US committee recommends approval of GSK’s bird flu vaccine

A US health regulator has recommended the approval of GlaxoSmithKline's new bird flu vaccine.

A US health regulator has recommended the approval of GlaxoSmithKline's new bird flu vaccine.

The US FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously that the H5N1 adjuvanted influenza vaccine is safe for use in adults who are at increased risk of exposure to the virus.

GSK has been collaborating with the US Department of Health and Human Services since 2006 to develop the vaccine.

GSK Global Vaccines Discovery and Development vice president Bruce Innis said; "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 US Government on public health issues."

The FDA is scheduled to conclude its review for the vaccine in December 2012.

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 general adverse events were injection site pain and swelling, muscle aches, headache, fatigue, joint pain, shivering and sweating.

Image: GSK has collaborated with the US Department of Health to develop the vaccine since 2006. Photo: Courtesy of GSK.