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AS03 : ウィキペディア英語版
AS03
AS03 (for "Adjuvant System 03") is the trade name for a squalene-based immunologic adjuvant used in various vaccine products by GlaxoSmithKline (GSK). It is used, for example, in GSK's A/H1N1 pandemic flu vaccine Pandemrix. Also in Arepannix and the new Q-pan for H5Ni influenza.
A dose of AS03 adjuvant contains〔(Pandemrix – Summary of product characteristics ), European Medicines Agency website(European Medicines Agency website )〕
* 10.69 mg squalene
* 11.86 mg DL-α-tocopherol
* 4.86 mg polysorbate 80
AS03 is cited as the "likely cause" of dozens of acute narcolepsy cases in Finland.〔(AL: Narkolepsiaa aiheuttaneen rokotteen olisi voinut korvata )〕
There was increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 vaccine. Anaphylaxis after trivalent influenza vaccination is typically reported at a rate of <1 per million doses. In Quebec, Canada, anaphylaxis following administration of the monovalent AS03-adjuvanted H1N1pdm09 vaccine was reported through passive surveillance at a rate of 8 per million doses administered. This was 20 times higher than the reporting rate for non-adjuvanted trivalent vaccines administered during the six previous seasons. However, adequate estimation of the incidence of anaphylaxis is hindered by wide variations in definitions and diagnosis. Summary of paper:
• Quebec passive surveillance showed an increase in anaphylaxis after H1N1pdm09 vaccination.
• Many cases which were reported as other AEFI also met the criteria for anaphylaxis.
• Anaphylaxis was likely underrecognized and its incidence higher than passively observed.
• Incidence of anaphylaxis is estimated at 13 per million doses administered.
• Enhanced public awareness is unlikely to be the predominant explanation for this increase. 〔 ( Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1pdm09) vaccine ) Vaccine 19 Oct 2013 Online 〕
==References==


抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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