Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Not conducted for the vaccine (not required for vaccines)
Fendrix: genotox, carcinogenicity and repro: done or skipped?
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)
Genotoxicity
MPL only: negative in Ames and CHO clastogenicity tests; vaccine not tested
“An in vitro mutagenicity (Ames) and clastogenicity (CHO cells) test failed to demonstrate a genotoxic potential of MPL.”
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 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
Rabbit teratogenicity and rat pre/postnatal studies: no maternal toxicity, teratogenicity or F1 developmental effects
“Reproductive toxicity studies including a teratogenicity study in the rabbit and a pre-and postnatal study in the rat showed no evidence of maternal toxicity, teratogenicity or any effect on the in utero development of the F1 offspring.”
Safety pharmacology
Dedicated study: no respiratory or cardiovascular effects up to 63-fold the human dose (bodyweight basis)
“A safety pharmacology study did not show any effect on respiratory or cardiovascular parameters when the HBsAg was administered intravenously or when the HB-AS04C vaccine was given intramuscularly, up to a 63-fold of the human dose expressed on a bodyweight basis.”
Genotox: Ames
MPL negative in Ames test
“An in vitro mutagenicity (Ames) and clastogenicity (CHO cells) test failed to demonstrate a genotoxic potential of MPL.”
Genotox: in vitro mammalian
MPL negative in CHO cell clastogenicity test
“An in vitro mutagenicity (Ames) and clastogenicity (CHO cells) test failed to demonstrate a genotoxic potential of MPL.”
Genotox: in vivo
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.
Carcinogenicity model
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.
Carcinogenicity timing
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.
hERG / QT
No cardiovascular or respiratory effects in safety pharmacology study up to 63-fold the human dose; no hERG assay
“A safety pharmacology study did not show any effect on respiratory or cardiovascular parameters when the HBsAg was administered intravenously or when the HB-AS04C vaccine was given intramuscularly, up to a 63-fold of the human dose expressed on a bodyweight basis.”
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
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