Replies

yes.

“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 antibiotics.

AUDENZ 0.5 mL single-dose pre-filled syringes contain no preservative.

AUDENZ 5 mL multi-dose vials contain thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury.

The tip caps and plungers of the pre-filled syringes and the multi-dose vial stopper are not made with natural rubber latex.”

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