If FDA follows the recommendation of its Vaccines and Related Biological Products Advisory Committee, GlaxoSmithKline plc's Q-Pan H5N1 influenza vaccine could become the first product approved under novel regulatory pathways the agency has laid down for pandemic vaccines.

However, the U.S. still would be years behind Europe, which in 2009 approved its first two pandemic vaccines - GSK's Pandemrix H1N1 and Novartis AG's Focetria H1N1 - under a "mock-up procedure" instituted in 2004.