Vaccine Info

Audenz Influenza A(H5N1) Vaccine

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Staff
Last reviewed
November 24, 2021
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Audenz Influenza A(H5N1) Vaccine Description

Seqirus Inc. Audenz is a monovalent, adjuvanted, cell-based inactivated influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1) in the event of an influenza pandemic. The initial U.S. FDA Approval was in January 2020.

Audenz combines Seqirus' proprietary MF59® adjuvant technology with its cell-based manufacturing platform. Influenza vaccines using the MF59 adjuvant may enhance and broaden the body's immune response by inducing antibodies against virus strains mutated.

An alternative to traditional egg-based manufacturing, cell-based manufacturing avoids egg-adapted changes, one source of strain mismatch between the vaccine and circulating pandemic influenza virus.

U.S. FDA STN: 125692; BLA Approval; Supplemental Approval Letter: BL125692/18; 

Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX: CSL). Trademark: 88789443.

Audenz Influenza A(H5N1) Vaccine Indication

An influenza pandemic occurs when a new flu virus emerges for which humans have little or no immunity, allowing the virus to spread rapidly from person to person worldwide. Influenza A(H5N1) is commonly known as Avian Flu.  Avian influenza A viruses usually do not infect people; however, rare cases of human infection have been reported. 

Audenz is indicated to protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic.

Audenz Influenza A(H5N1) Vaccine Dosage

Audenz is administered as an intramuscular injection. It is given in two doses, .5 ml each, 21 days apart.

Audenz Influenza A(H5N1) Vaccine Side Effects

In adults 18 through 64 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain (64%), fatigue (25%), headache (25%). History of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component or after a previous dose of an influenza vaccine.

Audenz Influenza A(H5N1) Vaccine News

November 23, 2021 - The FDA has approved multi-dose vial presentation for AUDENZ to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic.

October 4, 2021 - Seqirus that the Biomedical Advanced Research and Development Authority selected Seqirus to develop two influenza A(H2Nx) virus vaccine candidates for assessment in Phase 1 clinical study with the goal of helping to safeguard communities in the event of an influenza pandemic. The first candidate will utilize a combination of cell-based and adjuvanted technologies, building on Seqirus' highly flexible combination platform technology used by AUDENZ.

February 3, 2020 - Seqirus Announces U.S. FDA Approval of Its First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine.

January 31, 2020 - The FDA approves Seqirus' Biologics License Application for Influenza A (H5N1) Monovalent Vaccine, Adjuvanted effective for use in persons six months of age older. For use in persons six months through 17 years of age, the FDA has approved the BLA according to the regulations for accelerated approval, 21 CFR 601.41.

Audenz Influenza A(H5N1) Vaccine Clinical Trials

Audenz has been studied in various clinical trials.