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NVX-CoV2373: Variant-specific immune responses following ...

NVX-CoV2373: Variant-specific immune responses following primary and boosted vaccination 1 2021 NOVAVAX. All rights 22, 2021 SAFE HARBOR STATEMENTC ertain information, particularly information relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, COVID-NanoFluTMcombination vaccine and other Novavax vaccine product candidates, the timing of results from clinical trials, the potential fora booster dose of NVX-CoV2373 to provide protection against COVID-19 (including variants)

Dec 22, 2021 · These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and

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Transcription of NVX-CoV2373: Variant-specific immune responses following ...

1 NVX-CoV2373: Variant-specific immune responses following primary and boosted vaccination 1 2021 NOVAVAX. All rights 22, 2021 SAFE HARBOR STATEMENTC ertain information, particularly information relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, COVID-NanoFluTMcombination vaccine and other Novavax vaccine product candidates, the timing of results from clinical trials, the potential fora booster dose of NVX-CoV2373 to provide protection against COVID-19 (including variants)

2 , the scope and timing of future regulatory filings and actions, anticipated manufacturing capacity, the readiness of our global supply chain and future availability of NVX-CoV2373 at a global scale and the anticipated commercialization of NVX-CoV2373 constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Forward-looking statements may generally contain words such as believe, may, could, will, possible, can, estimate, continue, ongoing, consider, intend, indicate, plan, project, expect, should, would, or assume or variations of such words or other words with similar meanings.

3 Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time and may cause actual results to differ materially from the results discussed in the forward-looking statements. These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways.

4 Challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those otherrisk factors identified in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of Novavax' AnnualReport on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission, which are available at and statements are based on current expectations and assumptions and currently available data and are neither predictions nor guarantees of future events or performance.

5 Current results may not be predictive of future should not placeconsiderable reliance on forward-looking statements which speak only as of the date hereof. The Company does not undertake to update or revise any forward-looking statements after they are made, whether as a result of new information, future events, or otherwise, except as required by applicable and NanoFluare trademarks of Novavax, 2021 NOVAVAX. All rights CLINICAL DEVELOPMENT PROGRAMPHASE & MEXICOD unkle et al., NEJM, 2021, DOIPHASE 3 UNITED KINGDOMH eath et al.

6 , NEJM, 2021, DOIT oback et al., The Lancet Res Med, 2021, DOIPHASE 2bSOUTH AFRICAS hinde et al., NEJM, 2021, DOIPHASE 1 & AUSTRALIAK eech et al., NEJM, 2020, DOIF ormica et al., PLoSMedicine, 2021, DOIN=29,960N=15,203N=4,422N=131 Phase 1N=1,288 Phase 2 Licensure-enabling safety in US population Licensure-enabling efficacy in US populations Licensure-enabling safety data Licensure-enabling efficacy data Safety of co-administration with influenza vaccine Evaluated preliminary efficacy Defined safety profile HIV+ subgroup Established dose level in younger and older adults Confirmed need for adjuvant and 2 dose schedule Defined immunologic phenotype Described preliminary safety profile 2021 NOVAVAX.

7 All rights 2021 NOVAVAX. All rights EFFICACY ACROSS PHASE 3 STUDIESO verall Efficacy Matched / Prototype EfficacyEfficacy Against VariantsEfficacy Against Severe Alpha ( )NS(all 5 severe casesin placebo group) 100% (Non-VoI/VoC) Alpha ( ) All VoI/VoC100% High Risk Phase 3N=15,203 PREVENT-19N=29,960 Anti-Spike IgG Measures the binding of antibody to the variant spike protein Conducted in Novavax Discovery LabsHuman ACE2 inhibition assay A functional assay that measures antibody ability to prevent the variant receptor-binding domain on the spike protein from binding to the human ACE2 receptor Conducted in Novavax Discovery LabsWild-type Neutralization assay A functional assay that measures the ability of antibody to prevent variant viruses from invading cells Conducted in the Matthew FriemanLab.

8 University of Maryland School of Medicine Variant-specific ASSAYS5 2021 NOVAVAX. All rights Phase 2 data after 2 dose primary series and 6-month boost Variant anti-Spike IgG Variant human ACE2 receptor-inhibition Variant wild-type Phase 3 data in adolescents 12-18 years of age after 2 dose primary series Variant anti-Spike IgG Variant human ACE2 receptor-inhibitionDATA AVAILABLE FOR REVIEW6 2021 NOVAVAX. All rights & Australia N=1,288 | Adults aged 18-84 years (n=583; 60-84 years)PHASE 2: DAY 189 BOOST COMPLETE, immune responses EVALUATED ON DAY 2177 2021 NOVAVAX.

9 All rights n=2555 g + Matrix-Mn=25825 g + Matrix-Mn=2595 g + Matrix-Mn=25625 g + Matrix-Mn=255 Day 21 Day 025 g + Matrix-MPlacebo5 g + Matrix-M25 g + Matrix-M5 g + Matrix-MPlacebo5 g + Matrix-M25 g + Matrix-MPlaceboPlaceboPlaceboPlaceboPlac eboDay 189 Placebo5ug +Matrix-MPlacebo5ug +Matrix-MAdditional booster administeredon Day 357 BOOSTED ANTI-SPIKE IgG PROTOTYPE responses GREATER THAN OBSERVED IN PHASE 3 STUDIES8 2021 NOVAVAX. All rights ,00010,000100,0001,000,000UK Ph3 Day 35 PREVENT-19 Day 35US/AU Ph2 Day 217 Anti-Spike IgG (EU/mL, Log10)PREVENT-19 EfficacyNon-VoI/VoC: 100%VoI/VoC: 93% : 94%UK Phase 3 EfficacyPrototype: 96% : 86% assay conducted by Novavax Clinical ImmunologyBOOSTED PROTOTYPE NEUTRALIZATION responses GREATER THAN OBSERVED IN PHASE 3 STUDIES9 2021 NOVAVAX.

10 All rights assay conducted by 360biolabs1001,00010,000100,000UK Ph3 Day 35 PREVENT-19 Day 35US/AU Ph2 Day 217 Wild Type Virus Neutralization (Log10) EfficacyNon-VoI/VoC: 100%VoI/VoC: 93% : 94%UK Phase 3 EfficacyPrototype: 96% : 86%PrototypeBetaDel taAlphaOmicron1001,00010,000100,00 01,000,0 00 PrototypeBetaDel taAlphaOmicronFold increase6-month boosted response increased compared to Day 35;100% seroconversion against all variantsVARIANT-SPECIFIC IgG OBSERVED AFTER 2 DOSE PRIMARY VACCINATION10 2021 NOVAVAX. All rights 35 Day 217 GMT and 95% CILOD = 150**Prototype efficacy of 96-100% in and Phase 3 study.


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