Tuesday, September 15, 2009

H1N1 "Swine Flu" Vaccine Package Inserts (GSK, CSL, Novaris, Sanofi & MedImmune)



Above, a doctor retracts his H1N1 vaccine recommendation after reading the package inserts.

**UPDATE (11/11/2009) - The FDA just approved GlaxoSmithKline's FLULAVAL®. There are now five (5) vaccine makers in the United States. FLULAVAL® contains thimerosal and formaldehyde among its ingredients. The link to the package insert is listed below.

**

Hot off of the presses are the latest FDA package inserts for the five (5) four (4) H1N1 "swine flu" vaccines. If you have been following the action on this blog, you will recall that Remixx World! compiled the ingredients from many different mainstream media sources and remixed it into a nice compilation article listing the vaccine's ingredients. That previous blog article has been confirmed based on the ingredients listed in Section 11 of the below package inserts for the five (5) four (4) approved H1N1 "swine flu" vaccines.

List of the FDA's Influenza A (H1N1) 2009 Monovalent Vaccine Approved Products (5 package inserts)

1. Influenza A (H1N1) 2009 Monovalent Vaccine: Manufactured by CSL Limited

Influenza A (H1N1) 2009 Monovalent 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. Influenza A (H1N1) 2009 Monovalent Vaccine 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 a continuous flow zonal centrifuge. 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.

Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg HA per 0.5 mL dose of influenza A/California/7/2009 (H1N1)v-like virus.


The single-dose formulation is preservative-free; thimerosal, a mercury derivative, is not used in the manufacturing process for this formulation. The multi-dose formulation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.


A single 0.5 mL dose of Influenza A (H1N1) 2009 Monovalent Vaccine 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 dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (≤ 1 mcg), neomycin sulfate (≤ 0.2 picograms [pg]), polymyxin B (≤ 0.03 pg), and beta-propiolactone.

2. Influenza A (H1N1) 2009 Monovalent Vaccine: Manufactured by Novartis Vaccines and Diagnostics Ltd.

3. Influenza A (H1N1) 2009 Monovalent Vaccine: Manufactured by Sanofi Pasteur Inc.
Initial US Approval: 1980

1980???????? Can someone please explain this one to me? If the H1N1 swine flu just popped up back in April, then how could there be a US approval in 1980? Is 1980 perhaps the year that Sanofi Pasteur gained approval for its very first product? I know there's some brainiac out there who can explain it.

4. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal: Manufactured by MedImmune, LLC

5. Influenza A (H1N1) 2009 Monovalent Vaccine: Manufactured by ID Biomedical Corporation of Quebec a/k/a FLULAVAL®


6 comments:

Kim W. said...

Knowing a bit of history will help explain the 1980 approval. In 1976 the U.S. army had an outbreak of the H1N1 virus at Fort Dix. Thankfully it did not spread. At that time the president and health officals decided it was necessary to create a vaccine to prevent an epidemic. The initial trial vaccines were met with scepticism and fear when they caused some cases of Guillian-Barre syndrome. A vaccine was later approved in 1980.

The Moderator said...

Thanks for that information Kim. So does that mean this vaccine will not be effective against the H1N1? The 1976 swine flu and the H1N1 swine flu are different strains, so would this vaccine developed in 1980 be effective against an H1N1 virus that was only first created in the last few years?

Unknown said...

After reading the recent Nov 2009 article in the Atlantic Magazine entitled "Shot in the Dark", my suspicions were confirmed that the efficacy of many vaccination programs have been given undue respect as being safe and effective means to manage flu epidemics.

Coincidentally, this weeks news (Oct 2009) showed "best profits ever" for many of these vaccine manufacturers. Very hard not to be a skeptic on what is driving the sale of these products (un-proven vaccine technology) "sold" to the government and "sold"to us)using scare tactics.

Just show me bonafide studies showing real and safe effectiveness of these programs,
or stop wasting limited government resources. Wash your hands, avoid crowds. Avoid sick people. Eat healthy and fresh food. Take your vitamins. Exercise and Rest.

But of course there is no money it that!

Don in Davis, Ca.

Unknown said...

I heard there's shark oil in this vaccine. Is this true? I'm VERY allergic. If there is, I can't get vaccinated. Does anyone know? Thanks.

The Moderator said...

@Jill, I believe that any shark liver oil will be contained in the squalene adjuvant ingredient, if any, in the vaccine. Supposedly, the U.S. H1N1 swine flu vaccines do not contain squalene adjuvants at this time. However, the Pandemrix vaccine in Europe will contain squalene (http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/Pandemrix-PU-17-en.pdf). Squalene can contain shark liver oil (http://www.vitasprings.com/squalene-shark-liver-oil.html). If you decide to get the vaccine, check with your medical professional and the vaccine package insert before you get the injection, and see if the vaccine contains squalene, then find out whether or not the squalene in the vaccine contains shark liver oil.

Unknown said...

Thanks so much for your answer and advice. I recently discovered that yes, it is in the adjuvant and most of the protein is removed thus there are minimal cases of allergic reactions in seafood allergic persons. I am still going to speak to my doctor about this. Thank you so much. I appreciate it.