Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Rabbit (repeat-dose toxicity, DART) and rat (DART); mice for immunogenicity only
PreHevbrio: which tox species, and why?
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPs
Species
Rat only
“Toxicology: Three toxicity studies and an intramuscular embryo-fetal developmental and pre- and post-natal reproductive toxicity study in rats were submitted.”
Why that species
Rat immunogenicity data showed the species responds to the vaccine
“The suitability of rats as a model was demonstrated by collected immunogenicity data.”
Surrogate molecule
No surrogate; earlier studies used the previous formulation (AlPO4, thiomersal), later ones the current Al(OH)3 formulation
“Earlier studies used the previous vaccine formulation (AlPO4, with thiomersal) and the remaining studies used the current vaccine formulation (Al(OH)3, without thiomersal).”
Species: general tox
Rat
“Two repeat-dose toxicity studies were performed in rats to evaluate systemic adverse effects and local tolerance, one (IBR 9100.008) using the current vaccine formulation and the other (Weizmann Report 1991) using the old vaccine formulation.”
Species: DART
Rat (combined embryo-fetal and pre/postnatal development, female)
“A GLP-compliant embryo-fetal and pre/post-natal reproductive toxicity study was conducted with the current vaccine formulation of PreHevbri in female Sprague-Dawley rats.”
Species: carcinogenicity
Not conducted (in line with applicable guidelines)
“There were no studies on genotoxicity and carcinogenicity, which is in line with applicable guidelines.”
Surrogate used in
No surrogate used
“Earlier studies used the previous vaccine formulation (AlPO4, with thiomersal) and the remaining studies used the current vaccine formulation (Al(OH)3, without thiomersal).”
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
Fendrix
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)Rabbit (repeat-dose toxicity of the vaccine)
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
Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)Rat and rabbit