Moderna recalls vaccine batch after foreign substance found in CDMO-made vial—again

The specter of particulates has forced another recall—this time on Moderna’s massively successful COVID-19 vaccine Spikevax—and the latest pull isn’t contract manufacturer Rovi’s first brush with contamination, either.

Moderna on Friday said it was recalling one Spikevax lot in Europe.

The batch contains 764,900 doses made by CDMO Rovi that were deployed across Norway, Poland, Portugal, Spain and Sweden between Jan. 13 and Jan. 14. Moderna yanked the shots because of a “foreign body” found in one vial of the batch made at Rovi’s site in Spain, the partners said in a release.

The suspect vial was punctured but not administered, the companies added. Moderna and Rovi learned about the contamination issue from a vaccination center in Málaga, Spain. The tainted vial was “returned for forensic assessment and investigation,” the companies noted.

Afterward, Moderna ran a search of its global safety database, finding that no safety concerns cropped up in people who received a Spikevax dose from the suspect batch.

The company says it’s performing the recall out of an “abundance of caution.” Moderna said it’s working closely with health authorities as it runs its investigation, adding that it and Rovi are “committed to working transparently and expeditiously with regulators to address any potential concerns.”

More than 900 million doses of its mRNA-based shot have been administered around the world so far, Moderna said. The company doesn’t think the problems with the solo vial pose a risk to others in the lot, nor does it believe the issue “affects the significant benefit/risk profile of the vaccine.”

The move follows a similar particulate brouhaha in Japan last year.

Back in August, Moderna confirmed over email that it received “several complaints of particulate matter” in vials of its vaccine there. The complaints stemmed from “one product lot” that was distributed in the country, a Moderna spokesperson told Fierce Pharma at the time.

Simultaneously, Kyodo News reported that Moderna’s Japanese vaccine partner, Takeda, had halted the use of 1.63 million Spikevax doses.

An investigation by Rovi ultimately concluded that the particulates found in the Japanese vials were stainless steel.

In October, Moderna, Rovi and Takeda announced that “human error” was the likely culprit behind the particulates’ presence. The manufacturing flub occurred at a Rovi plant in Spain, which released three vaccine lots after a fourth from the same production run failed an inspection. The fourth and fifth lots from the manufacturing series were held back, Moderna explained in a 16-page report.

The stainless-steel contaminants resulted from friction between two pieces of metal that had been incorrectly installed in the stopper module of the production line, the report continued.

Outside the realm of pandemic vaccines, particulate contamination has prompted scores of recalls in recent years.

Just a few weeks back, Teva Pharmaceutical recalled one lot of the injectable leukemia med IDArubicin hydrochloride after an internal inspection flagged silica and iron oxide particulate matter in a lone drug vial.

Earlier in March, meanwhile, Fresenius Kabi yanked seven lots of sodium acetate intravenous fluid in the U.S. because testing revealed particulates of carbon and oxygen with traces of sodium silicon, chromium, aluminum and cellulose.  

Particulates have also proven a major hang-up for Foster City, California-based Gilead Sciences. In December, the drugmaker said it was pulling two lots of the COVID-19 antiviral Veklury, also known as remdesivir, because a customer complaint flagged the presence of glass particulates, which Gilead then confirmed through its own investigation.

Separately, Gilead’s HIV prospect lenacapavir has been hit with clinical holds and even an FDA complete response letter on fears over the compatibility of the solution with the borosilicate vials it’s stored in.