The contaminated lot was manufactured at a contract manufacturing site, ROVI, in Spain, and was distributed in mid-January 2022 in Norway, Poland, Portugal, Sweden and Spain, according to a company press release.
Safety concerns have not been reported in those who received a vaccine from the contaminated lot, Moderna stated, adding that to date “no safety or efficacy issues have been identified.”
The company stressed that more than 900 million doses of its COVID-19 vaccine have been administered so far. The company said it believes the “foreign body” does not pose a “risk to other vials in the lot” or affect the benefits or risks of the vaccine.
“Given the Company’s priority to assure quality, and out of an abundance of caution, this lot is being recalled,” the company stated.
“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,” the pharmaceutical company stated.
Japan suspended the use of more than 1.6 million Moderna COVID vaccines in August after the country’s health ministry reported discovering “foreign materials” in at least 390 doses of the vaccine, The Epoch Times reported.