GlaxoSmithKline's 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.
The PharmaJet injector delivers the vaccine by means of a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second.
GlaxoSmithKline's 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.
While GlaxoSmithKline is eyeing a strong performance from Fluarix Quadrivalent 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.
Last year's flu vaccine didn't provide as much coverage as scientists had hoped, and now researchers from Canada's British Columbia Centre for Disease Control think they have discovered the culprit.
After collaborating with the University of Michigan-spinout NanoBio over the past three years, Merck has signed off on a new licensing pact for the biotech's nanoemulsion adjuvant technology.
Strokes are associated with a well-known set of risk factors, yet these triggers only explain 60% of strokes. The causes of the rest--and reasons strokes peak in winter--are unclear, but a growing body of evidence suggests flu vaccines may help to prevent these cases.
Last summer the United Kingdom set primary care physicians the ambitious target of vaccinating 75% of high-risk patients against influenza. The short notice and scale of the goal--which represents a 50% increase in one winter--caused consternation among physicians who said it would take a miracle to achieve. Now it appears no miracle occurred and the U.K. will miss its target.
Infecting healthy volunteers with influenza in a controlled environment will allow researchers to track each step of the immune response, potentially revealing answers to some fundamental questions limiting the effectiveness of vaccines.
Strong demand for flu vaccines in Canada has left authorities scrambling for supplies this winter, but in general preventive vaccines have suffered less severe shortages than drugs in recent years. BIO argues this is evidence the current system for vaccines works and has asked the FDA to rethink its drug shortage plans.