Influenza Vaccine

Biologics license application submitted to U.S. FDA for CAIV-T

Published in Medical Letter on the CDC and FDA, October 23rd, 2005

MedImmune, Inc., (MEDI) announced that it submitted a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) for approval to use cold adapted influenza vaccine, trivalent (CAIV-T) in preventing influenza in healthy individuals 5 to 49 years of age.

CAIV-T is MedImmune's investigational, refrigerator-stable formulation of FluMist (influenza vaccine live, intranasal), a frozen vaccine approved to prevent influenza in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. Included in the sBLA are data from a recently completed pivotal phase 3 study comparing the immunogenicity of...

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Source: Medical Letter on the CDC and FDA (2005-10-23)

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