Adverse reactions incidence "very common" with GSK's Pandemrix, admits EMEA document
Last Updated on Saturday, 12 September 2009 12:23 Saturday, 12 September 2009 08:59
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An EMEA document reveals that adverse reactions incidence were very common in GlaxoSmithKline's Pandemrix clinical trials.
http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/emea-combined-h832en.pdf
The document says that "nervous system disorders" were "very common".
Musculoskeletal and connective tissue disorders were also very common as were general disorders.
Blood and lymphatic system disorders were also common.
The document also reveals that Pandemrix contains squalene, oil in water adjuvant responsible for the Gulf War Syndrome, in huge doses.
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and
polysorbate 80 (4.86 milligrams).
"No data have been generated in pregnant women with Pandemrix or with any other vaccine that contains the AS03 adjuvant," it says.
"Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1
for more information on mock-up vaccines).
Clinical studies have evaluated the incidence of adverse reactions listed belowin approximately 5,000
subjects 18 years old and above who received formulations containing at least 3.75 microgram
HA/AS03.
Adverse reactions reported are listed according to the following frequency:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders
Common: lymphadenopathy
Psychiatric disorders
Uncommon: insomnia
Nervous system disorders
Very common: headache
Uncommon: paraesthesia, somnolence, dizziness
Gastrointestinal disorders
Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Skin and subcutaneous tissue disorders
Common: ecchymosis at the injection site, sweating increased
Uncommon: pruritus, rash
Musculoskeletal and connective tissue disorders
Very common: arthralgia, myalgia
General disorders and administration site conditions
Very common: induration, swelling, pain and redness at the injection site, fever, fatigue
Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus)
Uncommon: malaise"
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