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IND Clearance for Stem Cell Flu Vaccine

French biotech firm Vivalis (VLS.PA) and British partner GlaxoSmithKline (GSK.L) have US FDA  clearance to begin testing on humans for the first time flu vaccines which were produced using Vivalis’s technology.

  • The US FDA accepted an investigational new drug application that will allow GSK to test on humans in an early-stage Phase I trial its influenza vaccine produced using Vivalis’s EB66 duck stem cell technology.

It is the first time that Vivalis’ technology, which is quicker, simpler and cleaner than developing vaccines in chicken eggs, has been put through regulatory screening. 

  • Vivalis has said the flu vaccine could be the first EB66-based human vaccine to be marketed in 2015.