Tokyo, Sep 1 (EFE).- Spanish-produced vials of the Moderna vaccine that were blocked in Japan after the discovery of impurities have been found to contain particles of high-grade stainless steel, according to analysis published Wednesday.
The contamination most likely resulted from friction between two metal components of the machine sealing vials on the production line, pharmaceutical firms Moderna and Takeda said following root cause analysis by Rovi, Moderna’s Spanish manufacturing partner.
Japanese authorities halted the distribution of around 1.63 million doses of Moderna after contaminants were detected in a number of batches packaged by Rovi.
“??According to Moderna’s independent analysis, the particle from lot 3004667 has been thoroughly analyzed and is confirmed to be grade 316 stainless steel.”
Moderna and Takeda, which distributes the vaccine in Japan, said: “the rare presence of stainless steel particles in the Moderna COVID-19 vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product.”
The contaminant material affected three lots of the Moderna supply in Japan, denting the country’s relatively sluggish vaccine drive.
The death of two recipients of the affected Moderna vaccines in Japan is thought to be coincidental, the statement said.
Japan’s health ministry late Tuesday said it had discovered impurities in a fourth batch of Moderna sent by Rovi, adding in this case it appeared to contain fragments of rubber stopper.EFE