AstraZeneca Plc. (AZN,AZN.L), Friday said its nasally administered vaccine, Fluenz Tetra, got Marketing Authorisation from the European Commission. Fluenz Tetra is a four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age. Through this approval, the vaccine becomes the only intra-nasal four-strain influenza vaccine available in Europe.
The marketing approval is based on a pivotal paediatric study data, in which Fluenz Tetra demonstrated a safety and immunogenicity profile that was comparable to Fluenz, a three-strain (trivalent) live attenuated influenza vaccine already approved in Europe. The European Commission decision comes after a positive Committee for Medicinal Products for Human Use opinion that was granted on September 19, applicable to all 28 member states and the three European Economic Area countries of the European Union.
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