FDA Approves Audenz as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine

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INDICATIONS AND USAGE

AUDENZTM is an inactivated 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 6 months of age and older at increased risk of exposure to the influenza A H5N1 virus subtype contained in the vaccine. Use in persons 6 months through 17 years of age is approved under accelerated approval based on the immune response elicited by AUDENZ. Effectiveness of the seasonal vaccine made by the same process has not been confirmed for this age group. Continued approval for use in this age group may be contingent upon verification and description of clinical benefit in confirmatory trials.

DOSAGE AND ADMINISTRATION

For intramuscular injection only

• Dose and Schedule

  • Administer two doses of AUDENZ (0.5 mL each), 21 days apart.

• Administration

  • Gently shake the syringe. AUDENZ has a milky-white appearance. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. If either condition exists, AUDENZ should not be administered.

  • The vaccine should be administered by intramuscular injection. Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk. For those over 12 months of age, the preferred injection site is the region of the deltoid muscle of the upper arm; for those 6 months through 11 months of age, the preferred injection site is the anterolateral thigh.

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DOSAGE FORMS AND STRENGTHS

AUDENZ is an injectable emulsion for intramuscular use. Each dose (0.5 mL) is supplied in a prefilled single-dose syringe.

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CONTRAINDICATIONS

Do not administer AUDENZ to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of an influenza vaccine.

AUDENZ, a sterile injectable emulsion for intramuscular use, is an inactivated, monovalent, subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells, a continuous cell line. These cells were adapted to grow freely in suspension in culture medium. The virus is inactivated with ß-propiolactone, disrupted by the detergent cetyltrimethylammonium bromide and purified through several process steps. The influenza antigen contained in AUDENZ is manufactured according to the same process as that used to produce the antigens contained in FLUCELVAX® and FLUCELVAX® QUADRIVALENT, which are unadjuvanted seasonal influenza vaccines licensed for use in the United States.

AUDENZ is a milky-white emulsion. Each 0.5 mL dose is formulated to contain 7.5 mcg of hemagglutinin (HA) of the influenza virus strain A/turkey/Turkey/1/2005 NIBRG-23, a reverse genetics-derived reference strain supplied by the National Institute for Biological Standards and Control (NIBSC), and MF59C.1 adjuvant (MF59), a squalene-based oil-in-water emulsion (9.75 mg squalene, 1.175 mg polysorbate 80, 1.175 mg sorbitan trioleate, 0.66 mg sodium citrate dihydrate and 0.04 mg citric acid monohydrate), at pH 6.5-7.7.

Each dose of AUDENZ may also contain residual amounts of protein other than HA (≤ 30 mcg) including MDCK cell protein (<3.15 mcg), MDCK cell DNA (≤ 10 ng), additional polysorbate 80 (≤ 0.375 mg), cetyltrimethylammonium bromide (≤ 4.5 mcg), and ß-propiolactone (≤ 0.1 mcg), which are used in the manufacturing process. AUDENZ contains no preservative or antibiotics. The syringe components (tip caps, syringe, syringe plunger/stopper) are not made with natural rubber latex.