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US Flu Vaccine Ingredients Are Not What You're Told (Part 1 of 2)
by Heidi Stevenson
26 October 2009
Weaving one's way through the tangle of swine flu (H1N1) vaccine claims and counterclaims grows more difficult by the day, and it seems to be intentional. Claims are made that America's H1N1 vaccines don't have thimerosol, that they do have thimerosol. That there is no squalene/there is squalene...there are no adjuvants/yes there are...they use live viruses/no, they're killed viruses. Not one of these statements is absolutely true or false.
The truth is that there are several vaccines being used, and each one has different qualities. The purpose of this article is to untie the tangles and lay out the threads so that you can see precisely what is and is not true.
As of today, I've been able to identify eight different vaccines, by six different manufacturers, that have received FDA approval for swine flu. Some of these come in more than one variety. We'll tackle each of them individually, with a focus on the adjuvant squalene and the preservative thimerosol, which contains mercury, on the method of delivery, the ages approved for delivery, and when possible on the testing method used.
GlaxoSmithKline's Pandemrix
- Squalene: Yes. It is in the adjuvant AS03.
- Mercury: Yes, in preservative thimerosol.
- Eggs in Production: Yes.
- Delivery Method: Injection.
- Testing: The virus used in testing is an H5N1 variety, not swine flu H1N1. The final product for use on the public has not been tested with H1N1. The H5N1 product was tested on people aged 18 through 60, all considered healthy.
- Ages Approved: 6 months and over.
- Dosage: Two doses, 21 days apart, recommended.
- Note: Pandemrix is the vaccine approved for use in the UK.
GlaxoSmithKline's Arepanrix
- Squalene: Yes. It is in the adjuvant AS03.
- Mercury: Yes, in preservative thimerosol.
- Eggs in Production: Yes.
- Delivery Method: Injection.
- Testing: The virus used in testing is an H5N1 variety, not swine flu H1N1. The final product for use on the public has not been tested with H1N1. The H5N1 product was tested on people aged 18 through 60, all considered healthy.
- Ages Approved: Ages 6 months and over.
- Dosage: Two doses, 21 days apart, recommended.
- Note: This appears to be the same vaccine as Pandemrix, renamed and retested for use in Canada.
Novartis's Focetria
- Squalene: Yes. It is in the adjuvant MF59.
- Mercury: In single dose vials, mercury that was used during manufacturing has been removed, so that it is less than or equal to 1 µg per .5 mL dose. Multi-dose vials contain thimerosol.
- Eggs in Production: Yes.
- Delivery Method: Injection.
- Testing: Testing was done with H5N1, H9N2, and H5N3 viruses, not H1N1. The final product for use on the public has not been tested with H1N1. Tests were done on people aged 18 through 60. Subjects over age 60 were tested only with adjuvanted vaccine; their results showed titres (blood antibody concentrations) that were significantly lower than in younger people.
- Ages Approved: 4 and over.
Novartis's Fluvirin
- Squalene: No.
- Mercury: Yes, in preservative thimerosol.
- Eggs in Production: Yes.
- Delivery Method: Injection.
- Testing: Fluvirin for different flu viruses has been in use for many years. It has been tested once on children ages 4-18, and 12 times in adults aged 18-64. The H1N1 virus has not been tested.
- Ages Approved: 4 and over.
- Note: Fluvirin is a trivalent vaccine, including H1N1 and types A and B flu viruses.
CSL's Afluria
- Squalene: No.
- Mercury: The single-dose syringe has no thimerosol. The multi-dose vial does contain thimerosol.
- Eggs in Production: Yes.
- Delivery Method: Injection.
- Testing: Tested on ages 18-65, all defined as healthy, plus one study on ages over 65, with results showing less significant responses. The vaccine is trivalent and all three virus types, H3N1, B Strain, and H1N1 (but not the current swine flu), were tested. Afluria has been in existence, without the current H1N1 vaccine, for several years. No testing for current H1N1 pandemic.
- Ages Approved: 18 and over.
- Note: The package insert states, "There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA."
Sanofi Pasteur's Fluzone
- Squalene: No.
- Mercury: Single-dose has no thimerosol. Multi-dose vial contains thimerosol.
- Eggs in Production: Yes.
- Delivery Method: Injection.
- Testing: Vaccine existed before current swine flu epidemic. Testing preexists this year's pandemic. No testing for current H1N1 pandemic.
- Ages Approved: Sanofi Pasteur suggests use in ages 6 months and over, and recommends its use in children from 6 months of age who are on "chronic aspirin therapy".
Baxter's Celvapan
- Squalene: No.
- Mercury: No.
- Eggs in Production: No.
- Delivery Method: Injection.
- Testing: Strains of H5N1 virus were used in testing. The final product has not been tested with H1N1. It was tested on adults ages 18-59 and age 60 and over, all defined as healthy. Two vaccinations were given 42 days apart. Results in subjects age 60 and over were significantly poorer than in those ages 18-59. Trials on children are planned.
- Ages Approved: Unable to find any advisory on age approval.
- Note: The virus used in Celvapan is not grown in eggs, but in the kidneys of African green monkeys.
Medimmune's FluMist
- Squalene: No.
- Mercury: No.
- Eggs in Production: Yes.
- Delivery Method: Nasal spray.
- Testing: Vaccine existed before current swine flu epidemic. Testing preexists this year's pandemic. No testing for current H1N1 pandemic.
- Ages Approved: Children over age 2 through adults up to age 50. See next item for contraindications to FluMist.
- Note: Does not use killed (inactivated) virus. Uses live attenuated virus. FluMist should not be given to:
- Children under age 2.
- Adults age 50 or over.
- Pregnant women.
- Women breastfeeding babies.
- Anyone with a weakened immune system.
- Anyone with a chronic health condition, such as heart disease, lung disease, asthma, kidney disease, liver disease, diabetes or other metabolic disorder, anemia or other blood disorder.
- Children under age 5 with asthma or episodes of wheezing.
- Anyone with muscle or nerve disorders, such as cerebral palsy, that can result in breathing or swallowing problems.
- Children or adults on aspirin treatment.
- Anyone in contact with someone who has a severely weakened immune system.
There is a new risk hidden amongst this information—the potential for a new, more virulent, influenza virus to develop. The next article, Potential of Virulent New Disease Among Risks of Swine Flu Vaccine, reviews these vaccines and discusses the potential for a mutated influenza to develop from one of them.
References:
- Focetria Package Insert (PDF)
- Focetria Science (PDF)
- Fluvirin Package Insert (PDF)
- Fluzone Package Insert (PDF)
- Afluria Package Insert (PDF)
- FluMist Package Insert (PDF)
- EMEA, Pandemrix Package Insert (PDF)
- EMEA, CHMP Assessment Report for Pandemrix (PDF)
- EMEA, CHMP Assessment Report for Celvapan (PDF)
- GlaxoSmithKline, Arepanix H1N1 (PDF)
- Sanofi Pasteur, Fluzone Indication and Usage
- CDC, CDC's 'What You Need to Know' on 2009 Live Flu Vaccine (PDF)
- CDC, CDC's 'What You Need to Know' on 2009 Inactivated Flu Vaccine (PDF)
- FDA, FDA Approves Vaccines for 2009 H1N1 Influenza Virus
- Novartis, Novartis A(H1N1) Pandemic Influenza vaccine Focetria receives positive opinion from CHMP
- CNSNews.com, FDA Approves New Swine Flu Vaccine
- Drugs.com, Afluria
- Drugs.com, Fluzone
- FDA, Statistical Review and Evaluation-AFLURIA

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Any of various water-soluble compounds capable of turning litmus blue and reacting with an acid to form a salt and water. |
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