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
Arexvy: genotox, carcinogenicity and repro: done or skipped?
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)
Genotoxicity
Not conducted for the vaccine (not required for vaccines)
“The absence of genotoxicity studies is accepted. This is not required for vaccines.”
Carcinogenicity
Not conducted (not required for vaccines)
“The absence of carcinogenicity studies is accepted and not required for vaccines.”
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 (RSVPreF3; RSVPreF3/AS01E) and rat (RSVPreF3) DART: no effects on female fertility, embryo-fetal or pre/postnatal development
“In addition, the report from a DART study with the complete product (i.e., RSVPreF3/AS01E; full human dose, 120 μg PreF3) in rabbit was provided. In neither of the studies effects were observed on female fertility, embryo-foetal, pre- and postnatal development.”
Safety pharmacology
No dedicated studies for the vaccine (endorsed); AS01E components MPL and QS-21 evaluated in three safety pharmacology studies
“In addition, the AS01E adjuvant components (i.e., MPL, QS21) were evaluated in three safety pharmacology studies, ten general toxicology studies, ten genotoxicology studies, five reproductive toxicology studies, and three local tolerance studies.”
Genotox: Ames
Not conducted for the vaccine (not required for vaccines)
“The absence of genotoxicity studies is accepted. This is not required for vaccines.”
Genotox: in vitro mammalian
Not conducted for the vaccine (not required for vaccines)
“The absence of genotoxicity studies is accepted. This is not required for vaccines.”
Genotox: in vivo
Rat micronucleus test of test formulations: no micronuclei; one IM formulation caused bone marrow cell toxicity
“IV1, IM1 and IM2 did not show any evidence of causing chromosome damage or bone marrow cell toxicity in this in vivo test procedure. IM3 showed no evidence of causing micronuclei but did show evidence of causing bone marrow cell toxicity in this in vivo test procedure.”
Carcinogenicity model
Not conducted (not required for vaccines)
“The absence of carcinogenicity studies is accepted and not required for vaccines.”
Carcinogenicity timing
Not required for vaccines
“The absence of carcinogenicity studies is accepted and not required for vaccines.”
hERG / QT
Not conducted (no dedicated safety pharmacology studies)
“The absence of dedicated safety PD studies can be endorsed.”
Same question, other vaccines
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
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