ECHA | Sanofi Pasteur Opinion Adopted for 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated

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Broad information on use applied for: Sanofi Pasteur produces seasonal influenza vaccines that protect the public against either three or four strains of influenza as well as single strain vaccines when an influenza pandemic occurs. The production of Sanofi Pasteur’s seasonal influenza vaccines takes place at Val de Reuil, France. Production at the facility shifts to pandemic vaccines when the need arises.

During production, Octoxynol-9 is an essential component used to split the influenza virus and recover the viral antigens that are the main ingredients of the vaccines. The virus splitting step uses Octoxynol-9 at a concentration of 0.5% (v/v). Virus splitting also contributes to virus inactivation because split viruses are not infectious anymore. Additional virus inactivation steps are also needed to meet safety standards from health authorities, including treatment with other substances. Part of the Octoxynol-9 is then removed from the harvested medium in the following filtration steps. The remaining Octoxynol-9 intentionally present in the vaccine contributes to the stabilization of the viral antigens in the final vaccine, preserving these and thus ensuring its potency and efficacy. The final vaccine product is formulated with additional components necessary for its administration and is then filled into a syringe or a vial, checked for quality and packaged for distribution.



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