This article is more than 5 years old. Information may no longer be current.
FDA approves adjuvanted vaccine for H5N1 influenza
Click Here to Manage Email Alerts
The FDA today approved the first adjuvanted vaccine for the prevention of H5N1 avian influenza.
“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,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic.”
Karen Midthun
The vaccine is intended for use in individuals aged 18 years and older who are at increased risk for exposure to influenza A.
Adjuvanted — a virus monovalent vaccine developed through an egg-based manufacturing process — contains adjuvant AS03, an oil-in-water emulsion. The H5N1 component and the AS03 adjuvant are combined prior to use and administered via intramuscular injection in two doses separated by 21 days.
The approval was based in part on results of a multi-center trial which compared the safety and efficacy of the vaccine in 3,400 adults aged 18 years and older. The study also included 1,100 adults assigned to placebo.
Among 2,000 evaluable participants, 91% of those aged 18 to 64 years and 74% of those aged 65 years and older who received the two-dose regimen developed a level of antibodies expected to reduce the risk for influenza.
Injection site pain was the most common side effect in participants assigned to receive the vaccine. Other common adverse events included muscle aches, headache, fatigue and injection site redness and swelling.
The U.S. Department of Health and Human Services has purchased the vaccine from the manufacturer, ID Biomedical Corporation of Quebec. It is not commercially available.