Flu Vaccine Ingredients & Package Inserts for FDA-Approved Vaccines in USA (2011-2012)

Image: David Dees

**UPDATE (September 23, 2012)** - For a list of the ingredients in the approved 2012-2013 flu vaccines, please see my blog post entitled REMIXX WORLD!: Flu Vaccine Ingredients & Package Inserts for FDA-Approved Vaccines in the United States of America (2012-2013)

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I recently posted a photo in another blog post and briefly discussed the 2011 flu vaccine. Suddenly, I was getting Google hits, so I guess people are still interested in the flu vaccine ingredients. I thought I beat that horse to death back in 2009-10, but I guess not. Therefore, below are five (5) flu vaccines approved for use in the United States of America.

Please note that this 2011 flu vaccine will contain a vaccine for the H1N1 "swine flu" as well. You can read my 2009 and 2010 analysis on the H1N1 vaccine by clicking here.

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1. FLUZONE® by Sanofi Pasteur (FDA link)

Here is the package insert information from one such 2011 flu vaccine called Fluzone® by Sanofi Pasteur.

Depending on the specific vaccine that you may get, Fluzone can potentially include any of the following ingredients:

• Formaldehyde
• Gelatin
• Octylphenol Ethoxylate - an emulsifier
• Thimerosal (a mercury derivative) (in the 0.5 mL multi-dose)

For a table of the ingredients, click here and here.

2. FLUVIRIN® by Novartis (FDA link)

For the official package insert for this vaccine, here it is courtesy of Novartis. The ingredients are listed on in Section 11 on page 20, but I will quote it here for you. Please note that multidose of the vaccine may also contain betapropiolactone and according the CDC website, betapropiolactone is a potential carcinogen. The multidose also contains nonylphenol ethoxylate which is used in detergents.

FLUVIRIN® is a trivalent, sub-unit (purified surface antigen) influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with a specific type of influenza virus suspension containing neomycin and polymyxin. Each of the influenza virus strains is harvested and clarified separately by centrifugation and filtration prior to inactivation with betapropiolactone. The inactivated virus is concentrated and purified by zonal centrifugation. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of nonylphenol ethoxylate, a process which removes most of the internal proteins. The nonylphenol ethoxylate is removed from the surface antigen preparation.FLUVIRIN® is a homogenized, sterile, slightly opalescent suspension in a phosphate buffered saline. FLUVIRIN® has been standardized according to USPHS requirements for the 2010-2011 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following 3 viruses: A/California/7/2009, NYMC X-181 (H1N1); A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus); and B/Brisbane/60/2008.The 0.5-mL prefilled syringe presentation is formulated without preservative. However, 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 tip caps of the FLUVIRIN® prefilled syringes may contain natural rubber latex. The multidose vial stopper and the syringe stopper/plunger do not contain latex.

3. FluMist by MedImmune, LLC (FDA link)

As always with the intranasal vaccines, this one has live viruses, including H1N1 and H3N2! Please make note of that information if/when you select a particular vaccine (or not). You can find the specific ingredients on page 3 in section 11, but the ones to notes are MSG and porcine gelatin (processed pigskins).

Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU of live attenuated influenza virus reassortants of each of the three strains: A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. 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, 13.68mg/dose sucrose, 2.26mg/dose dibasic potassiumphosphate, 0.96mg/dosemonobasic potassium phosphate, and 0.015 mcg/mL gentamicin sulfate. FluMist contains no preservatives.

4. FLULAVAL by GlaxoSmithKline (FDA link)

I've previously discussed FLULAVAL in the November 2009 blog posting FDA Approves GlaxoSmithKline's H1N1 "Swine Flu" FLULAVAL® Vaccine (Fifth Vaccine Maker in the USA). I don't know if it's the same ol' vaccine, different year, but let's find out. The ingredients are listed in Section 11, page 8. My major note is that this vaccine contains mercury!

FLULAVAL is a sterile, translucent to whitish opalescent suspension in a phosphate-buffered saline solution that may sediment slightly. The sediment resuspends upon shaking to form a homogeneous suspension. FLULAVAL has been standardized according to USPHS requirements for the 2011-2012 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/California/7/2009 NYMC X-181 (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008. 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.

5. FLUARIX by GlaxoSmithKline (FDA link)

Interesting that this vaccine contains a few different ingredients than the other vaccines, particularly stuff like octoxynol-10 (an emulsifier) and polysorbate 80.

FLUARIX has been standardized according to USPHS requirements for the 2011-2012 influenza season and is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5-mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/California/7/2009 NYMC X-181 (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008.FLUARIX is formulated without preservatives. FLUARIX does not contain thimerosal. Each 0.5-mL dose also contains octoxynol-10 (TRITON® X-100) ≤0.085 mg, α-tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg. Each dose may also contain residual amounts of hydrocortisone ≤0.0016 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process.