09 COVID Dubovsky 508

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Data in Support of Novavax XBB.1.5 Vaccine
Dr. Filip Dubovsky , President, Research & Development
September 12, 2023
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Novavax Vaccine Platform: Recombinant Protein 
Particle Plus Matrix -M™ Adjuvant   
2Recombinant protein particle
Native 3-dimensional conformation
Truncated S. frugiperda glycans 
Particulate structure facilitates antigen 
presentation and processing
Novavax 
2023- 2024 vaccine
Matrix -M adjuvant
Induces robust neutralizing antibodies
Induces polyfunctional CD4+ Th1 
Novavax XBB.1.5 Vaccine 2023 -2024 Formulation 
for Individuals ≥12 years
•2 vials per carton
•5 doses per vial
•0.5 mL dose
•Ready to use•Stable at 2°C to 8°C
•9-month shelf life*
•Use within 12 hours of 
first puncturePresentationTransportation & StorageDosing*
•Single dose for previously vaccinated with any COVID -19 
vaccine
•If unvaccinated,2-dose series
3* FDA review ongoing
XBB.1.5 Primary Series 
Neutralizing Responses
Non-human primate data demonstrates Novavax 
vaccine technology induces broadly neutralizing 
antibodies with primary vaccination
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Neutralizing Responses in Macaques: Primary Vaccination with XBB.1.5
Primary vaccination induces comparable neutralizing responses to newly emerging variants
5N = 10; Assay validated for  human samples for Prototype and XBB.1.5
2 Doses: XBB.1.5 rS
Prototype XBB.1.5 XBB.2.3 XBB.1.16 XBB.1.16.6 EG.5.1 FL.1.5.1 242628210212214216
Pseudovirus
Neutralization
(ID50, GMT)
95% CI
LOD
 Variants Pseudovirus
XBB.1.5 Booster Dose 
Neutralizing Responses
Neutralizing responses against XBB subvariants 
achieve levels comparable to homologous XBB.1.5 
response
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Neutralizing Responses in Macaques: Primary Vaccination 
Bivalent BA.5 Vaccine and Boost with XBB.1.5
Boosting with XBB.1.5 induces robust neutralizing responses against emerging XBB subvariants
7 N = 4 -5
Bivalent Primary and XBB.1.5 Booster Dose 
PrototypeXBB.1.5 XBB.2.3XBB.1.16XBB.1.16.6EG.5.1 FL.1.5.1PrototypeXBB.1.5 XBB.2.3XBB.1.16XBB.1.16.6EG.5.1 FL.1.5.12022242628210212214216218
Pseudovirus
Neutralization
(ID50, GMT)
95% CI
LOD  2 weeks Post XBB.1.5 Boost  5 weeks Pre Booster
 6.9x      71x    39x      62x    >150x   >150x  >150x
Cellular Immune Responses
Consistent responses against all variants including 
emerging XBB subvariants
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Th1-Biased CD4+ T Cell Response in Rhesus Macaques 
Immunized with Two Doses of XBB.1.5 Vaccine
Consistent responses against all variants including emerging XBB subvariants
9 N = 5 
Primary 2 Dose: XBB.1.5 
PrototypeXBB.1.5
XBB.1.16.6EG.5.1
PrototypeXBB.1.5
XBB.1.16.6EG.5.1
PrototypeXBB.1.5
XBB.1.16.6EG.5.1
PrototypeXBB.1.5
XBB.1.16.6EG.5.1
PrototypeXBB.1.5
XBB.1.16.6EG.5.1100101102103104105
Th1/Th2
Cytokine+ Cells
(per 106CD4+
T cells)
MeanTh1 Th2
IFN-γ IL-2 TNF-α IL-5 IL-13
Stimulation rS
Public Health Value of Novavax XBB.1.5 Vaccine
•Only protein -based COVID -19 vaccine in US
•Non-clinical data supports use of Novavax XBB.1.5 vaccine
-Induces  robust neutralizing responses against XBB subvariants
-Generates a polyfunctional Th1 -biased CD4+ cellular immune response 
against XBB subvariants
•Presentation facilitates ease of use
-Same dose/formulation/vial for all approved indications (0.5mL/dose)
-Ready to use and refrigerator stable (no mixing, dilution or thawing)
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