrect assembly. This was due to a 1mm gap between the stopper lids of the vials and machinery used to insert them. The manufacturing problem affected five lots of vaccines. Three of them were sent to Japan following inspection and the rest were later recalled. After failing inspections on July 2, Rovi held the fourth and fifth lots back. Takeda as well as the Japanese health ministry were informed. In Japan, the contaminants were found in at least 39 vials by Rovi in late August. Testing revealed that they were made of stainless steel.

Important Background

After contaminants were found in vials, the Japanese government stopped the distribution of 1.63 million Moderna vaccine doses. Moderna stated at the time that 565,400 doses of the vaccine were from the same production line, but it also pulled two other lots out of an abundance caution. Japanese health officials are now investigating the deaths of at most two men who received doses from the suspended lot. Experts were skeptical that the contamination could have caused the deaths of the two men, but there were concerns it might increase vaccine hesitancy. A study by Lancet published last year shows that Japan has the lowest level of confidence in vaccine safety or effectiveness.

Big Number

59.5% According to Bloomberg's tracker, that is the proportion of Japans population who have been fully vaccinated against Covid-19. Although initially criticized for slow progress, Japan's vaccine rollout has been rapid and steady over the past few months. A sharp decline in new infections has been observed, which has led to the government removing all emergency pandemic measures.

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Takeda, Japan: "Human error" caused Moderna vaccine contamination (Reuters).

Japan Stops the Use of 1.6 Million Moderna Doses Due to Contamination Concerns. (Forbes).

Japanese Health Minister: Vaccine Contaminants Most Likely Caused by Incorrect Needle Usage, No Safety Concern With Moderna Shot (Forbes).

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