Recall Notification of Lot #000190A

Moderna and ROVI Pharma Industrial Services, S.A.U. today announced a recall of one lot (lot #000190A) of the Moderna COVID-19 vaccine (Spikevax®)

Madrid – 08 April, 2022 - Moderna and ROVI Pharma Industrial Services, S.A.U. today announced a recall of one lot (lot #000190A) of the Moderna COVID-19 vaccine (Spikevax®). The lot is being recalled due to a foreign body being found in one vial in the lot manufactured at the Company’s contract manufacturing site, ROVI, in Spain. The impacted vial was punctured and was not administered.
Moderna, through its marketing authorization holder, Moderna Biotech Spain, S.L., and ROVI,were alerted to this issue through a product complaint from a vaccination center in Málaga, Spain. The vial was returned for forensic assessment and investigation. This lot, which consisted of 764,900 doses, was distributed in Norway, Poland, Portugal, Spain, and Sweden from 13-14 January 2022.
Moderna conducted a cumulative search of its global safety database, and no safety concerns were reported in individuals who received the Moderna COVID-19 vaccine from this lot. To date, no safety or efficacy issues have been identified.
More than 900 million doses of the Moderna COVID-19 vaccine have been administered to date worldwide. Moderna does not believe that this poses a risk to other vials in the lot and does not believe that this affects the significant benefit/risk profile of the vaccine.
Given the Company’s priority to assure quality, and out of an abundance of caution, this lot is being recalled. Moderna is proactively communicating with health authorities as the investigation proceeds. Moderna and Rovi remain committed to working transparently and expeditiously with regulators to address any potential concerns.
Direct consignees or healthcare professionals that have impacted product with this lot number should contact with any inquiries regarding recalled product.

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