Due to misaligned bottling components, 1.6 million doses of Moderna’s vaccine were withdrawn for containing stainless steel particles.The Kanagawa Prefectural authorities stated in a statement on Tuesday that a pharmacist discovered many black particles in one vial when testing for foreign substances before using the vaccination.
Moderna is a pharmaceutical and biotechnology business based in Cambridge, Massachusetts, that has been developing its vaccine.”The cause could be a manufacturing fault” according to Moderna and Rovi, a Spanish pharmaceutical company that bottles Moderna vaccines. The European safety inspectors have initiated an investigation.
According to the joint statement by the US drugmaker along with its Japanese distributor Takeda Pharmaceutical , “the particles do not pose an unreasonable danger to patient safety and are unlikely to cause any adverse effects beyond the local site of injection.”
Two people in Japan died after receiving doses from these lots. The fatalities were described as tragic but appeared to be “coincidental,” according to the company. They also said that there is no evidence linking them to the vaccination.
However, based on the investigation’s results, the health ministry said it will evaluate possible administrative penalties against Takeda, Japan’s largest pharmaceutical company.
Following the ministry’s Aug. 26 action, all Nippon Airways and a number of municipal governments stopped using the Moderna vaccine.