H5N1 vaccine
A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.
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Vaccines have been formulated against several of the avian H5N1 influenza varieties. Vaccination of poultry against the H5N1 epizootic is widespread in certain countries. Some vaccines also exist for use in humans, and others are in testing, but none have been made available to civilian populations, however production could be scaled up to quantities sufficient to protect much of the Earth's population in the event of an H5N1 pandemic.
In January 2020, the U.S. Food and Drug Administration (FDA) approved Audenz, an adjuvanted influenza A (H5N1) monovalent vaccine. Audenz is a vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. Audenz is approved for use in persons six months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
Some older, egg-based H5N1 vaccines for humans that have been licensed are:
- Sanofi Pasteur's vaccine approved by the United States in April 2007,
- GlaxoSmithKline's vaccine Prepandrix approved by the European Union in May 2008, with reactive AS03 (containing squalene) adjuvant, and
- CSL Limited's vaccine Panvax approved by Australia in June 2008.
Other licensed H5N1 vaccines include:
- Adjupanrix, approved for medical use in the European Union in October 2009. Adjupanrix contains the flu strain A/VietNam/1194/2004 NIBRG 14 (H5N1).
- Foclivia, approved for medical use in the European Union in October 2009. Foclivia contains the flu strain A/Vietnam/1194/2004 (H5N1).
- Aflunov, approved for medical use in the European Union in November 2010. Aflunov contains the flu strain A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1).
- Pumarix, approved for medical use in the European Union in March 2011.
In November 2013, the U.S. Food and Drug Administration (FDA) approved an experimental H5N1 bird flu vaccine to be held in stockpiles. In a clinical trial including 3,400 adults, 91% of people age 18-64 and 74% of people age 65 or older formed an immune response sufficient to provide protection. Reported adverse effects were generally mild, with pain at the injection site being the most common adverse effect.