While Genzyme Corporation faces a probable consent decree for its Cerezyme and Fabrazyme production troubles, the FDA asked physicians to temporarily stop using a GlaxoSmithKline vaccine because of contamination with a porcine virus.

Genzyme's chairman Henri Termeer said in a March conference call, “We are truly advancing in the recovery of the Allston Landing plant,” even though the FDA plans to “take enforcement action to ensure that products manufactured at the plant are made in compliance with good manufacturing practice regulations.” The agency may also levy fines against the company. The Allston plant has failed regulatory inspections since 2008, and in June 2009 a virus contamination issue forced its temporary closure.

Meanwhile, GSK's oral Rotarix vaccine (for protecting infants against rotavirus) was found in March 2010 to be contaminated with traces of type-I porcine circovirus (PCV-1). This DNA virus infects pigs but is not infectious to humans. It appears to have come from cell cultures used to make the vaccine.

Independent researchers found the contaminant while testing a new way to screen vaccines for impurities. Although this issue doesn't pose a safety risk, an FDA official said it would be smart to “pause and try to determine what this virus was doing in the vaccine and how it got there.”

Pediatricians were advised to use Merck's RotaTeq rotavirus vaccine rather than GSK's product for the time being. A GSK spokesperson said the company “is now reviewing how best to replace, in a timely way, the cell bank and virus seeds used as base production material.” The vaccine is made at a plant in Belgium. Preliminary tests of GSK's inactivated polio vaccine, also made in cell culture, found no virus contamination.