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.
Sanofi appealed to the FDA to change the labeling of its high-dose Fluzone vaccine to reflect superior efficacy data in people aged over 65, and now it has fresh trial results to back up its case that Fluzone High-Dose provides better protection in individuals in this age group compared to traditional flu jabs.
GlaxoSmithKline has submitted its plans to whip its troubled Quebec flu vaccine plant into shape to Health Canada, and the regulator says the action outline is up to snuff.
Scientists thought they may have been on to something as far as deciphering the link between GlaxoSmithKline's pandemic swine flu vaccine and narcolepsy. But now, unable to replicate their findings, they've retracted the study.
Thanks to supply limitations in the U.S. that spurred a near-30% drop in adult booster vaccines, Sanofi reported Q2 vaccines sales down 0.4% overall. But its flu business posted big gains, ballooning 18.9% to €59 million ($78.9 million)--and CEO Chris Viehbacher says he expects that trend to continue.
GlaxoSmithKline is in the process of reviewing regulatory results from a June inspection that found that 10 areas of its Ste. Foy, Quebec, vaccine manufacturing plant needed improvements. But in the meantime, Health Canada has imposed a condition on the facility's license, requiring notice before Glaxo resumes production of Fluviral and FluLaval Tetra.
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 month, the FDA chided GlaxoSmithKline over issues at its Canadian flu vaccine plant, home to production of seasonal product FluLaval. Now, it's got another regulator on its case, too: Health Canada wants to see GlaxoSmithKline lay out plans for correcting problems at the facility, and it's giving the company 30 days to do it.
Novartis has started shipping vaccines for customers in the U.S. in advance of the next flu season, which doesn't include a quadrivalent offering like many of its competitors. But the shipments will include Flucelvax, which now has an FDA-licensed American plant that's poised for production whenever flu shots are needed.
AstraZeneca's flu vaccine sales may have just gotten a boost, courtesy of federal regulators. Wednesday, they recommended that healthy children 2 to 8 years old receive the company's nasal spray flu vaccine FluMist in lieu of flu shots when available.