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Precedia/Protein and VLP vaccines/Mosquirix/Efficacy evidence

Mosquirix: animal efficacy model or human cells?

RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)
Check my plan vs. these
Efficacy evidence
Immunogenicity in mice and monkeys (3 IM doses, days 0, 14, 28)
“The vaccine schedule was 3 intramuscular (i.m.) injections on days 0, 14 and 28, except GSK041 study in monkeys and two mouse studies (LIMS 20110165, LIMS 20130320) designed with immunobridging objectives.”
✓ VerifiedEMA assessment report, p. 34Source ↗
Why that model
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.
Reviewer's view of the efficacy data
Pharmacology programme adequate; no additional studies required
“The pharmacological testing program proposed for RTS,S/AS01E candidate vaccine is considered adequate and no additional studies are required.”
✓ VerifiedEMA assessment report, p. 57Source ↗

Email me this as a cited memo

Efficacy evidence for Mosquirix, each with the regulator's own words, the page and a link. Ready to paste into a briefing document or send to your team.

Same question, other vaccines

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

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 HA
Mouse 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 VLPs
Immunogenicity 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 VLPs
Immunogenicity in rhesus macaques (non-GLP): antibodies to all 9 HPV types; no protection model

HBVaxPro

hepatitis B vaccine (rDNA) · HBsAg VLPs
C3H 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

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 VLPs
Immunogenicity 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

Summary across all 13 vaccines →