Moderna is recalling 764,900 doses of its COVID-19 vaccine, Spikevax, made by contract manufacturer Rovi after discovering one of the vials was contaminated.
The faulty vial was reported and sent back to Moderna for testing before anything was administered to patients. There has been no news of safety issues. The report, from a center in Málaga, Spain, said the vial, which was contaminated with a “foreign substance” was punctured. Moderna did not release details on what was found in the vial.
According to Moderna, only one vial was affected but the drugmaker is recalling the whole lot out of “an abundance of caution” but does not think that the one contaminated vial will pose a threat to the others in the lot. The lot was distributed from January 13 to 14 in Norway, Poland, Portugal, Spain and Sweden. The doses were manufactured at Rovi’s facility in Spain.
Moderna inked the deal with Spain's Laboratorios Farmacéuticos Rovi for fill-finish duties on "hundreds of millions of does" back in 2020.
Despite Moderna’s heavyweight status in COVID-19 vaccine production, this is not its first brush with contamination.
In August, the company pulled 1.63 million doses of its COVID-19 vaccine out of circulation in Japan over concerns of contamination. Health officials reported that particulates a few millimeters in size were found in doses at multiple vaccination sites in Japan. The doses were also manufactured in Rovi's facility in Spain.
To date, more than 900 million doses of Moderna’s COVID-19 vaccine have been administered worldwide. In February, Spikevax became the second COVID-19 vaccine to receive full approval from the U.S. FDA, after Pfizer Comirnaty. Spikevax was first granted FDA approval for emergency use authorization in December 2020.
Moderna and Rovi will continue to work with regulators to address any potential concerns going forward, Rovi said.