Contemporary vaccines produced in Spain that were blocked in Japan after impurities in vials contained "stainless steel particles," the pharmaceutical company announced today, which added that the anomaly does not represent a health risk.
These are the conclusions of research and laboratory analyzes conducted by the American pharmaceutical and its distributor in Japan, Takeda, following the Japan Government's decision to block 1.63 million doses of the vaccine after detecting foreign substances in some Flasks.
It is believed that the remains come from "an apparatus of the production chain" and "do not impose an undue risk from the medical point of view," according to a joint statement published this Wednesday by modern and Takeda after the investigation in which it has also Participated the Spanish pharmaceutical Rovi, which produces and packages the vaccine for the Japanese market, among others.
The "most likely" cause of steel remains found in vials of anticovid vaccines is the friction between pieces of this material due to a technical failure in the production chain, a problem that would have reached one of the three lots of modern Affected, according to the statement.
According to independent laboratory analyzes, it is "stainless steel of type 316", a material commonly used in manufacturing, food industry or present in medical implants and other health devices.
"After a healthcare evaluation by modern and Takeda, the scarce presence of steel particles in vaccines does not represent an abuse for patient safety and does not adversely affect the risk and benefit profile of the product," says the release.
The two pharmaceuticals add that in case small steel particles were injected into a muscle, "a local reaction could occur, but it is unlikely to result in other adverse reactions."
The results of the analyzes, which have also been collected by the Junite Ministry of Health, arrived after last Thursday Japan announced the blockade of 1.63 million doses of modern after observing foreign particles in 39 vials that were going to be Used at different parts of the country.
The withdrawn vaccines corresponded to three batches produced at the same time and on the same ROVI plant, and were blocked as a precautionary measure after the irregularities in jars corresponding to one of the three batches detect.
The Japanese authorities also investigate the death of two people who were vaccinated with one of the three lots before they became withdrawn, to try to clarify if there is any connection between deaths and inoculation.
Takeda and modern pointed out that for now "there is no evidence" that deaths could have been caused by vaccines, although they emphasize the importance of carrying out a formal investigation to confirm it.
Date Of Update: 05 September 2021, 02:34
