Mosquirix: which tox species, and why?

“As given in the WHO and EMA guidance, rat and rabbit are considered acceptable species for vaccine nonclinical safety studies and therefore generally chosen for the single dose/local tolerance and repeat dose toxicology studies.”

“Serological analysis demonstrated seroconversion in all vaccine treated animals and none in the saline-treated controls, confirming that the rabbit is an immunological responder species for the RTS,S/AS01B candidate vaccine formulation.”

“The tested RTS,S/AS01B formulation consists of 50 μg of RTS,S antigen combined with AS01B containing 50 μg of MPL and 50 μg of QS-21 in liposomes and therefore contains twice the amounts of these constituents than the RTS,S/AS01E (Mosquirix) candidate vaccine.”

“As given in the WHO and EMA guidance, rat and rabbit are considered acceptable species for vaccine nonclinical safety studies and therefore generally chosen for the single dose/local tolerance and repeat dose toxicology studies.”

“and developmental toxicity studies were not included in this Application since the RTS,S/ AS01E candidate vaccine containing, AS01E, MPL, QS-21 is not intended for administration to women of childbearing potential.”

“According to the WHO Guidelines on Nonclinical Evaluation of Vaccines (WHO, 2005), the EMEA Note for Guidance on Preclinical Pharmacological and Toxicological testing of Vaccines (CPMP/SWP/465/95) and the Guideline on adjuvants in vaccines for human use (EMEA/CHMP/VEG/134716/2004), carcinogenicity studies are not required for final vaccine formulations, Adjuvants Systems and/or immunoenhancers.”

“The tested RTS,S/AS01B formulation consists of 50 μg of RTS,S antigen combined with AS01B containing 50 μg of MPL and 50 μg of QS-21 in liposomes and therefore contains twice the amounts of these constituents than the RTS,S/AS01E (Mosquirix) candidate vaccine.”