US FDA committee recommends GSK’s influenza vaccine for approval
The FDA advisory committee has voted in favour of GlaxoSmithKline’s H5N1 influenza vaccine candidate and recommends it for approval.
The US FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously 14-0 that the safety and immunogenicity data of GSK’s H5N1 adjuvant 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. 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”.
Bruce Innis, Vice President, GSK Global Vaccines Discovery and Development.
The FDA is expected to make its final decision on the influenza vaccine’s approval in December 2012. If approved, the vaccine is to be used only according to official guidance from the U.S. Government.
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