GlaxoSmithKline ($GSK), which is already dealing with manufacturing issues at an influenza vaccine plant in Canada, acknowledged that "human error" at a polio vaccine plant in Belgium created a situation that it has been sorting out with regulators there.
GSK acknowledged a report by the European Centre for Disease Prevention and Control that 45 liters "of liquid contaminated with poliovirus were released from the GSK Rixensart site into the local sewage treatment plant of Rosières and subsequently into the Lasne River." A spokesman explained in an email that the incident involved "an accidental discharge of cleaning solution that had been used to sanitize equipment used in the manufacture of polio vaccine."
It said that it agreed with Belgian authorities that the chance of anyone developing polio from being exposed to the water was very low, "given the high level of dilution and high level of public vaccination (vaccination against polio is compulsory in Belgium)." It said authorities had lifted a precautionary measure to avoid water activities in Lasne after samples taken from the treatment plant in Rosières, from the Lasne and the Dyle rivers on Sept. 6, four days after the incident, "were negative: 'no presence of poliovirus was detected.'"
"Our focus now is on cooperating fully with the Minister of Health and the Federal Agency for Medicines and Health Products to ensure that all necessary measures are put in place to prevent any similar incident occurring again."
GSK Vaccines is headquartered in Belgium. Earlier this year it warned that there would be a shortage of chickenpox vaccine and its combo vaccine for measles, mumps, rubella and varicella (chickenpox) in countries outside of the U.S. after some of it being manufactured in Belgium didn't meet standards. The problem resulted in it holding up the release of all varicella-containing vaccine while it investigated.
The most recent manufacturing mess-up in Belgium came the same week that GSK acknowledged new problems at its vaccine plant in Ste-Foy, Quebec, had again interrupted production and was affecting supply. The problem left it 2 million doses shy on its FluLaval trivalent vaccine commitment to Canada for the upcoming flu season. It said it was still assessing what effect it would have on its ability to supply the vaccine in the U.S. It was the latest in a series of problems at the plant.
- here's the ECDC report
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