Tuesday, 27 October 2009

Swine Flu: Looking More Closely At Pandemrix.- Squalene as an adjuvant

Thinking that the best kind of decision is an informed one, especially when one's health is involved, I like to know what I'm being asked to take into my body, whether that's by way of my digestive system, my nasal membranes or any other route of administration. So, on the matter of these swine flu vaccines, which are being distributed for use in the UK, at a time when it is being reported that swine flu peaked in the middle of October and that, as CBS reports, many cases have been misdiagnosed as swine flu, I want to know what's in them.

For me, not having a background in genetics or biochemistry, the patient information leaflets produced by the manufacturers are written in gobbledy-gook. All I see is lists of things I've either never heard of or have no idea of their function in the vaccine itself or in its production. But, thanks to the wonders of the internet, I can find out. I do wonder, though, if all recipients of the vaccines are given these information leaflets and at what point: some time before, a few days maybe, so that they can read at their leisure; while they are sitting in the queue for the needle; when they are rolling their sleeves back down? The timing would, of course, affect the opportunity to make an informed decision.

So, what's in the vaccines that are being rolled out in the UK? The vaccination programme began last week, with the vaccine being offered initially to those patients considered to be more vulnerable to complications from swine flu itself. The vaccine which will be available to most people is pandemrix from GlaxoSmithKline .

"At the front of the queue are those aged six months to 65 years who have underlying health problems such as asthma. Sky News 21/10/09

Pandemrix from GlaxoSmithKline:

Pandemrix consists of two containers:
Suspension: multidose vial containing the antigen,
Emulsion: multidose vial containing the adjuvant.
Prior to administration, the two components should be mixed.

Active substance:

Split influenza virus, inactivated, containing antigen* equivalent to:
A/California/7/2009 (H1N1)v-like strain (X-179A)
3.75 micrograms** per 0.5 ml dose
* propagated in eggs
** expressed in microgram haemagglutinin

This vaccine complies with the WHO recommendation and EU decision
for the pandemic.

• Adjuvant:
The vaccine contains an ‘adjuvant’ AS03 to stimulate a better response.
This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol
(11.86 milligrams) and polysorbate 80 (4.86 milligrams).

Other ingredients:
The other ingredients are: polysorbate 80, octoxynol 10,
thiomersal, sodium chloride, disodium hydrogen phosphate,
potassium dihydrogen phosphate, potassium chloride,
magnesium chloride, water for injections.

Take special care with Pandemrix:
• if you have had any allergic reaction other than a sudden lifethreatening
allergic reaction to any ingredient contained in the
vaccine, to thiomersal, to egg and chicken protein, ovalbumin,
formaldehyde, gentamicin sulphate (antibiotic) or to sodium
deoxycholate. (see section 6. Further information).

I have highlighted formaldehyde as it is not listed under "Active substances," or, "Other ingredients." Under, Active substances, we have, "Split influenza virus, inactivated, containing antigen." Formaldehyde is the chemical used to split the virus and inactivate it. It is listed under the special care precautions because small traces may remain in the vaccine.

It is well known that formaldehyde is a toxin and much has been written about exposure to high levels of formaldehyde. I have found a great many blogs that insist on the dangers of formaldehyde in vaccines, but I have also found a great many scientific reports which state that the amount of formaldehyde remaining in vaccines is significantly less than in the air we breathe every day, mostly in vehicle exhaust. (Formaldehyde is an intermediate stage in the oxidation or combustion of methane.) However, it may be that formaldehyde entering the body via the abnormal route of injection into deep muscle produces an abnormal immune response.

Thiomersal, (known in the United Sates as thimerosal) under Other ingredients, contains mercury. Opinions differ on the safety of mercury in vaccines.

"Vaccines with mercury have been considered to contribute to autism, learning disabilities, Alzheimer’s Disease, and other neurological conditions, and an FDA review conducted in 1998 determined that, at the time, children who received the full complement of childhood vaccines were potentially exposed to levels of mercury that were sometimes 30 to 50 times the acceptable levels established by the EPA." (Read the full article here)

From the CDC (Centers For Disease Control And Prevention)

"Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930s. There is no convincing scientific evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure."

The adjuvant contains squalene, which is added to stimulate the immune system. When an antigen is introduced into the body via the abnormal route of injection into deep muscle, an abnormal immune response is produced. So, an adjuvant, like squalene is added to produce an intense immune response.

"What squalene does to rats." (Read the entire article here)

"Oil-based vaccination adjuvants like squalene have been proved to generate concentrated, unremitting immune responses over long periods of time.

A 2000 study published in the American Journal of Pathology demonstrated a single injection of the adjuvant squalene into rats triggered “chronic, immune-mediated joint-specific inflammation,” also known as rheumatoid arthritis

"What squalene does to humans." (Mercola.com - as above)

"Your immune system recognizes squalene as an oil molecule native to your body. It is found throughout your nervous system and brain. In fact, you can consume squalene in olive oil and not only will your immune system recognize it, you will also reap the benefits of its antioxidant properties."

"The difference between “good” and “bad” squalene is the route by which it enters your body. Injection is an abnormal route of entry which incites your immune system to attack all the squalene in your body, not just the vaccine adjuvant."

"Your immune system will attempt to destroy the molecule wherever it finds it, including in places where it occurs naturally, and where it is vital to the health of your nervous system."

"Gulf War veterans with Gulf War Syndrome (GWS) received anthrax vaccines which contained squalene.......and has since been linked to the devastating autoimmune diseases suffered by countless Gulf War vets

"Pandemrix has been authorised under “Exceptional Circumstances”.

In other words, it hasn't gone through the usual rigorous testing protocols.

"The European Medicines Agency (EMEA) will regularly review any new information on the medicine and this package leaflet will be updated as necessary."

We'll monitor it as we go along!

When making a decision about whether or not to receive the H1N1, swine flu vaccine, perhaps it should be borne in mind that the vaccine manufacturers have immunity from liability for adverse reactions. This is an extract from a response to a question, under the Freedom of Information Act to the Scottish Chief Medical Officer and Public Health Directorate

"The UK Government, on behalf of the four administrations, signed advance
purchase agreements in June 2007 and accepted liability for the safety
of any vaccines that would be produced as a contingency. All
governments signing up to an advance purchase agreement were expected to
provide an indemnity for the vaccine and neither manufacturer would sign
the contracts without it. The Government's decision was based on the
best procurement and legal advice. Accepting liability in this way is
in line with Government accounting rules and was cleared by the Public
Accounts Committee at the time

The A (H1N1) vaccines that will be used in Scotland and the UK will be
subject to the licensing and regulation requirements for any new
vaccines. We will only use influenza A (H1N1) vaccines if we have
confidence in their safety."

Syed Kerbalai

Read the entire correspondence

We should also bear in mind, that although the above correspondence tells us that the government is accepting liability, that liability is limited to cases where the vaccine is administered in the full knowledge that it may harm. When a vaccine is introduced as a contingency, it has not gone through the normal testing protocol. Therefore, any adverse reaction to something which has not been tested for cannot be a known factor and therefore there is no liability because no intention to harm can be proved.

The above information relating to the ingredients and production of pandemrix is taken from the 2 page patients information leaflet, produced by GlaxoSmithKline. This is the 38 page information leaflet produced by the European Medicines Agency. Note the many instances of, "No data are available," and that the information on testing actually relates mostly to previous vaccines and not to the present H1N1 pandemrix.

Whatever your views about vaccines in general, do you really want to take a vaccine that has not been rigorously tested, against an infection that is said to be on the way out, for which swab testing was suspended in the UK in August this year, because the number of people diagnosed with swine flu was decreasing? Consider the evidence and make an informed decision about this. I will not be accepting the vaccine, but if you do, make sure you know what you are getting. There will be no one to accept liability if your health suffers as a consequence.

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