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Audenz FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 24, 2020.

FDA Approved: Yes (First approved January 31, 2020)
Brand name: Audenz
Generic name: influenza A (H5N1) monovalent vaccine, adjuvanted
Dosage form: Injection
Company: Seqirus
Treatment for: Influenza Prophylaxis

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) is a cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.

  • An influenza pandemic is a global epidemic caused by the emergence of a new influenza virus to which there is little or no pre-existing immunity in the human population.
  • Audenz is approved for use in persons 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
  • Audenz combines two leading-edge technologies - MF59® adjuvant and cell-based antigen manufacturing. The adjuvant reduces the amount of antigen required to produce an immune response, increasing the number of doses of the vaccine developed so that a large number of people can be protected as quickly as possible.
  • Audenz is a two-dose immunization series. The two doses are administered via intramuscular injection 21 days apart.
  • Common side effects include injection site pain, fatigue, headache, malaise, joint and muscle pain, and nausea. Hypersensitivity reactions can occur and appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of the vaccine.

Development timeline for Audenz

Feb  3, 2020Approval FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine

Further information

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