The U.S. pharmaceutical and biotechnology company Moderna Inc. on Friday issued a recall in Europe involving 764,900 doses of its COVID-19 vaccine “Spikevax” after contaminants were discovered in a vial.
“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,” Moderna and Spain’s ROVI Pharma Industrial Services said in a joint statement.
The drugmaker did not specify what kind of foreign substance was found and had recalled the whole lot out of “an abundance of caution.”
The contamination was traced in just one vial of the batch and investigators do not believe the contamination posed a risk to other vials in the lot.
“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.
The lots were distributed from Jan. 13 to Jan. 14 in Norway, Poland, Portugal, Spain, and Sweden. To date, more than 900 million doses of the Moderna COVID-19 vaccine have been administered worldwide.
Last year, Moderna had several lots of its COVID-19 vaccines 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.
Japan’s biggest drugmaker, Takeda Pharmaceutical, said in a statement the contamination was traced back to the production run by ROVI. The findings were discovered by an investigation carried out by the two companies, not the Japanese health ministry.
Three men in Japan had fallen severely ill in August 2021 after being administered a second dose of the now-recalled COVID-19 vaccine and died shortly after. Takeda said in a statement at the time there is no evidence they are linked to the vaccine, Reuters reported.
“Stainless steel is routinely used in heart valves, joint replacements, and metal sutures and staples. As such, it is not expected that injection of the particles identified in these lots in Japan would result in increased medical risk,” the company said.
The first two deaths reported in the country linked to contaminated Moderna doses were two men, aged 30 and 38. They both died two days after receiving a second dose from a tainted batch of vaccines.
The third case was a 49-year-old man, who also fell ill after receiving his second dose, and died the next day, the health ministry said, noting that his only known health issue was a buckwheat allergy.