Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Not conducted for the vaccine (not required for vaccines)
Cyfendus: genotox, carcinogenicity and repro: done or skipped?
anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)
Genotoxicity
Not conducted
“CYFENDUS has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals.”
Carcinogenicity
Not conducted
“CYFENDUS has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals.”
Instead of carcinogenicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Instead of genotoxicity
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
DRG histopathology
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Reproductive & developmental
Rat DART study: no effects on mating, fertility, pregnancy, embryo-fetal viability or postnatal survival and development
“No reproductive or developmental toxicity was noted in the DART study. There was no effect on mating, fertility, pregnancy, embryo-fetal viability, growth, or morphologic development, parturition, maternal care of offspring or postnatal survival, growth, or development.”
Safety pharmacology
Covered by repeat-dose clinical observations: no effects of CpG 7909 or the vaccine
“Treatment with adjuvant CPG 7909 or CPG 7909 combined with AVA (AV7909) had no effect on cage-side, clinical, or dermal Draize observations.”
Genotox: Ames
Not conducted
“CYFENDUS has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals.”
Genotox: in vitro mammalian
Not conducted
“CYFENDUS has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals.”
Genotox: in vivo
Not conducted
“CYFENDUS has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals.”
Carcinogenicity model
Not conducted
“CYFENDUS has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals.”
Carcinogenicity timing
Not evaluated for carcinogenicity in animals
“CYFENDUS has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals.”
hERG / QT
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Same question, other vaccines
Cervarix
human papillomavirus bivalent (types 16, 18) vaccine, recombinant, AS04-adjuvanted · HPV 16/18 L1 VLPs; TLR4 (AS04 adjuvant)Vaccine not tested; MPL adjuvant negative in Ames, CHO clastogenicity and in vivo micronucleus
Fendrix
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)MPL only: negative in Ames and CHO clastogenicity tests; vaccine not tested
Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HANot conducted (not normally required for viral vaccines; no adjuvant)
Gardasil
human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPsNot conducted (CPMP/SWP/465/95 vaccine guidance)
Gardasil 9
human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPsNot conducted (vaccine guidance; CHMP agreed)
Heplisav-B
hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)CpG adjuvant negative in Ames, in vitro chromosome aberration and in vivo mouse micronucleus tests
Mosquirix
RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)Not conducted on the final vaccine; adjuvant system components tested instead
Nuvaxovid
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)Matrix-M1 adjuvant negative in GLP Ames and in vitro CHO micronucleus assays; in vivo testing judged unnecessary
PreHevbrio
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPsNot conducted (in line with applicable guidelines)
Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)Not conducted on the final vaccine formulation (considered acceptable)
HBVaxPro
hepatitis B vaccine (rDNA) · HBsAg VLPsNot stated in public reviews