Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted is approved for “the active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine,” according to an FDA announcement. It is the first adjuvanted vaccine for prevention of H5N1 avian influenza.
The vaccine will not be commercially available, according to the FDA. The U.S. Department of Health and Human Services 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.
“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,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic.”