Moderna and its Spanish contractor issued a voluntary recall of 764,900 doses of COVID-19 it distributed in January to five countries.
The Spanish manufacturer Moderna contracted, ROVI, got a product complaint from a Malaga, Spain vaccination center about a vaccine contamination.
ROVI’s recall notification explained they issued the recall after a foreign body was found in one vial in the lot manufactured at the ROVI manufacturing site, ROVI. The impacted vial was punctured and not administered, the company claimed in its statement. Company officials did not immediately identify the foreign substance that contaminated the punctured dose.
The damaged vial was one of 764,900 doses in a lot that was distributed in Norway, Poland, Portugal, Spain, and Sweden January 13, 14. It was returned to the company for forensic assessment and investigation, the company said in its recall notice.
“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,” the company statement said. “To date, no safety or efficacy issues have been identified.”
The company emphasized that more than 900 million doses of the Moderna COVID-19 vaccine have been administered so far, 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.”
ROVI’s statement explained the recall was being conducted “out of an abundance of caution” and they are working with regulators while they investigate.
Last year, several lots of Moderna’s COVID-19 vaccines were recalled by Japanese authorities after an investigation found stainless steel contaminants in some vials. The recalled batches were manufactured by the same Spanish company, ROVI, according to a report from “The Epoch Times”.
Japanese pharmaceutical company Takeda Pharmaceutical reportedly traced the contamination back to a production run from ROVI. The findings were discovered by an investigation carried out by the two companies, not the Japanese health ministry, according to the Times report.
Two people died within days of their second Moderna shot last year but Japan and the vaccine maker found no safety issues, according to an August 2021 Reuters report.