LABORATORIOS FARMACEUTICOS ROVI S.A controversies

Moderna vaccine particulate contamination and recall in Japan

In August 2021, Japan suspended use of three lots of Moderna’s COVID-19 vaccine after foreign particulate matter was observed in unused vials. The affected vaccine had undergone fill-and-finish operations at ROVI’s Spanish facility. ROVI investigated the incident with Moderna, Takeda and health authorities. The investigation identified a manufacturing-line problem involving friction between metal components in a capping module. The lots were voluntarily recalled as a precaution, and the investigation did not establish that the reported deaths of two recipients were caused by the vaccine.