Moderna recall COVID vaccines after stainless steel contaminants found

pharmafile | September 2, 2021 | News story | Medical Communications  

Moderna and Takeda Pharmaceutical on Wednesday said they are working with Japanese authorities to recall three batches of their COVID-19 vaccine after an investigation found stainless steel contaminants in some vials.

Japanese authorities had suspended use of these batches of Moderna shots, containing 1.63 million doses, last week after being notified of the contamination issue.

Japan’s health ministry said on Wednesday, based on information from the companies’ investigation, that it did not believe the particles of stainless steel pose any additional health risk.

In a joint statement with Takeda, the company that distributes the vaccine in Japan, Moderna said the most probable cause of contamination was related to friction between two pieces of metal in the machinery that puts stoppers on the vials.

The statement said: “Stainless steel is routinely used in heart valves, joint replacements and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk”.

A joint investigation into the contamination was launched by Moderna, Takeda, and Spanish manufacturer Rovi which operates the plant where the contamination occurred.

Administration of the Moderna shots from the three lots was suspended in Japan after 39 vials were found to contain foreign material. All the vials came from a single lot, but shots from two other lots from the same Rovi manufacturing line were suspended as a precaution.

Use of the Moderna vaccine from different batches also was temporarily halted in three regions in Japan this week. In some cases, foreign substances were found in unused vials, while others appear to have been the result of incorrectly inserted needles causing bits of the vials’ rubber stopper break off.

This contamination issue has gained more attention after the health ministry reported the deaths of two men, aged 38 and 30, in August within days of receiving their second Moderna doses. Each had received a dose from one of the suspended lots. The cause of death in these two cases is still currently under investigation.

Moderna and Takeda said that there was no evidence the fatalities were caused by the vaccine, saying “The relationship is currently considered to be coincidental.

About 500,000 people have received shots from the three suspended Moderna batches, and Moderns said it cannot confirm how many doses were distributed from the batches.

Kat Jenkins

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