Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Not conducted for the vaccine (not required for vaccines)
Gardasil: genotox, carcinogenicity and repro: done or skipped?
human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPs
Genotoxicity
Not conducted (CPMP/SWP/465/95 vaccine guidance)
“No genotoxicity studies were conducted, and this is in line with CPMP/SWP/465/95.”
Carcinogenicity
Not conducted (CPMP/SWP/465/95 vaccine guidance)
“No carcinogenicity studies were conducted, and this is in line with CPMP/SWP/465/95.”
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
Female rat study covering all phases of reproduction and development; maternal antibodies transferred to offspring
“The reproductive and developmental toxicity was assessed in a study in female Sprague-Dawley rats addressing all phases of reproduction and foetal development. An immune response to the vaccine was observed, and antibodies were shown to be transferred to the offspring during gestation and also lactation.”
Safety pharmacology
Not performed; physical signs monitored in toxicity studies (vaccine guidance)
“Safety pharmacology studies were not performed. However in the toxicological studies safety daily monitoring for physical signs did not reveal any notable respiratory problems. This approach is in accordance with Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95).”
Genotox: Ames
Not conducted (vaccine guidance)
“No genotoxicity studies were conducted, and this is in line with CPMP/SWP/465/95.”
Genotox: in vitro mammalian
Not conducted (vaccine guidance)
“No genotoxicity studies were conducted, and this is in line with CPMP/SWP/465/95.”
Genotox: in vivo
Not conducted (vaccine guidance)
“No genotoxicity studies were conducted, and this is in line with CPMP/SWP/465/95.”
Carcinogenicity model
Not conducted (CPMP/SWP/465/95 vaccine guidance)
“No carcinogenicity studies were conducted, and this is in line with CPMP/SWP/465/95.”
Carcinogenicity timing
Not required under vaccine guidance (CPMP/SWP/465/95)
“No carcinogenicity studies were conducted, and this is in line with CPMP/SWP/465/95.”
hERG / QT
Safety pharmacology not performed; no notable respiratory findings in toxicity studies
“Safety pharmacology studies were not performed. However in the toxicological studies safety daily monitoring for physical signs did not reveal any notable respiratory problems. This approach is in accordance with Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95).”
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 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