General Information

Audenz is an adjuvanted, cell-based influenza vaccine.

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

Audenz is supplied as an injectable emulsion for intramuscular use. Administer two doses of Audenz (0.5 mL each), 21 days apart.

Mechanism of Action

Audenz combines Seqirus’ MF59 adjuvant and cell-based antigen manufacturing. The MF59 adjuvant is believed to enhance an immune response from the body by inducing antibodies against virus strains that have mutated. 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.

The vaccine is designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of pandemic.

Side Effects

Adverse effects associated with the use of Audenz may include, but are not limited to, the following:

• 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, fatigue headache, malaise, myalgia, arthralgia and nausea.
• In adults 65 years of age and older, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain, fatigue, malaise, headache and arthralgia. 
• In infants and children, 6 months through 5 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were tenderness, irritability, sleepiness, change in eating habits and fever.
• In children 6 through 17 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain, myalgia, fatigue, malaise, headache, loss of appetite, nausea and arthralgia.

Clinical Trial Results

Seqirus presented data at the Options for the Control of Influenza (OPTIONS X) Conference in Singapore in August of 2019. The data are from clinical studies demonstrating the ability of a MF59 adjuvanted influenza vaccine to increase immune responses when used in both seasonal and pandemic influenza vaccines, across pediatric and adult populations. In the pediatric Phase II study (V89_11), a total of 322 subjects aged 6 months through 17 years received full doses of a MF59 adjuvanted, cell-derived influenza A (H5N1) vaccine (aH5N1c) three weeks apart. In two separate but similar adult and elderly Phase II studies (V89_13; V89_04), a total of 975 subjects aged 18 to 64 years of age and 1,388 subjects 65 years of age and older were equally randomized to received two full or half doses of a MF59 adjuvanted, cell-derived influenza A (H5N1) vaccine (aH5N1c) three weeks apart. A full dose was 7.5 μg HA of H5N1 with 0.25 mL MF59 for a total injection volume of 0.5 mL, and a half-dose was 3.75 μg HA of H5N1 with 0.125 mL MF59 for a total injection volume of 0.25 mL.

Antibody responses against five pre-determined H5N1 clades were measured by hemagglutination inhibition (HI) and microneutralization (MN) assays in pre-defined exploratory analyses. Adult and elderly subjects that received the full dose demonstrated increased immunogenicity against heterologous A (H5N1) strains from five different clades. Pediatric subjects that received the full dose demonstrated increased immunogenicity against heterologous A (H5N1) strains.