Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)Immunogenicity of RSVPreF3 with or without AS01 in naive mice (neutralising antibodies, CD4+/CD8+ T cells); no challenge model
Flublok: animal efficacy model or human cells?
influenza vaccine, recombinant hemagglutinin · Influenza HA
Efficacy evidence
Mouse immunogenicity (HAI and neutralizing antibodies) with monovalent rH3 and trivalent RIV3; no challenge studies
“The results from these studies show that RIV3 and rH3 are immunogenic and can induce serum HAI and nAb antibodies against the influenza strains present in the vaccine.”
Why that model
Extensive human pharmacodynamic data with RIV3 and RIV4; no animal immunogenicity or challenge studies with RIV4
“No specific non-clinical pharmacology studies including immunogenicity and challenge-protection studies in animal models have been performed with RIV4. There is large amount of pharmacodynamics data available in humans with both RIV3 and RIV4, both licensed in the US and manufactured using the same manufacturing process as that intended for EU.”
Reviewer's view of the efficacy data
Mouse immunogenicity data accepted as proof-of-concept, supporting omission of animal protection studies
“These data provide important proof-of-concept and support omission of the protection studies in animals.”
Same question, other vaccines
Cervarix
human papillomavirus bivalent (types 16, 18) vaccine, recombinant, AS04-adjuvanted · HPV 16/18 L1 VLPs; TLR4 (AS04 adjuvant)Immunogenicity in mice and rhesus monkeys (AS04 superior to aluminium alone); no protection model
Cyfendus
anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)Guinea pig and cynomolgus macaque lethal aerosolized B. anthracis spore challenge after two IM vaccinations
Fendrix
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)Immunogenicity in mice: HBsAg with AS04C more immunogenic than with alum
Gardasil
human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPsImmunogenicity in rhesus macaques, chimpanzees and African green monkeys; neutralising antibodies; no HPV challenge model
Gardasil 9
human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPsImmunogenicity in rhesus macaques (non-GLP): antibodies to all 9 HPV types; no protection model
HBVaxPro
hepatitis B vaccine (rDNA) · HBsAg VLPsC3H mouse potency (ED50) testing versus the licensed thiomersal-containing vaccine
Heplisav-B
hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)Anti-HBsAg immunogenicity of the adjuvanted vaccine in mice, rats and baboons
Mosquirix
RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)Immunogenicity in mice and monkeys (3 IM doses, days 0, 14, 28)
Nuvaxovid
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)SARS-CoV-2 live-virus challenge in mice, hamsters, cynomolgus and rhesus macaques
PreHevbrio
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPsImmunogenicity in mice and rats; no challenge model
Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)Immunogenicity (cellular and humoral anti-gE) in mice