New problems at GSK flu vaccine plant will impact U.S., Canada orders

GlaxoSmithKline's ($GSK) Canadian flu vaccine plant has been in the spotlight recently for problems that spurred an FDA warning letter and a talking-to from Health Canada. But it's different problems that the British drugmaker now says will keep it from filling about 30% of its Canadian order for this season--and they could compromise some of its U.S. shipments, too.

Issues at the company's Ste-Foy, Quebec facility will prevent it from delivering just less than 2 million doses to the Public Health Agency of Canada, company spokeswoman Michelle Smolenaars Hunter told FierceVaccines in an emailed statement.

With respect to U.S. supply, the delays "will impact the shipment of additional doses produced at this site," she said, although the company doesn't yet know the full effect they'll have on U.S. supply and delivery dates.

Specifically, GSK found irregular results within its quality control monitoring, which spurred a production suspension in August, as well as an invalid test result on one component of the trivalent vaccine, she said. Those issues follow a pair of regulatory wrist-slaps from the U.S. and Canada, with the FDA this summer citing ongoing bacteria problems at the plant.

Somlenaars Hunter said GSK is still aiming to provide at least 28 million flu-vaccine doses to the U.S. market this season despite the holdup at Ste-Foy, which was slated to churn out a good portion of that supply. And the company will need that projection to hold true if it hopes to follow up on last year's Q4, which saw a 76% sales boost thanks to Quebec-produced Fluarix Quadrivalent.

- get more from The Canadian Press
- see FiercePharmaManufacturing's take

Special Reports: The top 5 vaccine makers by 2013 revenue - GlaxoSmithKline | Major FDA vaccine approvals of 2012 - Fluarix Quadrivalent - FluLaval

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