Moderna has recalled one lot of its COVID-19 vaccine, Spikevax, after a foreign body was found in a vial produced by CDMO Rovi.
Moderna and Spanish contract development manufacturing organization (CDMO) Laboratorios Farmacéuticos Rovi jointly announced that they have recalled lot #000190A of Spikevax in Europe, which consisted of 764,900 doses.
The firms were made aware of the issue through a product complaint from a vaccination center based in Malaga, Spain. The dose in question was returned for forensic assessment and the affected vial was punctured and not administered.
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The lot was distributed in Poland, Portugal, Spain, Norway, and Sweden between the 13th-14th January 2022.
According to Moderna, there has been no safety concerns reported in individuals who received the COVID-19 vaccine from this lot. Additionally, it maintained that it does not believe this poses a risk to other vials in the lot and does not think it affects the benefit/risk aspect of the jab.
Rovi joined the list of firms supporting the production of Moderna’s vaccine mRNA-1273 in July 2020 by providing fill-finish and packaging services for the company from its facility in Madrid, Spain.
In August 2021, Japan put 1.6 million doses of the Moderna vaccine on hold after “foreign materials” were discovered in approximately 565,000 vials.
Rovi and Moderna conducted an investigation after particulate matter was identified in vials of the vaccine distributed in Japan and concluded that it was most probable that friction between two pieces of metal installed in the stoppering module of the production line due to an incorrect set-up caused this issue.
Moderna says it is communicating with various health authorities as the investigation continues and maintained that itself and Rovi still remain committed to working with regulators to address any potential problems.