Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Rabbit (repeat-dose toxicity, DART) and rat (DART); mice for immunogenicity only
Fendrix: which tox species, and why?
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)
Species
Rabbit (repeat-dose toxicity of the vaccine)
“Serological analysis demonstrated that unlike controls or adjuvant receiving animals, vaccine-treated rabbits showed a seroconversion in the repeat-dose toxicity study.”
Why that species
No explicit rationale; rabbits seroconverted to the vaccine in the repeat-dose study
“Serological analysis demonstrated that unlike controls or adjuvant receiving animals, vaccine-treated rabbits showed a seroconversion in the repeat-dose toxicity study.”
Surrogate molecule
No surrogate; clinical HB-AS04C vaccine and adjuvant tested in rabbit
“Serological analysis demonstrated that unlike controls or adjuvant receiving animals, vaccine-treated rabbits showed a seroconversion in the repeat-dose toxicity study.”
Species: general tox
Rabbit (vaccine, intramuscular repeat-dose)
“Observation of local tolerance in the repeat-dose toxicity study with intramuscular administration in rabbits pointed to minor reactions at the injection sites characterized by an inflammatory reaction with mixed-cell or mononuclear cell infiltrate, which disappeared one month after the last injection.”
Species: DART
Rabbit (teratogenicity) and rat (pre- and postnatal development)
“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.”
Species: 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.
Surrogate used in
No surrogate used
“Serological analysis demonstrated that unlike controls or adjuvant receiving animals, vaccine-treated rabbits showed a seroconversion in the repeat-dose toxicity study.”
Same question, other vaccines
Cervarix
human papillomavirus bivalent (types 16, 18) vaccine, recombinant, AS04-adjuvanted · HPV 16/18 L1 VLPs; TLR4 (AS04 adjuvant)Rabbit (four repeat-dose studies) and rat (one repeat-dose, DART, safety pharmacology); dog for MPL alone
Cyfendus
anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)Rat only
Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HARat only for repeat-dose toxicity and DART (trivalent RIV3); dog and rat for safety pharmacology
Gardasil
human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPsMouse (repeat-dose), mouse and rat (single-dose), rat (DART), rabbit (local tolerance)
Gardasil 9
human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPsRat only (repeat-dose, fertility/embryo-foetal and postnatal studies)
HBVaxPro
hepatitis B vaccine (rDNA) · HBsAg VLPsRat (repeat-dose); mouse and rat (single-dose), using the HBsAg-containing combination vaccine HEXAVAC
Heplisav-B
hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)Mouse, rat and cynomolgus monkey (repeat-dose); rabbit and baboon escalation studies
Mosquirix
RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)Rabbit (vaccine repeat-dose); rat and rabbit for adjuvant components
Nuvaxovid
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)Rabbit for the adjuvanted vaccine; rats and rabbits for Matrix-M1 adjuvant studies
PreHevbrio
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPsRat only
Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)Rat and rabbit