AS03

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AS03 is the abbreviation for the Adjuvant System 03 , an adjuvant manufactured by the pharmaceutical company GlaxoSmithKline , which is used as an enhancer in vaccines .

It is used in the swine flu vaccine Pandemrix, which is approved in the European Union , to combat the H1N1 2009 pandemic .

AS03 is an oil-in-water emulsion; In Pandemrix, a vaccine dose of 0.5 ml contains 10.69 mg squalene , 11.86 mg DL-α- tocopherol (vitamin E) and 4.86 mg of the emulsifier polysorbate 80 in a phosphate buffer solution . α-Tocopherol serves both as a reducing agent and as an additional immune stimulant. Before use, the emulsion is mixed with the antigen suspension to form the dispersion ready for injection.

AS03 was tested, among other things, as an adjuvant in the pandemic flu vaccine against the influenza A virus H5N1 in a study carried out in Asia. In animal experiments, after injection of pure, non-emulsified squalene, the development of arthritis was observed in a study on rats and the occurrence of certain autoimmune disorders in a study on mice. However, there is a lack of convincing scientific evidence that squalene could cause autoimmune diseases in humans.

The occasional narcolepsy illnesses that occurred after the swine flu vaccination (Pandemrix or, in Canada, Arepanrix) were blamed by some critics on AS03, the suspicion has not yet been confirmed. A plausible pathomechanism has not yet been identified. In narcolepsy cases , the neuropeptide hormone hypocretin is absent , which is associated with the destruction of hypocretin-producing neurons in the area of ​​the hypothalamus . The reason for this is not known, one possible reason could be the relatively high amount of vitamin E in AS03.

Individual evidence

  1. ^ European Medicines Agency (EMEA): EPAR summary for the public: Pandemrix (PDF; 132 kB), accessed November 7, 2012.
  2. ↑ a b c Ralf Wagner and Eberhard Hildt: Composition and mechanisms of action of adjuvants in approved viral vaccines . In: Federal Health Gazette - Health Research - Health Protection . tape 62 , no. 4 , April 1, 2019, p. 462-471 , doi : 10.1007 / s00103-019-02921-1 .
  3. ↑ DW Chu et al .: Immunogenicity and tolerability of an AS03 (A) -adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. In: Vaccine. Volume 27, number 52, December 2009, pp. 7428-7435, doi : 10.1016 / j.vaccine.2009.07.102 , PMID 19683087 .
  4. ^ BC Carlson et al .: The endogenous adjuvant squalene can induce a chronic T-cell-mediated arthritis in rats. In: The American journal of pathology. Volume 156, Number 6, June 2000, pp. 2057-2065, doi : 10.1016 / S0002-9440 (10) 65077-8 , PMID 10854227 , PMC 1850095 (free full text).
  5. ↑ M. Satoh et al .: Induction of lupus autoantibodies by adjuvants. In: Journal of autoimmunity. Volume 21, Number 1, August 2003, pp. 1-9, PMID 12892730 .
  6. ↑ a b Adjuvants: Booster for vaccination. Pharmaceutical newspaper , March 29, 2017, accessed May 22, 2019 .