EU Nod for AZ's Nasal Flu Vaccine For Children
The four-strain nasal vaccine Fluenz Tetra - known as Flumist Quadrivalent in the US - was given the regulatory nod of approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) last week and, if approved by the European Commission, is set to replace the firm’s trivalent vaccine, Fluenz.
The product “is a gentle mist administered through the nose and starts working in the nose where flu enters the body,” AstraZeneca spokesperson Vanessa Rhodes told in-Pharmatechnologist.com.
Furthermore, she continued, “FluMist Quadrivalent/Fluenz are the only approved nasal spray vaccines of its kind to prevent seasonal influenza.”
Though seasonal flu vaccines normally contain three-strains of influenza, Fluenza Tetra contains four live attenuated influenza virus strains and will replace the three-strained variation in 2014-5. The three-strained version was first approved in 2003 for people aged 5-49.
At the time of going to press AstraZeneca was unable to provide us with more information regarding Fluenz Tetra’ bioavailabilty and how it compares with an injectable equivalent.
However, many pharma firms are looking to alternatives to injections in order to increase patient compliance. Intranasal delivery route is one administration technique that can keep bioavailabilty high as delivering treatment directly from deep in the nose into the brain can circumvent the blood-brain barrier.
Faron Jordan, Head of Preclinical and Clinical Development at Critical Pharmaceuticals, said at the Global Pharmaceutical Contract Manufacturing (GPCM) Event in June that the nasal route is attractive, especially for biologics, due to having a large surface area, an excellent blood supply, a rapid onset and the avoidance of first pass metabolism.
Critical is just one of a number of firms looking to intranasal systems with its CriticalSorb technology platform. Avanir recently bought North American rights to OptiNose’s novel delivery system for $110m.