GlaxoSmithKline plc (GSK) announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine candidate supports its licensure for the active immunisation for the prevention of disease in persons 18 years of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
“GSK has been collaborating with the U.S. Department of Health and Human Services since 2006 to develop this H5N1 vaccine and we are pleased with the positive vote recommending its approval” commented Bruce Innis, Vice President, GSK Global Vaccines Discovery and Development. “We now look forward to a final decision by the FDA later this year and to also continuing our collaboration with the U.S. Government on public health issues.”
The VRPAC provides the FDA with independent expert advice and non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. According to agency regulations, the FDA is scheduled to conclude its review for the vaccine in December 2012. If approved, the vaccine is to be used only according to official guidance from the U.S. Government.
Date: November 14, 2012
Source: GlaxoSmithKline plc