The vaccines Moderna shipped to Japan contained “steel particles,” the lab reported.

The American laboratory Moderna reported Wednesday that contaminated batches of its anticovid vaccine sent to Japan contain stainless steel particles. But he said he does not expect this to represent “an undue risk to patient safety.”

The drugmaker faces a major setback in Japan, which has suspended more than 1.6 million doses of Moderna’s vaccine after detecting “foreign substances”.

Authorities are also investigating the deaths of two men who received doses from a contaminated batch, although the cause of their death is unknown at this time.

“Manufacturing failures”

In a joint statement with its Japanese partner Takeda, Moderna said the contamination in one of the three suspended batches dates back to production line failures of a factory run by its Spanish entrepreneur, ROVI Pharma Industrial Services.

“The rare presence of stainless steel particles in the modern Covid-19 vaccine does not pose an undue risk to patient safety and does not adversely affect the risk / benefit profile of the product,” a statement said.

Metal particles injected into a muscle can cause a localized reaction, but they are unlikely to cause anything else, he added.

“Stainless steel is commonly used in heart valves, joint prostheses, sutures and metal staples. As such, injection of the particles identified in these lots in Japan is not expected to result in an increased medical risk,” did he declare.

Moderna added that, for the moment, there is no evidence that the two deaths are related to the vaccine and “it is currently considered a coincidence.” An investigation is underway.

The results of the scans, which were also collected by Japan’s health ministry, come after the Tokyo government announced last Thursday that it had blocked 1.63 million doses of Moderna after foreign particles were seen in 39 vials that were going to be used in different parts of the country.

The vaccines withdrawn corresponded to three batches produced at the same time and in the same factory de Rovi, and were blocked as a precaution after detecting irregularities in bottles corresponding to one of the three lots.

About 46% of Japan’s population was fully immune to the coronavirus, at a time when the country is experiencing a record increase in infections due to the more contagious delta variant.

The pandemic has already killed some 16,000 people in Japan, which has strict restrictions across much of the country.

Source: AFP and EFE

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