The first results of the investigations into the contamination of Moderna doses at the Rovi factory rule out that this incident is related to the death of two Japanese after receiving the second dose of the vaccination schedule. The particles are stainless steel and broke off on the cap assembly line. “At this time, there is no evidence that the two tragic deaths that followed the administration of the Moderna CCovid-19 vaccine (from lot 3004734) were in any way related to the administration of the vaccine. The relationship is currently considered a coincidence”, explain the companies Moderna and Takeda. The Rovi company has spent two days (yesterday and today) improving its data on the stock market. Between the two days it has grown by more than 7%.
The substance found is grade 316 stainless steel. This material is used in both the food and medical industries. “Metal particles of this size injected into a muscle may cause a local reaction, but are unlikely to cause other adverse reactions beyond the local injection site,” according to the research. “Stainless steel is commonly used in heart valves, joint replacements, and metal sutures and staples. As such, injection of the particles identified in these batches into Japan is not expected to result in increased medical risk,” they add in their statement. the companies.
The investigation into how the batches could have been contaminated has also been disclosed by Rovi to its partner Moderna. The most probable cause of the particles identified in batch 3004667 is related to friction between two metal parts installed in the capping module of the production line due to incorrect installation.
The two parts are the star wheel and the cap feeder part that feeds the caps into the star wheel. “It is believed that everything occurred during the assembly of the line before the production of batch 3004667 and was the result of incorrect alignment during a line change before starting this batch,” the Spanish firm explained to Takeda and Moderna.
Based on Rovi’s analysis, the manufacturing issue only affected the three batches that were included in the suspension. The López-Belmonte firm has taken the following measures to correct and prevent future defects: complete inspection of the manufacturing line; improve the standard operating procedure for manufacturing line change; and establish alert inspection limits in the automatic visual inspection, as an internal control of the process.
For its part, Takeda, in charge of distributing Moderna’s vaccine in Japan, plans to initiate the withdrawal of the three suspended batches (3004667, 3004734 and 3004956) from the market as of September 2.
Japan continues to investigate
The Government of Japan indicated yesterday that it will continue to investigate possible reactions in patients to Moderna’s vaccines, after the company stated that the steel particles found in some of its doses do not pose a health risk. A spokesman for the Japanese Ministry of Health said that the cases of possible reactions to the vaccines, including the two deaths, are still being analyzed. The same source did not want to comment on whether the Japanese authorities are contemplating imposing a sanction on pharmaceutical companies.
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