Reproductive XXXX testing of vaccines.

@entity1 @entity137 @entity2348 @entity95 @entity600 @entity18186 @entity281
@entity18186 play a major role in the prevention of @entity1 @entity600 by protecting the pregnant @entity1 from teratogenic or otherwise harmful infections. Until now, it has not been common practice to perform preclinical developmental @entity137 tests for new vaccines. Despite the excellent safety record of vaccines, increased attention is now being given to the feasibility of screening new vaccines for developmental hazards in animals before their use in @entity1 . Contrary to previous assumptions, many vaccines are now given to potentially pregnant @entity1 . Any new components of the vaccine formulation (adjuvants, excipients, stabilisers, preservatives, etc.) could also be tested for influences on development, although based on past experience the risks are limited by the very low dosages used. The conferred immunity following vaccination lasts for several years. Therefore, the developing conceptus may theoretically be exposed to the induced antibodies and/or sensitised T-cells, even if the pregnant @entity1 was last vaccinated during childhood (particularly if she encounters the antigen during pregnancy through exposure to @entity281 ). However, it should be kept in mind that viral or @entity2348 represent a higher risk for a pregnant @entity1 than the potential adverse effects related to vaccination or the associated immune response. Non-clinical safety studies may be employed as an aid for hazard identification. In these studies interactions of the vaccine with the maternal immune system or with the developmental systems of the offspring are considered. Post-natal examinations are necessary to detect all possible manifestations of developmental @entity137 , such as effects on the immune system. Species selection for the preclinical studies is based on immunogenicity to the vaccine and the relative timing and rate of transfer of maternal antibodies to the offspring. A single study design is proposed for the pre- and post-natal developmental assessments of vaccines in rodents and @entity95 .
