File photoI am receiving hits about H1N1 and other flu vaccines again. It seems like the traffic spikes around every August or so in connection with this topic. Therefore, I will post the 2012-2013 flu vaccine information! Please see below for the six (6) flu vaccines that are approved for use in the United States of America.
Please note that this 2012-2013 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. AFLURIA (FDA link)
The FDA Approval Letter for AFLURIA by CSL Biotherapies.
Here is the package insert information from one such 2012 flu vaccine called AFLURIA by CSL Limited.
AFLURIA, Influenza Virus Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.
AFLURIA is standardized according to USPHS requirements for the 2012-2013 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2012-2013 Northern Hemisphere influenza season: A/California/7/2009 (H1N1), NYMC X-181, A/Victoria/361/2011 (H3N2), IVR-165, and B/Hubei-Wujiagang/158/2009, NYMC BX-39 (a B/Wisconsin/1/2010-like strain).
Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; therefore these products contain no preservative. The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.
A single 0.5 mL dose of AFLURIA 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 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate ( ≤ 3 nanograms [ng]), polymyxin B (≤ 0.5 ng), and beta-propiolactone (≤ 2 ng).
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.
2. FLUARIX (FDA link)
The FDA Approval Letter for Fluarix by GlaxoSmithKline.
Here is the package insert and the ingredients information for the Fluarix vaccine are below.
FLUARIX, Influenza Virus Vaccine, for intramuscular injection, is a sterile colorless and slightly opalescent suspension. FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus solutions.
FLUARIX has been standardized according to USPHS requirements for the 2012-2013 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/Christchurch/16/2010 NIB-74XP (H1N1) (an A/California/7/2009-like virus), A/Victoria/361/2011 IVR-165 (H3N2), and B/Hubei-Wujiagang/158/2009 NYMC BX-39 (a B/Wisconsin/1/2010-like virus).
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.
The tip caps of the prefilled syringes may contain natural rubber latex. The rubber plungers do not contain latex.
3. FLULAVAL (FDA link)
The FDA Approval Letter for FluLaval by ID Biomedical Corporation.
FLULAVAL, Influenza Virus Vaccine, for intramuscular injection, is a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs. Each of the influenza virus strains is produced and purified separately. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate.
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 2012-2013 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-179A (H1N1), A/Victoria/361/2011 IVR-165 (H3N2), and B/Hubei-Wujiagang/158/2009 NYMC BX-39 (a B/Wisconsin/1/2010-like virus).Thimerosal, a mercury derivative, is added as a preservative. Each 0.5-mL dose contains 50 mcg thimerosal (<25 mcg mercury). Each 0.5-mL dose may also contain residual amounts of ovalbumin (≤0.3 mcg), formaldehyde (≤25 mcg), and sodium deoxycholate (≤50 mcg) from the manufacturing process. Antibiotics are not used in the manufacture of this vaccine. The vial stopper does not contain latex.
4. FluMist (FDA link)
The FDA Approval Letter for FluMist by MedImmune Vaccines, Inc.
I never had heard about porcine gelatin until I started writing these vaccine ingredients articles a few years back. Porcine gelatin is essentially processed pigskins. I'll quote some of the process here in case you don't have time to click the link. Also if anyone's religion or background prohibits any consumption or ingestion of pig or pork products, then please check to see if this porcine (a/k/a pig or pork) gelatin ingredient in the vaccine is permitted.
5. Fluvirin (FDA link)The FDA Approval Letter for FluMist by MedImmune Vaccines, Inc.
FluMist (Influenza Vaccine Live, Intranasal) is a live trivalent vaccine for administration by intranasal spray. FluMist contains three vaccine virus strains: an A/H1N1 strain, an A/H3N2 strain and one B strain...
Each pre-filled refrigerated FluMist sprayer contains a single 0.2 mL dose. Each 0.2 mL dose contains 106.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the three strains: A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), and B/Wisconsin/1/2010. 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, and 0.96 mg/dose monobasic potassium phosphate. Each dose contains residual amounts of ovalbumin (< 0.24 mcg/dose), and may also contain residual amounts of gentamicin sulfate (< 0.015 mcg/mL), and ethylenediaminetetraacetic acid (EDTA) (< 0.37 mcg/dose). FluMist contains no preservatives.
The tip attached to the sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. FluMist is a colorless to pale yellow suspension and is clear to slightly cloudy.
I never had heard about porcine gelatin until I started writing these vaccine ingredients articles a few years back. Porcine gelatin is essentially processed pigskins. I'll quote some of the process here in case you don't have time to click the link. Also if anyone's religion or background prohibits any consumption or ingestion of pig or pork products, then please check to see if this porcine (a/k/a pig or pork) gelatin ingredient in the vaccine is permitted.
Acid Pretreatment Process or Porcine Gelatin (Type A Gelatin)
Acid pretreatment is invariably used for porcine gelatin. Pigskins are first dehaired, usually by a combination of steam, rubber paddles, and flame (Farmer, et al., 1982). The pigskins may then be degreased by various methods, such as centrifuged in a rotating drum heated with steam to temperatures between 60° and 65° C. or approximately 150°-160°F. (Hinterwaldner, 1977a). Petroleum-based solvents such as tetrachloroethylene (TCE) may also be used to degrease animals, but this is less common than steam and mechanical methods because of safety and environmental issues (Norris, 1982). Hydrogen peroxide may be used to remove grease passed through a chopper or macerator to cut the skin into uniform sizes (Keenan, 1994). The skins are then soaked at a pH of 1 to 4 with a food-grade mineral acid such as hydrochloric (HCl), phosphoric (H3PO4), or sulfuric (H2SO4) acid for 8 to 30 hours (Hinterwaldner, 1977b; Keenan, 1994; Cole, 2000; Ledward, 2000). This treatment causes the material to swell to two to three times its pre-treatment volume (Ledward, 2000). The acid-treated pigskins are then washed with water to remove impurities. The skins are then extracted with hot water and the extract is filtered through an anion-cation exchange column to reduce ash or mineral levels. The gelatin extract is vacuum concentrated or ultra filtered to a concentration of between 15 and 35%, filtered, pH adjusted to between 3.5 and 6, evaporated to 50% solids, sterilized at temperatures between 248-303°F. for up to 13 seconds, chilled and extruded into noodles approximately 1/8 inch diameter, dried through a multi zone oven at 158°F., and milled to the specified particle size and packaged (Hinterwaldner, 1977a). Acid pretreatment is sometimes used for beef ossein, but this is relatively uncommon (Rose, 1990).
The FDA Approval Letter for Fluvirin by Novartis Vaccines and Diagnostics Limited
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 2012-2013 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/Christchurch/16/2010, NIB-74 (H1N1) (an A/California/7/2009-like virus); A/Victoria/361/2011, IVR-165 (H3N2); and B/ Hubei-Wujiagang/158/2009, NYMC BX-39 (a B/Wisconsin/1/2010-like virus).
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.
The FDA Approval Letter for Fluzone, Fluzone High Dose and Fluzone Intradermal by Sanofi Pasteur
Fluzone High-Dose
Fluzone Intradermal
Fluzone
| Table 6: Fluzone Ingredients Ingredient | Quantity (per dose) | |||
| Fluzone 0.25 mL Dose | Fluzone 0.5 mL Dose |
| ||
| Active Substance: Split influenza virus, inactivated strainsa: | 22.5 mcg HA total | 45 mcg HA total | ||
| A (H1N1) | 7.5 mcg HA | 15 mcg HA | ||
| A (H3N2) | 7.5 mcg HA | 15 mcg HA | ||
| B | 7.5 mcg HA | 15 mcg HA | ||
| Other: | ||||
| Sodium phosphate-buffered isotonic sodium chloride solution | QSb to appropriate volume | QSb to appropriate volume | ||
| Formaldehyde | ≤50 mcg | ≤100 mcg | ||
| Octylphenol Ethoxylate | ≤75 mcg | ≤150 mcg | ||
| Gelatin | 0.05% | 0.05% | ||
| Preservative | ||||
| Single-Dose Presentations | None | None | ||
| Multi-Dose Presentation (Thimerosal) | N/A | 25 mcg mercury | ||
...
Source: FDA
