US FDA approves GSK’s bird flu vaccine

The US Food and Drug Administration has approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu, which is manufactured by a subsidiary of the global pharma company, GSK.

The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus.

Most avian influenza A viruses do not infect people, however some, such as H5N1, have caused serious illness and death in people outside of the US, mostly among people who have been in close contact with infected and ill poultry. According to the WHO, when people become infected with H5N1, about 60% die.

"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. Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic."

Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research.

"Supporting the U.S. Government's capability to help protect Americans against pandemics ranks among GSK's most important U.S. public-health responsibilities. H5N1-related illness has thus far been rare, but life-threatening when it has occurred. GSK scientists approached this clinical development project driven by the recognition that the resulting vaccine might be needed in the future to help protect millions of Americans against pandemic flu illness."

Bruce Innis, Vice President of Vaccines Development for GSK.

The US Department of Health and Human Services has purchased the vaccine from the manufacturer, ID Biomedical Corporation of Quebec, Quebec City, Canada (a subsidiary of GlaxoSmithKline Biologicals), for inclusion within the National Stockpile for distribution by public health officials if needed.