Gardasil 9: which tox species, and why?

“Toxicology studies supporting the safety of the 9vHPV vaccine included 3 GLP-compliant studies in rats consisting of: i) a repeat-dose toxicity study (with local tolerance and non-GLP immunogenicity assessments), ii) an intramuscular developmental toxicity and immunogenicity study with female fertility and embryo-foetal evaluation and iii) an intramuscular developmental toxicity and immunogenicity study with postnatal evaluation.”

“the 9vHPV vaccine induced humoral immune responses against all 9 HPV serotypes (HPV Type 6, -11, -16, -18, -33, -31, -45, -52, and -58) following one or four intramuscular injections to rats at all dose levels, as a pharmacological effect.”

“The nonclinical toxicology of Gardasil 9 was evaluated in 3 studies, all carried out under GLP-compliant conditions.”

“Toxicology studies supporting the safety of the 9vHPV vaccine included 3 GLP-compliant studies in rats consisting of: i) a repeat-dose toxicity study (with local tolerance and non-GLP immunogenicity assessments), ii) an intramuscular developmental toxicity and immunogenicity study with female fertility and embryo-foetal evaluation and iii) an intramuscular developmental toxicity and immunogenicity study with postnatal evaluation.”

“The reproductive and developmental toxicity of the 9vHPV vaccine was assessed in two GLP-compliant studies using female rats.”

“The oncogenic/carcinogenic potential of the 9vHPV vaccine in long and short-term studies was not evaluated. According to current requirements as mentioned above, carcinogenicity studies are generally not required for vaccines and this is acceptable also for Gardasil 9.”

“The nonclinical toxicology of Gardasil 9 was evaluated in 3 studies, all carried out under GLP-compliant conditions.”