Another lot of Moderna's Rovi-made Spikevax recalled after particulate found in vial
Another lot of Moderna’s Covid-19 vaccine, Spikevax, has been recalled in Europe after a foreign item was found in a vial manufactured at the Spanish CDMO Rovi.
Moderna was alerted of the problem through a vaccination center in Malaga, Spain, the biotech said. The vial was returned to Moderna for inspection, punctured and not administered. There were 764,900 doses in the lot, distributed throughout Norway, Poland, Portugal, Spain and Sweden on January 13 and 14. This is the second time a lot of Spikevax from Rovi has been recalled.
“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,” a statement from the company said. “To date, no safety or efficacy issues have been identified.”
Moderna doesn’t believe that this risk should affect other vials in the lot, nor should it affect other lots. Those who do come across an affected vial should contact 000190AAction@modernatx.com.
Back in July 2021, contamination was noted in a Rovi batch, Reuters reported, but supplies were shipped to Japan anyway. Three batches were then suspended when stainless steel was found in 39 vials of those three lots. A fourth and fifth lot failed inspection and were held back by Rovi.
Three men died in the fall of 2021, just days after receiving the second dose of their shot, which was a part of the three lots that will be recalled. The cause of death is being investigated right now.
“Given the company’s priority to assure quality, and out of an abundance of caution, this lot is being recalled,” the statement said. “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.”