Shingrix: which tox species, and why?

“Most studies were done in rat and rabbit, as both species demonstrated a good antibody response.”

“Most studies were done in rat and rabbit, as both species demonstrated a good antibody response.”

“Nonclinical studies were performed with the gE/AS01B candidate vaccine formulation, the AS01 adjuvant system and its immunoenhancers QS-21 and MPL.”

“Repeated dose toxicity has thus been evaluated in one relevant animal species (rabbits) and the studies have been conducted according to the relevant WHO and EMA guidelines, including recommendations on dose (full human dose), number of doses (exceeding proposed number in the clinic) and of route of administration (IM is proposed route of administration for licensure).”

“gE/AS01B and AS01B reproductive toxicity was assessed in two studies both performed in rats, one covering pre-, peri- and post-natal development and one covering male fertility.”

“Carcinogenicity studies were not performed. As carcinogenicity studies are not required for final vaccine formulations, adjuvants systems and/or immunoenhancers based on current guidelines, this was considered acceptable.”

“Nonclinical studies were performed with the gE/AS01B candidate vaccine formulation, the AS01 adjuvant system and its immunoenhancers QS-21 and MPL.”