The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has 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.
“GlaxoSmithKline (GSK) has been collaborating with the US 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 US 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 US Government.
The H5N1 influenza vaccine candidate, manufactured in Québec, is a two-component vaccine consisting of a monovalent, inactivated, split A/H5N1 influenza virus antigen and the AS03 adjuvant system. In clinical trials, the most common solicited local reactions and general adverse events were injection site pain and swelling, muscle aches, headache, fatigue, joint pain, shivering and sweating. The regulatory filing was previously announced in March 2012.GSK’s H5N1 influenza vaccine manufactured in Québec is currently approved in Europe under the brand name, Pumarix.
The H5N1 influenza vaccine programme was supported by a development contract (HHSO100200700029C) with the Biomedical Advanced Development and Research Authority (BARDA) of the US Department of Health and Human Services.