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

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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

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

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.

Many Doctors in Maharashtra India Refuse to Take H1N1 "Swine Flu" Vaccine

It has been a year or so since this blog was mainly focused on the H1N1 "swine flu" pandemic, but that doesn't mean that the H1N1 has left the news. In fact, many countries around the world are now dealing with the same vaccination issues that people here in the United States were dealing with a few months ago. Luckily, there are skeptics of the vaccine all around the world.

Doubting its effectiveness and possible side-effects many doctors in Maharashtra have refused to take the Swine flu vaccine, prompting the State Government to mull over the large stock of vaccines. Doctors and paramedical staff in Government hospitals have refused to take the swine flu vaccine, an official said.

No decision could be reached at in a meeting here recently with Health Department on what to do with the vaccine stock, the official said.

Source: The Hindustan Times

U.S. Government to Burn 40 Million Doses of Expired Swine Flu Vaccine as Sebelius' H1N1 Pandemic Sham Costs Taxpayers $260 Million

HHS Secretary Kathleen Sebelius

Thank you Madame Secretary for all the fear and paranoia. Only fear and paranoia would cause a government to buy millions of doses of a toxic H1N1 "swine flu" vaccine that no one wanted and that must now be incinerated. That's $260 million literally up in smoke for a false pandemic.

What is the name of the person who was responsible for ordering so many doses of the H1N1 vaccine that are now wasted? Unless that person is identified, then the buck stops with Kathleen Sebelius. She is responsible for a $260 million waste, because she continually promoted the vaccine like the H1N1 "swine flu" was the end of the world instead of it being nothing more than a mild flu.

About a quarter of the swine flu vaccine produced for the U.S. public has expired -- meaning that a whopping 40 million doses worth about $260 million is being written off as trash.

"It's a lot, by historical standards," said Jerry Weir, who oversees vaccine research and review for the U.S. Food and Drug Administration.

Source: WSBTV-2

Department of Health and Human Services (HHS) Says H1N1 "Swine Flu" Pandemic Emergency Is Over

So after billions of wasted taxpayer dollars and paranoia, the government finally realizes that the H1N1 "swine flu" was a dud. I wrote a lot about the H1N1 in 2009 and those topics put this blog on the map. Now, the Health & Human Services reportedly says the H1N1 pandemic emergency is over. By the way, has anyone seen Sebelius lately, because she has been missing in action over the last few weeks?

Federal officials today allowed the public health emergency declaration that was prompted by the H1N1 influenza outbreak last year to lapse, signaling an end to emergency authorizations for certain special uses of antiviral drugs and other items.

The Department of Health and Human Services (HHS) first declared the emergency Apr 26, 2009, and has renewed it quarterly since then, the last time on Mar 26. "The current March 26 determination is scheduled to expire on June 23, and, based on the current circumstances, will not be renewed," says a statement released by an HHS official today.

Source: CIDRAP

Cuba to Begin Vaccinating More Than 1.1 Million Against H1N1 "Swine Flu"

As we approach the one-year anniversary of the H1N1 "swine flu" hype, are we about to see the cycle repeat itself again this April? For example, Cuba is about to get into the act and begin vaccinating its population after first refusing to take the vaccine.

Cuba will begin vaccinating nearly 10 percent of its citizens against swine flu next week, reversing its previous skepticism about the high cost and effectiveness of immunization to combat the virus.

Source: Virgin Islands News Online

India to Offer Sanofi Pasteur's H1N1 "Swine Flu" Vaccine Starting Next Week

India is finally getting the H1N1 "swine flu" vaccine. Why has it taken so long for India to get the toxic swine flu vaccine when the rest of the world has had it for months?

Here is the package insert for Sanofi Pasteur's H1N1 "swine flu" vaccine in the United States of America that was first approved in 1980. The ingredients may also be viewed below. I do not know if the Indian vaccine will be the same as the one here in America, but I will check.

Influenza A (H1N1) 2009 Monovalent Vaccine, an inactivated influenza virus vaccine, for intramuscular use, is prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, polyethylene glycol p-isooctylphenyl ether (Triton® X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.

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.

Influenza A (H1N1) 2009 Monvalent Vaccine is a sterile clear to a slightly opalescent suspension.

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.

Source: FDA ; Sify News

Maryland Teenager Paralyzed with Transverse Mylitis After Getting H1N1 "Swine Flu" Vaccine

This story of a Maryland teenager becoming a paraplegic after the swine flu vaccine is yet another sad story of a person whose life will never be the same because of the toxic H1N1 "swine flu" vaccine. It is obvious that this teenager was the victim of propaganda, because the story says that he was the one who urged his parents to get him the vaccine. This teenager probably had everyone at his school promoting the vaccine and telling everyone to get it. Well, he got it and now his life will never be the same.

Robert Beckham, 16, is in rehab at Mount Washington Pediatric Hospital, where he and his parents, Belinda and Tom, are learning to cope with his new status as a paraplegic...

[Sinai pediatric neurologist Dr. Yuval] Shafrir said Robert is being treated for a rare condition called transverse mylitis in which a segment of Robert's spinal cord was destroyed by his own immune system.

Transverse mylitis is a disease that can occur after infection, but in this case, Shafrir said it was a medically unpredictable reaction to a vaccination that's being given in schools all over the country.

And to make matters worse, the teenager and his parents will not be able to get any financial assistance from the government due to the vaccine's experimental nature.

"If he had received the regular flu vaccine, the family would be able to file a claim with the National Vaccine Injury Compensation Program," said attorney Clifford Shoemaker. "But because it was the swine flu program, which falls under the same bill as terrorism … the family will get very little in compensation for what's happened to this child."

Source: WBALTV.com (Channel 11 - Baltimore)

Kentucky Public Health Department's H1N1 "Swine Flu" Advertisement Portrays Vaccine Skeptics as Raving Lunatics

This video makes vaccine skeptics and people who discuss vaccine ingredients seem crazy. I know that the video's creators were trying to be funny, but they are actually idiots. Instead of discussing whether the H1N1 "swine flu" vaccine comes from platypus milk, a 700-year portal or secret alien technology, why doesn't this video talk about the real ingredients in the H1N "swine flu" vaccine?

Why won't the Kentucky Department of Public Health talk about the thimerosal, adjuvant, formaldehyde and H1N1 virus ingredients that are in the vaccine? I do not recall anyone saying the H1N1 vaccine contains platypus milk, portal residue or alien traces. No, people are exposing the toxic ingredients and Johnny Nonsense propaganda hype of the H1N1 vaccine.

Shame on you, Kentucky Department of Public Health! How much is Sebelius paying you to produce this crap?


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Paul Joseph Watson
Prison Planet.com
Thursday, March 4, 2010

A glib 33 second propaganda ad produced by the Kentucky Department for Public Health portrays skeptics of the swine flu vaccine as raving lunatics, despite the fact that the head of the Council of Europe’s investigation into the 2009 outbreak labeled it “one of the greatest medical scandals of the century.”

The commercial, which is entitled ‘H1N1 Vaccine Myths,’ features a group of office workers spewing ridiculous theories about the swine flu vaccine that have never been embraced by any vaccine skeptic, in an attempt to build a classic straw man and smear people who question the necessity for taking the shot as unstable lunatics.

The actors in the ad debate whether the H1N1 vaccine was “made from platypus milk,” or whether it “makes you susceptible to hypnotic suggestion.”

The clip ends by another actor in the ad stating, “It was made from secret alien technology found on the moon.”

“Some folks believe anything,” states an assertive female voice, “The swine flu vaccine is safe, effective, and you still need it, learn more at Kentucky’s flu website, that way you can separate the fact from the fiction.”

Unfortunately, Kentucky health authorities have completely failed to separate the fact from the fiction during the course of their 33 second ad, because they attribute outlandish theories about the vaccine to skeptics who have never even uttered such things.

While the advertisement frames suspicion about the vaccine in the context of tin-foil hat wearing madness, in reality the swine flu pandemic has been denounced as a gargantuan hoax not by demented paranoid psychotics, but by the head of the Council of Europe’s Sub-committee on Health, Dr. Wolfgang Wodarg, who as the chief of a major investigation into the H1N1 outbreak, labeled the case a “fake pandemic” manufactured by pharmaceutical companies in league with the WHO to make vast profits while endangering public health.

In a separate interview, Wodarg labeled the pandemic, “One of the greatest medical scandals of the century.”

Makers of the swine flu vaccine such as CSL Limited and GlaxoSmithKine saw their profit margin soar by 63 per cent and 30 per cent respectively on the back of swine flu fearmongering that was dutifully practiced in spades by the corporate media throughout 2009. Roche made a whopping 12 times the profit during the second quarter of 2009 compared to the same period in 2008 as a result of the scare.

As we highlighted at the time, the very vaccine inserts that were publicly available clearly stated that the shot could cause Guillain-Barre Syndrome, Vasculitis, Paralysis, Anaphylactic Shock And Death. The vaccines also contained mercury and squalene, which have been directly linked with autism and Gulf War syndrome respectively.

Concerns about such dangers grew to such an extent that the majority of Americans told a Fox News poll that they thought the vaccine was more risky than catching the actual swine flu virus. Separate polls showed that the majority of doctors, nurses and health workers in the UK refused to take the shot.

In November 2009, take up of the vaccine was so slow that the U.S. government was forced to appoint what the media ludicrously billed as an “independent” group of health advisors whose job it was to whitewash adverse reactions to the swine flu vaccine and “explain” them to the public as mere coincidence. The “independent” group was lead by Dr. Marie McCormick of the Harvard School of Public Health, who had spent the last 10 years whitewashing reports of a link between vaccines and autism.

Suspicions surrounding the safety of the vaccine were confirmed when it was revealed that German Chancellor Angela Merkel and government ministers would be taking a shot that did “not contain disputed additives — contrary to the vaccine for the remainder of the population.”

This commercial represents a desperate last ditch effort on behalf of health authorities to try and shift the endless batches of unused H1N1 vaccines that still remain precisely because millions of Americans believed the lunatics who warned them about the dangers of the shot and refused to take it.

So if you really do think you “still need” the H1N1 shot after it has been completely exposed as an international scandal by one of the premiere investigatory bodies in Europe, then roll up your sleeve and knock yourself out, after all, it’s “safe” and “effective” according to the government, but apparently not “safe” and “effective” enough for the political class in major western countries to take the same injection that you’ll be getting.