FRIDAY, JUNE 22, 2018

FDA approves first adjuvanted H5N1 vaccine

The U.S. Food and Drug Administration announced on Friday that it approved the first adjuvanted vaccine against H5N1 influenza infection for persons 18 years of age and older who are at high risk of infection.

The H5N1 influenza virus is considered to have pandemic potential because it could cause an epidemic if it developed sustained human-to-human transmission, since most people have no immunity to the virus. There is a 60 percent death rate among those infected with H5N1, according to the World Health Organization.

The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, was developed by Biomedical Corporation of Quebec, Quebec City, Canada, a subsidiary of GlaxoSmithKline Biologicals.

In clinical trials, 91 percent of individuals between 18 and 64 years old developed significant antibodies after receiving the vaccine. The vaccine is included in the national U.S. stockpile to be used in the event of an outbreak.

"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," Director of the FDA's Center for Biologics Evaluation and Research Karen Midthun said. "Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic."