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Vaccines, Blood & Biologics

Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients

The Description and Ingredients information on this page is excerpted from the package inserts for each of the licensed Influenza A (H1N1) 2009 Monovalent Vaccines. Click on the below "Package Insert" links to view the complete original documentation provided by each manufacturer.

INJECTIBLE VACCINES

CSL Limited
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg HA per 0.5 mL dose of influenza A/California/7/2009 (H1N1)v-like virus.

The single-dose formulation is preservative-free; thimerosal, a mercury derivative, is not used in the manufacturing process for this formulation. The multi-dose formulation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.

A single 0.5 mL dose of Influenza A (H1N1) 2009 Monovalent Vaccine contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone (< 25 nanograms).

The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial contain no latex.

Package Insert - CSL Limited Influenza A (H1N1) 2009 Monovalent Vaccine (PDF - 263KB)

ID Biomedical Corporation of Quebec

Influenza A (H1N1) 2009 Monovalent Vaccine is a monovalent, split-virion, inactivated influenza virus subtype A vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate.

Influenza A (H1N1) 2009 Monovalent Vaccine, for intramuscular injection, is a homogenized, sterile, colorless to slightly opalescent suspension in a phosphate-buffered saline solution formulated to contain 15 mcg hemagglutinin per 0.5-mL dose of the influenza A/California/7/2009 (H1N1)v-like virus. Thimerosal, a mercury derivative, is added as a preservative. Each dose contains 25 mcg mercury. Each dose may also contain residual amounts of egg proteins (≤1 mcg ovalbumin), formaldehyde (≤25 mcg), and sodium deoxycholate (≤50 mcg). Antibiotics are not used in the manufacture of this vaccine.

The vial stopper does not contain latex.

Package insert – ID Biomedical Corporation of Quebec Influenza A (H1N1) 2009 Monovalent Vaccine (PDF - 201KB)

Novartis Vaccines and Diagnostics Limited
Influenza A (H1N1) 2009 Monovalent Vaccine is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered saline.  Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) per 0.5-mL dose of the following virus strain: A/California/7/2009 (H1N1)v-like virus.

The 0.5-mL prefilled syringe presentation is formulated without preservative. Thimerosal, a mercury derivative used during manufacturing, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose).

The 5-mL multidose vial formulation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.

Each dose from the multidose vial or from the prefilled syringe may also contain residual amounts of egg proteins (≤ 1 mcg ovalbumin), polymyxin (≤ 3.75 mcg), neomycin (≤ 2.5 mcg), betapropiolactone (not more than 0.5 mcg) and nonylphenol ethoxylate (not more than 0.015% w/v).

The multidose vial stopper and the syringe stopper/plunger do not contain latex.

Package Insert - Novartis Vaccines and Diagnostics Limited Influenza A (H1N1) 2009 Monovalent Vaccine (PDF - 312KB)

Sanofi Pasteur, Inc.
Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like virus per 0.5 mL dose. Gelatin 0.05% is added as a stabilizer. Each 0.5 mL dose may contain residual amounts of formaldehyde (not more than 100 mcg), polyethylene glycol p-isooctylphenyl ether (not more than 0.02%), and sucrose (not more than 2.0%).

There is no thimerosal used in the manufacturing process of the single-dose presentations of Influenza A (H1N1) 2009 Monovalent Vaccine. The multi-dose presentation of Influenza A (H1N1) 2009 Monovalent Vaccine contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose of the multidose presentation contains 25 mcg mercury.

Antibiotics are not used in the manufacture of Influenza A (H1N1) 2009 Monovalent Vaccine.

All presentations of Influenza A (H1N1) 2009 Monovalent Vaccine do not contain latex.

Package Insert - Sanofi Pasteur, Inc Influenza A (H1N1) 2009 Monovalent Vaccine (PDF - 228KB)

INTRANASAL (NASAL SPRAY)

MedImmune LLC
Each pre-filled refrigerated Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU of the live attenuated influenza virus reassortant of the pandemic (H1N1) 2009 virus: A/California/7/2009 (H1N1)v. Each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium phosphate, 0.96 mg/dose monobasic potassium phosphate, and <0.015 mcg/mL gentamicin sulfate. The vaccine contains no preservatives.

Package Insert - MedImmune LLC Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal (PDF - 226KB)

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448

Page Last Updated: 09/25/2013
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