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 H5N1 influenza.[1]
A dose of AS03 adjuvant contains[2]
- 10.69 mg squalene
- 11.86 mg DL-α-tocopherol
- 4.86 mg polysorbate 80
Small observational studies reported from Finland and Sweden in 2012, and larger studies from Ireland reported in 2012, and reported in each of England, Norway and France in 2013, found an association between narcolepsy and an A(H1N1)pdm09 vaccine that used AS03 adjuvant; the rates ranged from one in 16,000 doses to one in 50,000 doses.[3] As of 2016 it was unclear whether or not the adjuvant was responsible; other suspected causes include genetic susceptibility, exposure to A(H1N1)pdm09, manufacturing impurities, and combinations of these factors.[3]
References
- ^ "FDA panel endorses H5N1 vaccine with adjuvant". 15 Nov 2012.
- ^ Pandemrix – Summary of product characteristics Archived October 7, 2009, at the Wayback Machine, European Medicines Agency websiteEuropean Medicines Agency website
- ^ a b Ahmed, SS; Montomoli, E; Pasini, FL; Steinman, L (2016). "The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy" (PDF). The Israel Medical Association journal : IMAJ. 18 (3–4): 216–20. PMID 27228647.
See also
- 2009 flu pandemic
- MF59 – another squalene-based adjuvant by Novartis
- AS04 – another adjuvant by GSK
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