Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Not conducted for the vaccine (not required for vaccines)
PreHevbrio: genotox, carcinogenicity and repro: done or skipped?
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPs
Genotoxicity
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Carcinogenicity
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
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
GLP rat embryo-fetal and pre/postnatal study: no female reproductive, embryo-fetal or postnatal effects
“There were no female reproductive effects and no effects on fetal/embryonal development and postnatal development up to day 23.”
Safety pharmacology
Not conducted (in line with applicable guidelines)
“The omission of secondary pharmacodynamic and safety pharmacology studies and of the pharmacodynamic drug interaction studies are in line with the applicable regulatory guidelines.”
Genotox: Ames
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Genotox: in vitro mammalian
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Genotox: in vivo
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Carcinogenicity model
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Carcinogenicity timing
Not required (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
hERG / QT
Not conducted (no safety pharmacology studies)
“The omission of secondary pharmacodynamic and safety pharmacology studies and of the pharmacodynamic drug interaction studies are in line with the applicable regulatory guidelines.”
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
Cyfendus
anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)Not conducted
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
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