# AS03

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{{Short description|Vaccine ingredient}}
'''AS03''' (for "Adjuvant System 03") is the trade name for a [squalene](/source/squalene)-based [immunologic adjuvant](/source/immunologic_adjuvant) used in various vaccine products by [GlaxoSmithKline](/source/GlaxoSmithKline) (GSK). It is used, for example, in GSK's [A/H1N1](/source/A%2FH1N1) [pandemic flu](/source/pandemic_flu) vaccine [Pandemrix](/source/Pandemrix). It is also in Arepanrix and the Q-pan for H5N1 influenza.<ref name=Q-Pan>{{cite news |url=http://www.cidrap.umn.edu/cidrap/content/influenza/panflu/news/nov1512vrbpac.html |title=FDA panel endorses H5N1 vaccine with adjuvant |date=15 Nov 2012}}</ref> A dose of AS03 adjuvant contains<ref name="emea">[http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/emea-combined-h832en.pdf Pandemrix – Summary of product characteristics] {{webarchive|url=https://web.archive.org/web/20091007191040/http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/emea-combined-h832en.pdf |date=October 7, 2009 }}, [European Medicines Agency](/source/European_Medicines_Agency) website[http://www.emea.europa.eu/ European Medicines Agency website] {{Webarchive|url=https://web.archive.org/web/20130715075412/http://www.emea.europa.eu/ |date=2013-07-15 }}</ref>
* 10.69&nbsp;mg [squalene](/source/squalene)
* 11.86&nbsp;mg DL-[α-tocopherol](/source/%CE%B1-tocopherol)
* 4.86&nbsp;mg [polysorbate 80](/source/polysorbate_80)

In the [2009 influenza pandemic](/source/2009_influenza_pandemic), vaccines containing AS03 delivered a stronger immunogene response against pandemic [H1N1 influenza](/source/H1N1_influenza) than non-adjuvanted vaccines, despite their containing lower levels of viral [antigen](/source/antigen).<ref name="Yin2011">{{cite journal |vauthors=Yin JK, Khandaker G, Rashid H, Heron L, Ridda I, Booy R |title=Immunogenicity and safety of pandemic influenza A (H1N1) 2009 vaccine: systematic review and meta-analysis |journal=Influenza and Other Respiratory Viruses |date=September 2011 |volume=5 |issue=5 |pages=299–305 |doi=10.1111/j.1750-2659.2011.00229.x |pmid=21668694 |url= |pmc=4986623}}</ref>

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](/source/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.<ref name=Ahmed2016rev>{{cite journal|last1=Ahmed|first1=SS|last2=Montomoli|first2=E|last3=Pasini|first3=FL|last4=Steinman|first4=L|title=The Safety of Adjuvanted Vaccines Revisited: Vaccine-Induced Narcolepsy.|journal=The Israel Medical Association Journal|date=2016|volume=18|issue=3–4|pages=216–20|pmid=27228647|url=https://www.ima.org.il/FilesUpload/IMAJ/0/193/96921.pdf}}</ref>  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, or combinations of these factors.<ref name=Ahmed2016rev/>

==See also==
* [2009 flu pandemic](/source/2009_flu_pandemic)
* [MF59](/source/MF59) – another squalene-based adjuvant by Novartis
* [AS04](/source/AS04) – another adjuvant by GSK
==References==
{{reflist}}

Category:Adjuvants

{{vaccine-stub}}

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