Canada says GSK flu vaccine plant is on track; the FDA remains mum

GlaxoSmithKline's ($GSK) plan of action for its troubled Quebec flu vaccine has gotten the thumbs-up from regulator Health Canada, but that is only a part of the puzzle for meeting its contracts to produce tens of millions of doses of four-strain and three-strain seasonal flu shots for the impending season. It still has to meet FDA demands. Health Canada took a look at the plant after the FDA sent GSK subsidiary ID Biomedical a warning letter for the plant in June, pointing out lots of concerns about contamination of flu vaccines. GSK has said it is working with both regulators. Canada, which gets more than half of its seasonal flu vaccines from the facility, says the drugmaker is on the right track. The FDA has been silent on the subject since issuing its warning letter, but GSK has acknowledged that the facility is on tap to produce a significant portion of the 28 million to 33 million doses of four-strain and three-strain seasonal flu shots that U.S. providers expect from it. Story | More