Arexvy
respiratory syncytial virus vaccine, adjuvanted (AS01E) · RSV preF3; TLR4 (AS01E adjuvant)In mice, AS01-adjuvanted RSVPreF3 induced CD4+/CD8+ T cells, neutralising antibodies and proinflammatory cytokines
Mosquirix: which risks did reviewers probe?
RTS,S/AS01 malaria vaccine · P. falciparum CSP-HBsAg (RTS,S) VLPs; TLR4 (AS01 adjuvant)
Immune & cytokine safety
Transient neutrophil and fibrinogen increases after dosing, back to pre-dose levels within three days
“The neutrophil counts and fibrinogen concentrations showed evidence of a return to levels similar to those recorded before treatment commenced within three days after dosing.”
Biodistribution & persistence
Adjuvant only: QS-21 eliminated almost exclusively in urine (>99% by 72 h) in mice; antigen PK not studied
“[14C]-QS-21 was almost exclusively eliminated via urinary excretion with >99 % of the injected dose recovered in urine by 72 h after dosing.”
Modality-specific risk
Adjuvant (AS01B) haematology effects: transient haemoglobin decrease in rats; bone marrow red cell production unaffected
“These changes in haemoglobin occurred despite no change to red cell number. Based on this result, AS01B was concluded not to affect the ability of bone marrow to produce red blood cells.”
Anti-drug antibodies: animals
All vaccinated rabbits seroconverted, none of the controls; confirms immune response
“Serological analysis demonstrated seroconversion in all vaccine treated animals and none in the saline-treated controls, confirming that the rabbit is an immunological responder species for the RTS,S/AS01B candidate vaccine formulation.”
Anti-drug antibodies: patients
Intended response: 98.9% of 5-17-month-olds seroprotected for anti-HBs before and after booster
“In the 5-17 months age category, 98.9% of RTS,S/AS01E recipients (R3R group) had seroprotective levels ( ≥10 mIU/ml) of anti-HBs antibodies both pre-booster (Month 20) and one month post booster dose of RTS,S/AS01E (Month 21).”
Same question, other vaccines
Cervarix
human papillomavirus bivalent (types 16, 18) vaccine, recombinant, AS04-adjuvanted · HPV 16/18 L1 VLPs; TLR4 (AS04 adjuvant)No neurological, immunological or autoimmune adverse reactions in MPL-containing preclinical studies (FDA concurred)
Cyfendus
anthrax vaccine adsorbed, adjuvanted · B. anthracis PA; TLR9 (CpG 7909 adjuvant)Transient neutrophil, monocyte, basophil and inflammatory-marker increases; spleen weight increase and lymphoid hyperplasia
Fendrix
hepatitis B vaccine (rDNA), AS04C-adjuvanted · HBsAg VLPs; TLR4 (AS04C adjuvant)Anti-HBs seroconversion in rabbits; rat dams and offspring exposed to high anti-HBs titres
Gardasil
human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant · HPV 6/11/16/18 L1 VLPsTheoretical autoimmunity from cross-reactive antibodies, not readily studied in animals; left to clinical assessment
Gardasil 9
human papillomavirus 9-valent vaccine, recombinant · HPV 9-valent L1 VLPsTransient spleen weight increase from immune stimulation; theoretical autoimmunity risk left to post-marketing
HBVaxPro
hepatitis B vaccine (rDNA) · HBsAg VLPsNo autoimmune reactions, kidney or vascular lesions, or immune complex deposition in the rat repeat-dose study
Heplisav-B
hepatitis B vaccine (recombinant), adjuvanted · HBsAg; TLR9 (CpG 1018 adjuvant)Serum IL-12p40 rose only 2-fold at ~20x the human CpG 1018 dose; no IL-12p40 or IFN-gamma increase at the 1x human dose
Nuvaxovid
COVID-19 vaccine, recombinant spike protein nanoparticle, Matrix-M-adjuvanted · SARS-CoV-2 spike (nanoparticle)Matrix-M1: injection-site inflammation, reversible draining lymph node enlargement, raised CRP, fibrinogen and globulin (immune stimulation)
PreHevbrio
hepatitis B vaccine (recombinant), 3-antigen · HBsAg S/pre-S1/pre-S2 VLPsSlight lymphoid hyperplasia in spleen and lymph nodes, an expected immunostimulatory effect
Shingrix
zoster vaccine recombinant, AS01B-adjuvanted · VZV glycoprotein E; TLR4 (AS01B adjuvant)Acute-phase response (CRP rise) indicating systemic inflammation, possibly linked to malaise, fatigue and nausea
Flublok
influenza vaccine, recombinant hemagglutinin · Influenza HANot stated in public reviews