A Similar Nonclinical Safety Evaluation of Prev(e)nar 13 in a Multi-Dose Formulation Containing the Preservative 2-Phenoxyethanol

Together with the other available nonclinical and clinical data of 2-PE and vaccine formulations containing 2-PE and following the 3Rs principle, our risk-assessment-based recommendation is that no additional nonclinical safety studies are needed when evaluating a 2-PE-containing presentation of a previously well-characterized vaccine product if the amount of 2-PE is ≤10 mg/dose.