Pandemrix Vaccine

Content:  Influenza-virus, inactivated containing an antigen in accordance with the following:

A/California/7/2009 (H1N1) like strain (X-179A) 3.75 microgram**
* bred in eggs
** Haemaglutinin

Additives: AS03 as adjuvants, consisting of squalen (10.69 milligram), DL-α-tocopherol (11.86 milligram) and polysorbate 80 (4.86 milligram) (please refer also to swine flu vaccines)

Other compounds: The vaccine contains 5 microgram thimerosal

After mixing the suspension (antigen) and the emulsion (adjuvants) the vaccine is available in a multi-container bottle.

Injection bottle with suspension:
Polysorbat 80
Octoxynol 10
Thimerosal
Sodium chloride (NaCl)
Sodium monohydrogen phosphate (Na2HPO4)
Sodium dihydrogen phosphate (KH2PO4)
Sodium chloride (KCl)
Magnesium chloride (MgCl2)
Water for injection purposes

Injection bottle with emulsion:
Sodium chloride (NaCl)
Sodium monohydrogen phosphate (Na2HPO4)
Sodium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Water for injection purposes

For the sample approval a H5N1 virus strain was used which was replaced by the H1N1 strain.

Pandemrix adverse effects:

The reported adverse effects are listed according to the following frequencies:

Very frequent (≥1/10)
Frequent (≥1/100 to <1/10)
Occasional (≥1/1.000 to <1/100) 
Rare (≥1/10.000 to <1/1.000)
Very rare (<1/10.000)

Diseases of the blood and the lymph system

Frequent: Lymph adenopathia

Psychiatric diseases

Frequent: insomnia

Diseases of the nervous system

Very frequent: headaches

Occasional:  Paraesthesia, dazedness, dizziness

Diseases of the gastrointestinal tract

Occasional: Gastrointestinal symptoms (such as diarrhea, vomiting, abdominal pain, nausea)

Diseases of the skin and subcutaneous tissue

Frequent: Bleeding of the skin at the site of injection, more sweat secretion than usual

Occasional: itchiness, skin rash

Diseases of the muscles of the skeleton-, tissue and bones

Very frequent:  Arthralgia,  myalgia

General diseases and problems at the site of injection

Very frequent: Hardening, pain and redness at the injection site, fever, fatigue

Frequent: Chills, flu-like diseases, reactions at the site of injection (such as heat and itchiness)

Occasional: Nausea

Experiences that users have after market introduction

There is no data that pertains to the use of Pandemrix.

There were reports of the following side effects during the application and after the market introduction of interpandemic (seasonal) trivalent vaccines:

Occasional: General skin reactions including urticaria

Rare: Neuralgia, seizures, temporary thrombocytopenia.
There were reports of allergic reactions which in rare cases led to shock.

Very rare: Vasculitis with temporary renal involvement.
Neurological diseases such as encephalomyelitis, neuritis and Guillain-Barré-Syndrome

Pandemrix contains thimerosal (an organic compound which contains mercury) as a means to conserve. Therefore there can be sensitive reactions.

Conclusion:

Due to the short duration of the trial and the minimal size of the trials the above-mentioned adverse effects are to be taken with extreme caution. Severe rare side effects were not recorded here. Also side effects (mainly autoimmune diseases) due to squalen, which generally do not occur until weeks or months after the vaccination, are missing in the above list.

This preservative is very risky mainly for pregnant women and small children. The effect of thimerosal is neurotoxic and can damage an unborn child.

A rare trial that was conducted by BUND (Mercury Global negative Impact and Endangerment of children’s abilities) contains the following description of mercury:

Recently the leading scientific institution for the investigation of neurological development of children warned that children who were subjected to even minute amounts of mercury could suffer brain drain. According to Professor Philippe Grandjean of Harvard University and the University of South Denmark our society is suffering from a gradual loss of intelligence: Chemicals are reducing the average IQ of our population. The generally irreversible damage for adolescent brains is due to their being subjected to mercury and other toxins which hinder  the early development stages in much smaller amounts that hitherto assumed. The population groups that are at greatest risk are newborns, small children and pregnant women. Mercury is particularly poisonous for the developing central nervous system: it is enriched in the human body and is transferred to the fetus during pregnancy. Pregnant women or women who will have children at a later stage can therefore unknowingly subject the fetus to the risk of obtaining serious brain damage. (http://www.env-health.org/IMG/pdf/quecksilber_studie_032007.pdf)

This is another quote from the trial:

„It is a generally accepted fact that a mother’s being subjected to methyl mercury can influence the development of the nervous system of her unborn child. What however is being discussed is the extent of the environmental burden with mercury which has been proven to cause this damage. Over the course of time we have improved technology and we are capable of proving damages at an ever lower level. It is probable that a scientific consensus will be found that there is no dose of mercury that does not endanger a fetus.”
(Peter Orris, MD, MPH, FACP; FACOEM, Professor for Public Health at the University of Illinois in Chicago)

Borderline values for the daily exposure to mercury differ according to each institution. The US National Research Council (NRC) has lower threshold values as the WHO. The NRC lists the threshold value for methyl mercury (a different mercury compound) as being 0.1 μg/kg bodyweight/day, the WHO on the other hand at 0.22 μg/kg bodyweight/day.
This value, however, is for oral consumption. (The oral bioavailability of organ mercury compounds is 50-100%). A threshold value for the application by injection has not been defined yet. However it is presumably much lower.