Flu Vaccine Ingredients & Package Inserts for FDA-Approved Vaccines in the United States of America (2012-2013)

File photo

I 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.

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).

5. Fluvirin (FDA link)

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.

6. Fluzone, Fluzone High-Dose and Fluzone Intradermal (FDA link)

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

FDA Approves Influenza Vaccine Formulations for 2012-2013 Season

I will write a more detailed post in the coming days that will provide links to the specific vaccines and the ingredients of each of these 2012-2013 approved vaccines as I have done in previous years.

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FDA NEWS RELEASE

For Immediate Release: Aug. 13, 2012
Media Inquiries: Heidi Rebello, 301-796-4566, heidi.rebello@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA, OCOD@fda.hhs.gov

FDA approves vaccines for the 2012-2013 influenza season

The U.S. Food and Drug Administration announced today that it has approved the 2012-2013 influenza (flu) vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the United States.

Each year experts from the FDA, the World Health Organization, the Centers for Disease Control and Prevention (CDC), and other public health experts study influenza virus samples and global disease patterns to identify virus strains likely to cause the most illness during the upcoming flu season.

Based on that information and the recommendations of the FDA’s Vaccines and Related Biological Products Advisory Committee, the strains selected for inclusion in the 2012-2013 flu vaccines are:

• A/California/7/2009 (H1N1)-like virus
• A/Victoria/361/2011 (H3N2)-like virus
• B/Wisconsin/1/2010-like virus.

While the H1N1 virus is the same as what was included in the 2011-2012 influenza vaccines, this year’s influenza H3N2 and B viruses differ from those in the 2011-2012 influenza vaccines.

Vaccination remains the cornerstone of preventing influenza, a contagious respiratory disease caused by different influenza viruses infecting the nose, throat and lungs. This year’s seasonal vaccines will provide protection against the three influenza virus strains that global surveillance indicates are likely to be the most common strains circulating during the upcoming season.

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. However, even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

“The best way to prevent influenza is by getting vaccinated each year,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “It is especially important to get vaccinated this year because two of the three virus strains used in this season’s influenza vaccines differ from the strains included in last year’s vaccines.”

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. This leads to more than 200,000 hospitalizations from related complications. Influenza seasons are unpredictable and can be severe, with annual influenza-related deaths ranging from a low of about 3,000 to a high of 49,000 people in the U.S. The CDC’s Advisory Committee on Immunization Practices, recommends that everyone six months of age and older receive an annual influenza vaccine.

Health care providers play an important role in advising their patients to get vaccinated each year and should also protect themselves, their patients, their family, and the community from influenza by getting vaccinated.

The manufacturers licensed to produce the nation’s 2012-2013 flu vaccines and the brand names of the vaccines for the upcoming flu season are:

• Afluria, manufactured by CSL Limited;
• Fluarix, manufactured by GlaxoSmithKline Biologicals;
• FluLaval, manufactured by ID Biomedical Corporation;
• FluMist, manufactured by MedImmune Vaccines Inc.;
• Fluvirin, manufactured by Novartis Vaccines and Diagnostics Limited; and
• Fluzone, Fluzone High-Dose and Fluzone Intradermal, manufactured by Sanofi Pasteur.

For more information:

• Flu.gov: consumer site for flu information

• FDA: Influenza Vaccine Safety & Availability

• FDA Lot Release Information of the 2012-2013 Influenza Vaccine

• CDC: Seasonal Influenza – Who should get vaccinated against influenza (Flu)

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Texas Department of State Health Services to Aerial Drop 1.8 Million Doses of Rabies Vaccine This Month

I have to thank a Facebook friend for posting a news story today that caused me to research this matter about the aerial vaccination program in Texas. Texas says that the annual aerial vaccine program has been effective in controlling rabies, but I wouldn't expect the State to say anything else. 1.8 million doses of a vaccine is a WHOLE lot of doses, so what happens to the vaccines that aren't consumed by animals? Could these vaccines somehow get into the food and water tables? And what ingredients are in this rabies vaccine?

I guess I should do a little bit more research on this vaccine to get answers to these questions, but until then, the brochure for RABORAL V-RG® can be viewed here.

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DSHS Combats Rabies With Aerial Vaccine Drop
News Release
Jan. 2, 2012

The Texas Department of State Health Services this week begins its annual airdrop of rabies vaccine baits over portions of southern and western Texas in the continuing effort to protect people and livestock from rabies. Planes will take off from airports in Zapata and Alpine around dawn Wednesday, Jan. 4 and from Del Rio on Thursday, Jan. 12. They will drop about 1.8 million doses of rabies vaccine over the next month as part of the DSHS Oral Rabies Vaccination Program.

“This approach has been a huge success,” said veterinarian Ernest Oertli, the vaccination program’s director. “We haven’t seen a single human case of rabies in the areas covered by the program since it started in 1995, and the number of animal cases has dropped dramatically.”

Animal cases of the canine strain of rabies in southern Texas fell from 122 in 1994 to zero in 2000. There have since been single cases in 2001 and 2004. The fox strain, prevalent in western Texas, dropped from 244 animal cases in 1995, the year before the project expanded to that area, to zero in 2010 and 2011.

“We have effectively eliminated these two strains of rabies from Texas,” said Oertli. “Now our goal is prevent them from being reintroduced as animals move in and out of the state.”

The vaccine dose is enclosed in a small packet dipped in fish oil and coated with fish meal crumbles. The baits don’t pose any risk to humans, but people should avoid handling them since human contact makes it less likely a wild animal will eat the baits.

Rabies is a deadly virus spread through the saliva of infected animals, usually by a bite. Preventing rabies is critical because once a person or animal displays symptoms, the disease is almost always fatal.

DSHS urges everyone to have their pets vaccinated against rabies, as required by law. Vaccinating domestic animals is essential to stopping the spread of rabies.

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(News Media Contact: Chris Van Deusen, DSHS Assistant Press Officer, 512-776-7753)

DSHS Press Office on Twitter

Last updated January 02, 2012

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.

CVS Grim Reaper Promotes Flu Shot?

The picture might be funny if there weren't toxic ingredients like formaldehyde in these flu vaccines. I haven't checked out the 2011 package inserts, but I did an intensive analysis on this blog for various flu vaccines in 2009 and 2010.

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

Fluzone (Influenza Virus Vaccine) for intramuscular injection, Fluzone High-Dose (Influenza Virus Vaccine) for intramuscular injection, and Fluzone Intradermal (Influenza Virus Vaccine) for intradermal injection are inactivated influenza virus vaccines, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde.

Finland's National Narcolepsy Task Force Reports Increased Risk of Narcolepsy Observed among Children Given Pandemrix® H1N1 Vaccine

This recent report out of Finland links the Pandemrix® swine flu shot and narcolepsy. The National Narcolepsy Task Force will release the full report on August 31, 2011. The press release follows below after my text.

For further information on Pandemrix® (including the package insert and ingredients), check out my previous blog article GlaxoSmithKline's Pandemrix Approved for Use in the United Kingdom (Ingredients Include Squalene, Thimerosal and H1N1).

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Increased risk of narcolepsy observed among children and adolescents vaccinated with Pandemrix®

1 Feb 2011

Among those 4-19 years of age who received Pandemrix®-vaccine had a manifold increased risk of falling ill with narcolepsy during the 8 months following vaccination in comparison to those unvaccinated in the same age group. Based on the evaluation done so far, the National Narcolepsy Task Force finds it probable that Pandemrix®-vaccination contributed to the observed increase in incidence of narcolepsy among those 4 -19 years of age. Currently, the most likely explanation is that the increase in narcolepsy is by joint effect of the vaccine and some other factor(s). At the moment, there is no evidence that the increase in narcolepsy observed in Finland could be attributed to the vaccine lots used. The results can be read in the Interim Report of the Task Force which is published on February 1st, 2011.

The association of Pandemrix-vaccination and narcolepsy was studied using extensive registry based data. Data gathered from hospital discharge registries on patients fallen ill with narcolepsy during years 2009-10 was linked with data from primary care records on pandemic vaccination. The observed association is so evident that it is unlikely that other so-called confounding factors could fully explain the phenomenon.

In Finland during years 2009–10, 60 children and adolescents aged 4-19 years fell ill with narcolepsy. These figures base on data from hospitals and primary care, and the review of individual patient records by a panel of neurologists and sleep researchers. Of those fallen ill, 52 (almost 90 percent) had received Pandemrix® vaccine, while the vaccine coverage in the entire age group was 70 percent. Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was 9-fold in comparison to those unvaccinated in the same age group. This increase was most pronounced among those 5–15 years of age. No cases were observed among those under 4 years of age. Also, no increase in cases of narcolepsy or signs of vaccination impacting risk of falling ill with narcolepsy was observed among those above 19 years of age.

In addition to Finland, increase in cases of narcolepsy observed only in Sweden and Iceland

In 2009, among countries using similar pandemic vaccine as was used in Finland, an increase in cases of narcolepsy has been observed only in Finland, Sweden and Iceland. Contrary to the observations in Finland, narcolepsy has occurred in greater numbers than expected also among unvaccinated children and teenagers in Iceland.

The association between narcolepsy and PandemrixR vaccine requires more investigations

During the coming months, these preliminary register based results will be confirmed in Finland. In further investigations, special attention will be given to infections and other stimuli in close time association with the pandemic vaccination. The significance of the possible joint effects will be explored.

In addition, other significant co-factors contributing to the onset of narcolepsy will be evaluated in epidemiologic, immunologic and genetic studies planned. The main aim of the immunologic studies is to clarify, whether the immunological responses to the different components of the Pandemrix® vaccine and to the A(H1N1) virus among those children and teenagers with genetic disposition to narcolepsy and those fallen ill with narcolepsy differ from the immunological responses of other children and teenagers not belonging to these risk groups.

It is also of utmost importance to find out whether the association is observed also elsewhere than in Finland. At present, Finland is participating in the ECDC contracted, VAESO led narcolepsy background incidence and case control studies which are being conducted in 9 European Union countries by pharmacovigilance researchers from Public Health Institutes, Regulatory Agencies and Universities. These studies will evaluate the contribution of the pandemic vaccines and other risk factors in the onset of narcolepsy, and confirm whether increase in incidence in narcolepsy is seen in other countries. The outcomes of these studies will be reported during early summer 2011.

By January 24, 2011, 56 notifications of narcolepsy in association with Pandemrix® vaccination have been received by the National Vaccine Adverse Events Register maintained at the National Institute of Health and Welfare in Finland. Of these, 54 cases belonged to the age group of 4–19 years. Among most of the notified cases, the onset of symptoms of narcolepsy had started approximately two months following Pandemrix® vaccination.

The final report from the National Narcolepsy Task Force will be released by 31st August 2011.

Further information

WHO: Pandemrix® vaccine and increased risk of narcolepsy

Terhi Kilpi
Director of Department of Vaccines and Immune Protection, Chairman of the Task Force
National Institute of Health and Welfare, THL
tel +358 20 610 8678

Hanna Nohynek
Vaccine Safety Officer, Secretary of the Task Force
National Institute of Health and Welfare,THL
Tel +358 20 610 8246

Short address: http://www.thl.fi/doc/en/24103

Is Crucell's PER.C6® "Immortal Cell" Vaccine Technology Created Using Human Fetal Retinal Cells?

I'm not stating as fact that Crucell created its PER.C6® vaccine technology from human fetal retina cells. I'm just pointing out a PDF document (Investor and Analyst Day March 12th, 2008 London) that exists on Crucell's servers (I found it by a random Google search) (see also: Crucell Investor Day March 12, 2008) where John Lewis, VP Scientific Affairs, mentions that human fetal retinal cells (check out page 5 of the PDF) are most sensitive to transformation with E1. The document also states that the E1 gene was taken from Ad5 and used to transfect primary human retinal cells.

PER.C6® technology
A human designer cell line for the efficient development and large-scale manufacturing of biopharmaceutical products [e.g., vaccines, monoclonal antibodies and gene therapy products]. The PER.C6® cell line is made from a single healthy, human cell that has been purposefully immortalized so that it can grow indefinitely and can be expanded efficiently without the need for materials that allow cell attachment (i.e. microcarriers) or the need for serum derived from non-human sources

Based on the PDF document, I believe the single, healthy, "immortal" cell referred to above may be the one that is created from human retina cells -- particularly fetal retina cells using E1 produced from Ad5. The immortal cell is then used to create a master cell bank for vaccine and biopharmaceutical product production. Per Crucell, "PER.C6® cells can replicate indefinitely..."

Nevertheless, this is where my ignorance in genetics is going to cause me to leave the highway, because I cannot make an educated opinion without that knowledge. However, if you have expertise in that area, I believe that the article Size and location of the transforming region in human adenovirus type 5 DNA gives background on what Ad5 is. Perhaps AD5 is a Crucell proprietary version of the human adenovirus type 5 DNA.

For further reading: The human cell line PER.C6 provides a new manufacturing system for the production of influenza vaccines

Remixx World! briefly discussed vaccines created from human retina cells last year in What Ingredients are in the H1N1 "Swine Flu" Vaccine? (Yes, Intranasal Contains Live H1N1 Virus)(Updated as of 11/30/2009)

Source: Crucell

Saudi Arabia Imposes Mandatory Vaccinations on Foreign Pilgrims Coming for Haj and Umrah

The mandatory vaccination mandates are picking up steam again just as they did last year in 2009. For all the Haj and Umrah pilgrims, take note.

It is mandatory for foreign pilgrims coming on Haj and Umrah this year to be vaccinated for communicable diseases such as yellow fever, cerebrospinal meningitis fever, polio and influenza, according to Dr. Khalid Al-Marghalani, the Ministry of Health’s (MoH) spokesperson.

Al-Marghalani said the MoH is following instructions from the World Health Organization (WHO) about the latest developments on epidemics, particularly from African, Asian and South American countries.

Source: Saudi Gazette

American Academy of Pediatrics Recommends Mandatory Flu Vaccines for All Health Care Workers

I'm glad that I'm not a health care worker. I wonder what the odds are that the Federal government or one or more of the States will impose mandatory vaccinations on its citizens. At that point, there will be a serious conflict between the government's argument of a compelling state interest against a person's individual liberty to refuse a vaccine.

The mandatory vaccinations will start with the health care workers, teachers, students and TSA airport agents. If the mandatory vaccination campaign is successful in those areas, then the government will expand the program to other areas until vaccinations are constructively mandatory.

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AAP Recommends Mandatory Flu Vaccine for All Health Care Workers

For Immediate Release:

Health-care associated influenza outbreaks are a common and serious public health problem that contribute significantly to patient morbidity and mortality and create a financial burden on health care systems. In a new policy statement, the American Academy of Pediatrics (AAP) recommends that all health care personnel should be required to receive an annual influenza vaccine. The policy, "Recommendation for Mandatory Influenza Immunization of All Health Care Personnel," published in the October 2010 print issue of Pediatrics (published online Sept. 13), states that "despite the efforts of many organizations to improve influenza immunization rates with the use of voluntary campaigns, influenza coverage among health care personnel remains unacceptably low." Annual influenza epidemics account for 610 660 life-years lost, 3.1 million days of hospitalization, and 31.4 million outpatient visits. Flu generates a cost burden of approximately $87 billion per year in the United States. Mandatory influenza immunization for all health care personnel is "ethically justified, necessary and long overdue to ensure patient safety," according to the statement. The influenza vaccine is safe, effective, and cost-effective, so health care organizations must work to assuage common fears and misconceptions about the influenza virus and the vaccine.

FLASHBACK: H1N1 "Swine Flu" Virus To Be Included in 2010-2011 Seasonal Flu Vaccine

Remixx World! has discussed the H1N1 virus and vaccine exhaustively over the last fifteen (15) months. If you are a new reader to Remixx World! and missed those articles, please click this H1N1 tag or this archive search to review the past research and links.

Remixx World! has always been anti-H1N1 vaccine and I hope that my links helped people make informed choices about the ingredients that are included in the H1N1 "swine flu" vaccine. While my site may not have made a difference in the world, most people in America did not get the H1N1 vaccine despite an excess of supply.

Nevertheless, the government does not accept failure, so instead of promoting the H1N1 vaccine as a stand-alone vaccine, the government will now include the H1N1 virus in the 2010-2011 seasonal flu vaccine.

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Protection Against 2009 H1N1 To Be Included in 2010-2011 Seasonal Flu Vaccine

February 22, 2010

A key U.S. Food and Drug Administration Advisory Committee recommended today that protection against the 2009 H1N1 virus, which was first identified last April, be included in the 2010-2011 seasonal influenza vaccine starting this fall. That means that, barring some unforeseen circumstance, this fall, most Americans will be able to return to the traditional routine of having one flu vaccine to protect them against the major circulating flu viruses. As is always the case with seasonal vaccine, younger children who have never had a seasonal vaccine will still need two doses.

Today’s recommendation to include protection against the 2009 H1N1 flu strain in next season’s flu vaccine was made by the FDA’s Vaccines and Related Biological Products Advisory Committee. The committee’s recommendations typically guide vaccine manufacturers in preparing each season’s flu vaccines. The World Health Organization has made the same recommendation.

This recommendation will go into effect for next fall’s flu season. In the meantime, you can still protect yourself against the H1N1 flu by getting your H1N1 vaccine now. Supplies are still available and getting immunized now can protect you against H1N1 while it continues to circulate. H1N1 has led to nearly 260,000 hospitalizations and approximately 12,000 deaths in the United States. Use our handy vaccine locator to find a vaccination location near you.

Bavarian Nordic Delivers 1 Million Doses of IMVAMUNE® Smallpox Vaccine Developed Under U.S. Biopreparedness Program for Strategic National Stockpile

Please take note that this IMVAMUNE® smallpox vaccine also falls under the "mark-of-the-beast" US666/EU666 regulatory status index like certain flu vaccines from last year. If the aforementioned link is not available, click this backup link.

Regulatory/Status Index:

application expected (2007-8) in U.S.
biodefense stockpile (U.S.)
biodefense stockpile, European countries
controlled/gov’t distribution in European counties
controlled/gov’t distribution in U.S.
priority review status
EU666 Biodefense stockpile
UM100 Controlled/Gov't Distribution in US
US666 Biodefense stockpile
US001 FDA application expected
EM160 Controlled/Gov't Distribution in EU

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Bavarian Nordic Delivers 1 Million Doses of First Vaccine Developed Under U.S. Biopreparedness Program to the Strategic National Stockpile

- Smallpox Vaccine Represents the Company's First Major U.S. Product Sale

KVISTGÅRD, Denmark -July 13, 2010 - Bavarian Nordic A/S (NASDAQ OMX: BAVA) announced today that it has delivered 1 million doses of its smallpox vaccine IMVAMUNE® to the U.S. Strategic National Stockpile for use in the event of a smallpox bioterrorism attack on the U.S.

IMVAMUNE® is the first vaccine successfully developed under Project BioShield, a U.S. program created by Congress in 2004 to develop and purchase medicines and vaccines to protect the American public from bioterrorism attacks. Bioterrorism experts are concerned about the possibility of an attack on the US that exposes the population to the smallpox virus.

IMVAMUNE® was clinically developed and manufactured under contracts with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health & Human Services (HHS), as well as the National Institutes of Health (NIH). Under the BARDA contract, Bavarian Nordic will deliver 20 million doses of IMVAMUNE® to the U.S. Strategic National Stockpile, with an option for 60 million more doses.

"We are gratified that the U.S. Government has added our vaccine to the Strategic National Stockpile. This represents a significant milestone for our company, our first major sale to the U.S.," said Bavarian Nordic President and CEO Anders Hedegaard. "Our partnership with NIH, BARDA and HHS over the recent years is a case study in successful public-private partnerships to combat bioterrorism. We look forward to continuing that partnership through other contracts with the U.S government."

IMVAMUNE® is a non-replicating strain of vaccinia virus that, unlike conventional smallpox vaccines, does not have the ability to replicate in human cells, thereby eliminating risk of accidental infection. Currently stockpiled smallpox vaccines are based on a replicating form of the vaccinia virus, and are therefore considered inappropriate for up to 25 percent of the population that may be immunocompromised or have other medical conditions that contraindicate a replicating viral vaccine. While studies indicate that IMVAMUNE® is likely to be well tolerated in a broad population, it is currently being stockpiled for emergency use specifically in people with compromised immune systems, e.g. HIV/AIDS patients.

Mr. Hedegaard said the delivery authorization marks Bavarian Nordic's "transformation from a fledgling biotech to a fully-integrated research innovator with proven manufacturing and regulatory experience." On March 17, FDA concluded that Bavarian Nordic has fulfilled all requirements to support the delivery of IMVAMUNE® to the U.S. Government.

The Need for a Non-Replicating Smallpox Vaccine

Security experts-including the U.S. Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism-expect that an act of biological terrorism is more likely than nuclear terrorism. Compared to a nuclear weapon, a biological weapon is much cheaper to produce, the starting materials are more accessible, and less diversity of technological experience is required. HHS considers smallpox a high-priority threat.

Because vaccination against smallpox is no longer standard, an increasing proportion of the population is unprotected and vulnerable to a bioterrorism attack. Smallpox presents a continued global threat for which countries need to be prepared.

The U.S. Strategic National Stockpile includes stocks of conventional smallpox vaccines made from a live, replicating form of the vaccinia virus. These vaccines were used in a global effort to wipe out the disease and resulted in worldwide eradication by 1980.

Conventional smallpox vaccines have been associated with high rates of serious adverse events, including death and severe disability. The 2003 U.S. smallpox vaccination program for health care workers, which involved more than 37,000 individuals, confirmed these severe side effects.

IMVAMUNE® (MVA-BN®) is a non-replicating smallpox vaccine derived from the modified vaccinia virus Ankara. Since IMVAMUNE® does not have the ability to replicate in human cells, clinical trial data from 2,800 people in 15 ongoing or completed studies indicates that IMVAMUNE® has a favorable safety profile and is well tolerated, including in individuals with compromised immune systems who are currently not eligible for conventional smallpox vaccines.

BARDA highlighted the need to protect this vulnerable population in its 2010 Broad Agency Announcement for Medical Countermeasure Development, in which it noted the need for "attenuated smallpox vaccine - sufficient quantity to protect 66 M [million] people, comprising those for whom smallpox vaccine is contraindicated and their household contacts," which includes immunocompromised and atopic dermatitis patients.

About Bavarian Nordic's Contracts with the U.S. Government

Bavarian Nordic initiated the development of IMVAMUNE® in 1999 and began the first clinical study in 2001. In 2003, Bavarian Nordic was awarded a contract, valued at $29 million, from the U.S. National Institutes of Health (NIH), for the further development of IMVAMUNE®. In 2004, Bavarian Nordic was awarded its second U.S. Government contract, valued at $115 million, to continue advanced development of IMVAMUNE® including clinical trials in individuals with compromised immune systems. In parallel, Bavarian Nordic invested $100 million in the construction of an industrialized manufacturing facility specifically designed to meet the potential demands for IMVAMUNE® by the U.S. Government.

In June 2007, the U.S. Government awarded Bavarian Nordic its third contract for $500 million to manufacture and deliver 20 million doses of IMVAMUNE® for the Strategic National Stockpile. This contract includes an option to purchase an additional 60 million doses. In November 2009, BARDA awarded another contract with a prospective value of up to $40 million to Bavarian Nordic for development of a freeze-dried version of IMVAMUNE®. IMVAMUNE® is the first entirely new biodefense vaccine developed under Project BioShield for inclusion in the Strategic National Stockpile.

BARDA, a division of HHS, manages Project BioShield and is responsible for working with biotechnology and pharmaceutical companies to develop and stockpile effective medicines and vaccines against bioweapons, pandemic influenza, and other emerging infectious diseases.

This release will have no impact on the company's financial guidance for 2010.

Bavarian Nordic: An Established Biodefense Leader

Founded in 1994, Bavarian Nordic is a leading industrial biotechnology company working to target unmet medical needs by developing and producing vaccines for the prevention and treatment of life-threatening diseases. With more than a decade of experience manufacturing smallpox vaccines and working with the U.S. Government, Bavarian Nordic has grown from a biotechnology company to a fully integrated biopharmaceutical company with proven manufacturing and regulatory expertise.

Forward-looking statements

This announcement includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which are outside of our control that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.


Contact:

Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64