Moderna and Rovi pharmaceuticals have issued a recall of more than 750,000 doses of Spikevax, which is Moderna’s COVID-19 shot due to contamination. This lot had been supplied to the Europe countries of Spain, Poland, Norway, Portugal, and Sweden in mid-january.
The company clarified that the contaminated vaccine dose had not been administered to people and was punctured. The two partners became aware of the contamination after a complaint was received from a Spanish vaccination center located in Málaga.
Moderna representative stated that the vial containing the foreign body had been returned to the company and was being investigated by their team.
The vial was produced in Rovi’s contracted Spanish manufacturing facility.
The complaint for contamination triggered a search across Moderna’s global safety database for any issues reported due to the vaccinations administered from this lot. No such problem cases were found by Moderna in terms of safety or efficacy.
With over 900M of Moderna’s COVID-19 doses administered across the globe, Moderna stated that this contamination in the reported vial does not impact the vaccine doses’ efficacy or safety in other lots. Other lots are not at risk for this contamination.
Rovi Pharma stated that due to the company’s priority to quality and practicing of strong caution, they had decided to recall the entire lot of the contaminated vial belongs to. Furthermore, Moderna is fully working with the relevant health and regulatory authorities in the investigation.
The company stated that the recall is being conducted due to an “abundance of caution.” and that both Moderna as well as Rovi Pharma are “committed to working transparently and expeditiously with regulators to address any potential concerns.”
However this is not the first time Moderna has been plagued by contamination of a foreign body in its vaccine vials. Last year in Japan a similar situation arose when Moderna received complaints of a foreign matter in vaccine vials, which was traced back to one lot.
After investigation by Rovi, the foreign body in the vials was identified as stainless steel particles, which Moderna and Rovi explained was the probable result of human error.
Moderna had reported at that time that these foreign particles came to be found in the vaccine vials through an incorrectly installed machinery on the production line, which, through friction between metal pieces, caused the stainless steel to be present.
Last month Moderna and the Japanese Ministry of Health signed an agreement for Moderna’s booster dose supply to increase by 70 million doses.
Similarly, Gilead Sciences’ COVID-19 antiviral drug Veklury was reported to be contaminated by glass particles which was found after a customer complaint, and was confirmed by the company itself after conducting an investigation.
Contamination in the pharmaceutical sector has not been limited to COVID-19 vaccines or Moderna. Some other examples of contamination and recall include Teva Pharma’s IDArubicin hydrochloride and Fresenius Kabi’s sodium acetate fluid.
Teva Pharma’s IDArubicin hydrochloride was found to include silica and iron oxide particles in a vial of the leukemia drug. Fresenius Kabi’s sodium acetate solution had been found to contain traces of chromium, aluminum, cellulose and sodium silicon.