FDA clears first H5N1 vaccine: First step in pandemic preparedness

The US Food and Drug Administration (FDA) today approved the first adjuvanted vaccine against H5N1 influenza, a product destined for the US government’s pandemic emergency stockpile.

It is also the nation’s first adjuvanted flu vaccine to gain FDA clearance.

The vaccine, made by a Canadian subsidiary of GlaxoSmithKline (GSK), is indicated for use in people age 18 and older who are at increased risk of exposure to H5N1 avian influenza, the FDA said in a statement.

Dose-sparing strategy

An adjuvanted vaccine is designed to produce a stronger immune response with less antigen, a dose-sparing strategy that would allow health officials to stretch the supply of antigen, the “active ingredient” in vaccines. Such a dose-sparing approach would be especially important in a pandemic setting.

The vaccine contains 3.75 micrograms (mcg) of antigen, compared with 15 mcg in standard flu vaccines. In previous years, the US government has acquired a supply of adjuvants for possible emergency use, but they weren’t part of a specific vaccine.

Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement, “This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe.”



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