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.[1]

A dose of AS03 adjuvant contains[2]

Concerns/controversy


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:

References

  1. ↑ "FDA panel endorses H5N1 vaccine with adjuvant". 15 Nov 2012.
  2. ↑ Pandemrix – Summary of product characteristics Archived October 7, 2009, at the Wayback Machine., European Medicines Agency websiteEuropean Medicines Agency website
  3. ↑ Increased risk of anaphylaxis following administration of 2009 AS03-adjuvanted monovalent pandemic A/H1N1 (H1N1pdm09) vaccine Vaccine 19 Oct 2013 Online

See also


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