As Glaxo begins 2014-15 flu vaccine shipments, manufacturing questions linger

The first doses of GlaxoSmithKline's ($GSK) Fluarix Quadrivalent are on their way out to the public, with the company announcing Wednesday that shipping had begun. And while Glaxo's eyeing a strong performance from the shot in its sophomore year, it may have to rely on Fluarix more than it would like if it doesn't make peace with regulators over quality issues at its FluLaval plant.

The Fluarix Quadrivalent shipment will make up part of the 28 million to 33 million doses of four-strain and three-strain flu shots the pharma giant expects to provide for the U.S. for the 2014-2015 flu season, and GSK is hoping the product can follow up on the 76% sales jump it helped drive in last year's fourth quarter.

"Since introducing our own four-strain vaccines last year, we've seen a strong uptake," Deborah Waterhouse, Glaxo's U.S. vaccines head, said in a statement.

And the British drugmaker might need that strong uptake even more going forward. It's currently taking heat from regulators in both the U.S. and Canada for problems at its Ste-Foy, Quebec, plant, the home of manufacturing for another of its seasonal flu vaccines, FluLaval.

The troubled facility is slated to provide about 23 million of those 28 million to 33 million this year, a spokeswoman told The Canadian Press earlier this month. But this year alone, ongoing bacteria problems there have forced the company to toss out more than 20% of the lots it's produced.

Now, Health Canada has given Glaxo until Aug. 4 to pen a remediation proposal and timeline for whipping the plant into shape; in the U.S., regulators recently slapped the company with a warning letter, giving it 15 days to fix its plant issues or explain the delay and lay out detailed plans for getting things under control.

- read the release

Special Reports: Top 5 Vaccine Companies by Revenue - 2012 - GlaxoSmithKline | Major FDA vaccine approvals of 2012 - Fluarix Quadrivalent - FluLaval