Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Not conducted for the vaccine (not required for vaccines)
Flublok: genotox, carcinogenicity and repro: done or skipped?
influenza vaccine, recombinant hemagglutinin · Influenza HA
Genotoxicity
Not conducted (not normally required for viral vaccines; no adjuvant)
“No genotoxicity and carcinogenicity studies were carried out in line with relevant guidelines. Studies evaluating genotoxicity and carcinogenicity are normally not required for viral vaccines.”
Carcinogenicity
Not conducted (not normally required for viral vaccines; no adjuvant or novel excipients)
“Studies evaluating genotoxicity and carcinogenicity are normally not required for viral vaccines. Since no adjuvants or novel excipients are used in this product absence of those studies is considered acceptable.”
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 fertility, embryo-fetal and early postnatal study (three IM doses, pre-mating and GD6): no adverse effects
“In DART study conducted in female rats, three IM injections (31 and 12 days before mating and on Gestation Day 6) of RIV3 did not induce maternal toxicity, and there were no adverse effects on mating performance or fertility, embryo-foetal development (including an evaluation of teratogenicity) and an early post-natal development.”
Safety pharmacology
Dedicated single-dose SC studies: dog cardiovascular, rat respiratory and CNS; no effects
“Results of safety pharmacology studies showed that a single SC injection with RIV3 did not adversely affect the blood pressure, heart rate, ECG parameters (in beagle dogs), respiratory parameters (in rats) as well as FOB, locomotor activity or body temperature (in rats).”
Genotox: Ames
Not conducted (not normally required for viral vaccines)
“No genotoxicity and carcinogenicity studies were carried out in line with relevant guidelines. Studies evaluating genotoxicity and carcinogenicity are normally not required for viral vaccines.”
Genotox: in vitro mammalian
Not conducted (not normally required for viral vaccines)
“No genotoxicity and carcinogenicity studies were carried out in line with relevant guidelines. Studies evaluating genotoxicity and carcinogenicity are normally not required for viral vaccines.”
Genotox: in vivo
Not conducted (not normally required for viral vaccines)
“No genotoxicity and carcinogenicity studies were carried out in line with relevant guidelines. Studies evaluating genotoxicity and carcinogenicity are normally not required for viral vaccines.”
Carcinogenicity model
Not conducted (not normally required for viral vaccines; no adjuvant or novel excipients)
“Studies evaluating genotoxicity and carcinogenicity are normally not required for viral vaccines. Since no adjuvants or novel excipients are used in this product absence of those studies is considered acceptable.”
Carcinogenicity timing
Not required: viral vaccine without adjuvant or novel excipients
“Studies evaluating genotoxicity and carcinogenicity are normally not required for viral vaccines. Since no adjuvants or novel excipients are used in this product absence of those studies is considered acceptable.”
hERG / QT
Single SC dose in beagle dogs: no effect on blood pressure, heart rate or ECG
“Results of safety pharmacology studies showed that a single SC injection with RIV3 did not adversely affect the blood pressure, heart rate, ECG parameters (in beagle dogs), respiratory parameters (in rats) as well as FOB, locomotor activity or body temperature (in rats).”
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
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