title: Regulatory considerations for new stabilised poliovaccines.
abstract: As the least heat stable vaccine used by national immunization programmes, oral poliovaccine (OPV) is a target for improved stability. Dilution of OPV trivalent bulk vaccines meeting all international requirements in 87% deuterium oxide results in a significant stability increase of up to 1000-fold after incubation for one week at 45 degrees C. Regulatory considerations for a new formulation focus generally on the safety, potency and efficacy of the individual components (OPV and deuterium oxide) and ruling out any untoward and unexpected interactions between them. As the characteristics of OPV and deuterium oxide are well established, preclinical and clinica, data should address potential interactions. Because this stabilised vaccine is under development by two European manufacturers, initial regulatory discussions are being conducted with the European Medicines Evaluation Agency and its Committee on Proprietary Medicinal Products.
authors.affiliation: Global Programme for Vaccines and Immunization, World Health Organization, Geneva, Switzerland.
authors.forename: J B
authors.initials: JB
authors.lastname: Milstien
authors.forename: S
authors.initials: S
authors.lastname: Lemon
mesh_terms: D002675:Child, Preschool; D002986:Clinical Trials as Topic; D017666:Deuterium Oxide / Q000009:adverse effects / Q000494:pharmacology; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D006860:Hydrogen Bonding / Q000187:drug effects; D007223:Infant; D017955:Poliovirus / Q000187:drug effects / Q000472:pathogenicity / Q000502:physiology; D011055:Poliovirus Vaccine, Oral / Q000737:chemistry / Q000592:standards*; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000494:pharmacology; D012449:Safety; D013696:Temperature; D013997:Time Factors; D014944:World Health Organization
chemical_list: D011055:Poliovirus Vaccine, Oral; D011310:Preservatives, Pharmaceutical; D017666:Deuterium Oxide