Svein Rune Andersen, Director of the Norwegian Medicines Agency, informs Dagbladet that the European Medicines Agency (EMA) has found the reason why black particles have ended up in Moderna vials in Japan. It is assumed that the particles do not pose an increased risk to the recipient of the vaccine.
Knut Jønsrud, head of the vaccine supply at the Norwegian Institute of Public Health, tells Dagbladet that three similar findings have also been made in Norway, but that it has no connection with the recent findings in Japan.
– FHI has registered three complaints about particles in the Moderna vaccine, says head of the vaccine supply at FHI, Knut Jønsrud, to Dagbladet.
– Unexpected findings of particles that have been observed in Japan are followed up by Japanese drug authorities against Moderna. The issue is also followed up by the European Medicines Agency (EMA). The relevant parties have not been sent to the EU, says Jønsrud.
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The cause found
Recently, the pharmaceutical companies Moderna and Takeda recalled three batches of Moderna’s corona vaccines after the discovery of small black particles in Moderna vials in Japan. Andersen at the Norwegian Medicines Agency says that EMA has found that it is due to manufacturing errors at the pharmaceutical company Rovi’s factory in Spain.
– Now EMA in collaboration with the manufacturers has investigated the cause of the occurrence of black particles in Moderna vials in Japan, Andersen says to Dagbladet and continues:
– As a result of these investigations, they have found that the black particles are metal particles that have formed as a result of friction in a metal component in one of the production lines in the Spanish factory. This manufacturing defect occurred because the metal component had been installed incorrectly.
The Japanese authorities stopped vaccination with vaccines from the relevant parties after the discovery of black particles in a total of 39 Moderna vials. The findings were made in both used and unused vials. Andersen points out that now that the EMA has found the cause of the error, the manufacturer can ensure that it does not happen again.
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Found in Norway
One of the findings that has been made in Norway, was made on March 9 by Oslo Municipality. Two days later, they reported the discovery of black particles in a Moderna vial to FHI, shows e-mails that Dagbladet has had access to.
The municipality stated that the vial in question had been discarded, whereupon FHI asked them to send it to them. Such incidents are routinely registered as a complaint against the manufacturer, which follows up the deviation in more detail.
The presence of black particles in Moderna vials in Norway may be due to the fact that rubber particles have come loose from the rubber cap after perforation, ie when the syringe needle penetrates the rubber cap. On a general basis, Andersen says that this can happen.
– This can also occur, especially if you stick the needle through the rubber lid many times. These rubber caps must withstand repeated perforation, but this can of course happen, says Andersen.
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Probably low risk
Director Andersen talks about how to assess the risk associated with the metal particles.
– EMA believes that there is a very low risk of side effects due to injection with Moderna vaccine with metal particles. These metal particles are small and are made of surgical steel, which is the quality also used in surgery.
– I doubt that Moderna vaccines from contaminated vials have been given in Norway. Our healthcare professionals are very good at checking the vials before drawing up the vaccine doses, and there is thus a very low probability that vaccines with black particles have been injected in Norway.
Andersen also states that vaccines are monitored extra closely by the drug authorities. In addition to the quality tests performed by the vaccine manufacturer, each batch of vaccines is tested by an independent government laboratory in Europe before they are used, he states.
