Nearly 765,000 doses of Moderna COVID vaccine recalled due to contamination

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WASHINGTON, April 9: Moderna and ROVI Pharma Industrial Services (S.A.U.) – a specialized Spanish pharmaceutical company, on Friday announced the recall of one lot of Moderna Covid- 19 vaccine (Spikevax) due to a foreign body being found in one vial in the lot. The lot (#000190A) is manufactured at a ROVI site in Spain, the US biotechnology company, Moderna, said in a press release, noting that 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 Malaga, Spain. The vial was returned for forensic assessment and investigation, the statement noted. 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, according to the statement. 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, it added., (KUNA)

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