Gardasil: which tox species, and why?

“A 10-week repeat-dose toxicity study was performed in BALB/c mice.”

“In both exploratory studies, it was demonstrated that the vaccine was immunogenic in rats and that an anti-HPV antibody response was seen for each HPV type present in the vaccine. These results show that the rat is an appropriate animal model for investigating the potential toxic effects related to administration of Gardasil.”

“The monovalent L1 VLP and quadrivalent Gardasil vaccine formulations tested in these studies were made by the same manufacturing process as the GMP lots and are, therefore, similar to lots that were used in the clinic.”

“A 10-week repeat-dose toxicity study was performed in BALB/c mice.”

“The reproductive and developmental toxicity was assessed in a study in female Sprague-Dawley rats addressing all phases of reproduction and foetal development. An immune response to the vaccine was observed, and antibodies were shown to be transferred to the offspring during gestation and also lactation.”

“No carcinogenicity studies were conducted, and this is in line with CPMP/SWP/465/95.”

“These studies with species-specific papillomaviruses have demonstrated the possibility to vaccinate against infection and development of tumour lesions using virus-like particles formed by recombinant viral capsid proteins (Breitburd et al 1995, Jansen et al 1995, Suzich et al 1995) and have been used as models for vaccine development.”