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-MTM Adjuvant 

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Recombinant 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 puncture

Presentation Transportation 

& Storage Dosing*

• Single dose for 

previously vaccinated 

with any COVID-19 

vaccine

• If unvaccinated,

2-dose series

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* 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

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N = 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 

24

26

28

210

212

214

216

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

N = 4 7 -5

Bivalent Primary and XBB.1.5 Booster Dose 

Prototype

XBB.1.5XBB.2.3

XBB.1.16

XBB.1.16.6

EG.5.1 

FL.1.5.1

Prototype

XBB.1.5XBB.2.3

XBB.1.16

XBB.1.16.6

EG.5.1 

FL.1.5.1

20

22

24

26

28

210

212

214

216

218

Pseudovirus

Neutralization

(ID50, GMT)

95% CI

LOD

 5 weeks Pre Booster 2 weeks Post XBB.1.5 Boost

 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

N = 5 9

Primary 2 Dose: XBB.1.5 

Prototype

XBB.1.5

XBB.1.16.6

EG.5.1

Prototype

XBB.1.5

XBB.1.16.6

EG.5.1

Prototype

XBB.1.5

XBB.1.16.6

EG.5.1

Prototype

XBB.1.5

XBB.1.16.6

EG.5.1

Prototype

XBB.1.5

XBB.1.16.6

EG.5.1

100

101

102

103

104

105

Th1/Th2

Cytokine+ Cells

(per 106 CD4+

T cells)

Mean

Th1 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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