) intranasal influenza vaccine, Fluenz Tetra has received
approval from the European Commission (EC). The vaccine is
approved for the prevention of influenza in children and
adolescents aged between 24 months and 18 years. The approval
marks the first nasally administered four-strain influenza
vaccine approval in Europe.
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Fluenz Tetra contains two strains of influenza A and two strains
of influenza B, which will provide an edge over currently
marketed trivalent vaccine, Fluenz. Fluenz Tetra will be
available from the 2014-2015 flu season in place of Fluenz.
The EC approved Fluenz Tetra based on encouraging data from a
pivotal pediatric study. The safety and immunogenicity profile of
Fluenz Tetra was found to be comparable to that of Fluenz in the
The Fluenz Tetra EU approval was not surprising considering that,
in Sep 2013, the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) had a rendered a positive
opinion on the approval of Fluenz Tetra.
We note that Fluenz Tetra is already marketed in the U.S. under
the trade name FluMist Quadrivalent (influenza vaccine live,
intra nasal). The U.S. Food and Drug Administration (FDA) had
approved FluMist Quadrivalent in Feb 2012.
Currently approved quadrivalent influenza vaccines include
) Flulaval Quadrivalent and
) quadrivalent formulation of Fluzone. While Flulaval
Quadrivalent is an intramuscular vaccine, Fluzone has an
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