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12:00 AM
 | 
Dec 03, 2012
 |  BioCentury  |  Regulation

Pandemic pathways

GSK's adjuvanted influenza vaccine threads novel regulatory needle in U.S.

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.

Indeed, the Q-Pan BLA relied in part on data collected in countries outside the U.S. that approved the vaccine and similar products earlier.

Obtaining approval and safety data outside the U.S. before approaching FDA could emerge as a feasible strategy for companies seeking to market adjuvanted vaccines in the U.S., Ronald Ellis, SVP of R&D and CTO of NasVax Ltd., told BioCentury. "This may be especially useful when the adjuvant is novel," he said.

Ellis is also editor-in-chief of the journal Human Vaccines & Immunotherapeutics.

Under the EMA procedure, a company develops a mock-up vaccine based on a strain of influenza virus that could potentially cause a pandemic but is not currently in circulation in humans and to which few individuals have been exposed. If the mock-up vaccine meets safety and immunogenicity criteria in humans, it is eligible for approval under EMA's "exceptional circumstances" provision.

When a pandemic outbreak occurs, the viral strain in the mock-up vaccine is replaced with the actual pandemic strain,...

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