Flublok: which tox species, and why?

“The pivotal repeat-dose toxicity study was conducted with the SC route. Results showed that five weekly SC injections with RIV3 were locally and systemically well tolerated in rats.”

“RIV3 at the human dose induced an active immune response to the three strains in all rat dams from the vaccine group. The exposure of foetuses and pups to vaccine-specific maternal antibodies was also demonstrated.”

“No non-clinical toxicity studies have been performed with RIV4. The applicant supports the non-clinical safety evaluation of RIV4 based on a number of toxicology studies conducted with RIV3.”

“The pivotal repeat-dose toxicity study was conducted with the SC route. Results showed that five weekly SC injections with RIV3 were locally and systemically well tolerated in rats.”

“In DART study conducted in female rats, three IM injections (31 and 12 days before mating and on Gestation Day 6) of RIV3 did not induce maternal toxicity, and there were no adverse effects on mating performance or fertility, embryo-foetal development (including an evaluation of teratogenicity) and an early post-natal development.”

“No genotoxicity and carcinogenicity studies were carried out in line with relevant guidelines. Studies evaluating genotoxicity and carcinogenicity are normally not required for viral vaccines.”

“No non-clinical toxicity studies have been performed with RIV4. The applicant supports the non-clinical safety evaluation of RIV4 based on a number of toxicology studies conducted with RIV3.”