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
Nuvaxovid: animal efficacy model or human cells?
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)
Efficacy evidence
SARS-CoV-2 live-virus challenge in mice, hamsters, cynomolgus and rhesus macaques
“Live virus challenge studies were performed in mice, hamsters, cynomolgus macaques, and rhesus macaques.”
Why that model
Mice made susceptible by intranasal adenovirus vector expressing human ACE2 before challenge
“The 2 lead antigens were tested for protective effect against SARS-CoV-2 challenge, at 10 μg level, with or without 5 ug Matrix-M1 adjuvant, in a prime-boost regime in mice sensitised for SARS-CoV-2 by intranasal instillation of adenovirus vector expressing human ACE2.”
Reviewer's view of the efficacy data
Robust immune response shown effective against disease symptoms and viral replication in hamsters and macaques
“From the studies in hamsters, cynomolgus macaques and rhesus monkeys, it emerged that vaccination with the BV2373 construct in combination with the adjuvant Matrix-M1 leads to a robust immune response that is proven to be effective against the disease symptoms of SARS-CoV-2 infection and in reducing viral replication.”
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
Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HAMouse immunogenicity (HAI and neutralizing antibodies) with monovalent rH3 and trivalent RIV3; no challenge studies
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)
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