the novavax platform has been in various phase II in the form of a few different seasonal formulations and as a pandemic formulation.
I think there are "combined" safety data on about a thousand people from these dose ranging studies. Glaxo uses the vlp backbone for it's HPV vaccine that has been in more than 30,0000 women and is approved in austrailia, phillipines and the european union.
Once they have an AH1N1 vlp in bulk I think they will be permitted to go straight to a large trial, just like the egg grown vaccine is different every year, so every year the seasonal egg vaccine needs initial testing.
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