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Precedia/Protein and VLP vaccines/HBVaxPro/Safety margin

HBVaxPro: what safety margin did regulators accept?

hepatitis B vaccine (rDNA) · HBsAg VLPs
Check my plan vs. these
Safety margin at NOAEL
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.
NOAEL / key findings
No toxicologically significant findings in rat; changes attributed to the vaccine properties of test and reference vaccines
“revealed changes attributed to the vaccine properties of the reference and tested vaccines. None of these findings had a toxicological significance.”
✓ VerifiedEMA assessment report, p. 4Source ↗

Same question, other vaccines

Arexvy

respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)
Rabbit developmental toxicity study: full antigen dose ≈20x the human dose by body weight (3 kg rabbit, 60 kg human)

Cervarix

human papillomavirus bivalent (types 16, 18) vaccine, recombinant, AS04-adjuvanted · HPV 16/18 L1 VLPs; TLR4 (AS04 adjuvant)
No adverse systemic effects at dosages up to more than 50-fold the human dose (body weight basis)

Fendrix

hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)
Safety pharmacology only: no cardiorespiratory effects up to 63-fold the human dose (bodyweight basis); no repeat-dose margin stated

Gardasil

human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPs
Mouse repeat-dose: ~1450-fold the projected human dose on a body weight basis

Gardasil 9

human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPs
Rat reproduction studies: up to 240 and 160 times the human dose (mg/kg) without fertility or fetal effects

Heplisav-B

hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)
Monkey NOAEL 0.5 mg/kg CpG adjuvant, >10-fold the clinical mg/kg dose, for systemic immunostimulation

Mosquirix

RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)
Rabbit study used RTS,S/AS01B with twice the antigen and adjuvant content of Mosquirix; no numeric margin stated

Nuvaxovid

COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)
Rat DART study: dose exceeds the human dose 40-fold on a weight-adjusted basis

PreHevbrio

hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPs
DART: rats given a dose equivalent to the adult human dose; no numeric multiple stated

Shingrix

zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)
Full human dose given to rabbits, with more doses than clinically; no numeric multiple stated

Cyfendus

anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)
Not stated in public reviews

Flublok

influenza vaccine, recombinant hemagglutinin · Influenza HA
Not stated in public reviews

Summary across all 13 vaccines →