8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): February 10, 2022 

NOVAVAX, INC.

(Exact name of registrant as specified in charter)  

Delaware	0-26770	22-2816046
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

21 Firstfield Road

Gaithersburg, Maryland 20878

(Address of Principal Executive Offices, including Zip Code)

(240) 268-2000

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, Par Value $0.01 per share	NVAX	The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01. Regulation FD Disclosure.

On February 10, 2022, Novavax, Inc. (the “Company”) announced that it will host a conference call to discuss the results of the pediatric expansion of its PREVENT-19 Phase 3 trial of NVX-Cov2373, the Company’ recombinant nanoparticle protein-based COVID-19 vaccine candidate. A slide presentation to be used by senior management of the Company in connection with its discussions with investors (the “Investor Presentation”) is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference. A copy of the Investor Presentation will also be accessible on the Company’s website at www.novavax.com under “For Investors/Events.” A copy of the press release announcing the conference call (the “Press Release”) is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference.

The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section and shall not be deemed incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such filing. In addition, the contents of the Company’s website are not incorporated by reference into this Current Report on Form 8-K and you should not consider information provided on the Company’s website to be part of this Current Report on Form 8-K.

Cautionary Note Regarding Forward-Looking Statements. The Investor Presentation and Press Release contain forward-looking statements that involve certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these statements. Please refer to the cautionary notes in the Investor Presentation and Press Release regarding these forward-looking statements.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Investor Presentation of Novavax, Inc.
99.2	Press Release, dated February 10, 2022, regarding the announcement of the Company’s conference call to discuss the results of the pediatric expansion of its PREVENT-19 Phase 3 trial of NVX-CoV2373.
104	Cover Page Interactive Data File (formatted as Inline XBRL).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Novavax, Inc.
Date: February 10, 2022	By:	/s/ John A. Herrmann III
	Name:	John A. Herrmann III
	Title:	Executive Vice President, Chief Legal Officer and Corporate Secretary

EX-99.1

Exhibit 99.1

PREVENT - 19 PHASE 3 ADOLESCENT RESULTS 1 © 2022 NOVAVAX. All rights reserved. February 10, 2022

SAFE HARBOR STATEMENT Certain information, particularly information relating to the future of Novavax, its operating plans and prospects, its partn ers hips, the ongoing development of NVX - CoV2373, including Novavax’ plans for a subsequent pediatric study planned for Q2 2022, COVID - NanoFlu combination vaccine an d other Novavax vaccine product candidates, the timing of results from clinical trials, the potential for a booster dose of NVX - CoV2373 to provi de protection against COVID - 19 (including variants), the scope and timing of future regulatory filings and actions, including Novavax’ plans to supplement g lob al regulatory filings with pediatric data in Q1 2022, anticipated manufacturing capacity, the readiness of our global supply chain and future availabili ty of NVX - CoV2373 at a global scale and the anticipated commercialization of NVX - CoV2373 constitute forward - looking statements within the meaning of the Priva te 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 oth er words with similar meanings. 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 p rod uct characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities ; d ifficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax t o p ursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other enti tie s; and those other risk factors identified in the “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Oper ati ons” sections of Novavax' Annual Report 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 www.sec.gov and www.novavax.com. Forward - looking statements are based on current expectations and assumptions and currently available data and are neither predic tions nor guarantees of future events or performance. Current results may not be predictive of future results. You should not place considerable 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 ne w information, future events, or otherwise, except as required by applicable law. Novavax Œ (and all associated logos) is a trademark of Novavax, Inc. Matrix - M Œ is a trademark of Novavax AB. 2 © 2022 NOVAVAX . All rights reserved.

Randomized, observer - blinded, placebo - controlled trial evaluating efficacy, immunogenicity and safety PREVENT - 19 PHASE 3 TRIAL DESIGN • Primary endpoint : PCR - positive symptomatic mild, moderate or severe COVID - 19 illness diagnosed ≥ 7 days after second dose • 2:1 randomization 3 © 2022 NOVAVAX. All rights reserved. 5µg + 50µg Matrix - M adjuvant 2 injections, 21 days apart n = ~20,000 Placebo 2 injections, 21 days apart n = ~10,000 29,960 Adults > 18 years R 2:1 Placebo 2 injections, 21 days apart 5µg + 50µg Matrix - M adjuvant 2 injections, 21 days apart ClinicalTrials.gov Identifier: NCT04611802 . Protocol v10.0 posted on Novavax.com

Licensure - enabling Effectiveness Endpoint confirmed with regulators PREVENT - 19 PHASE 3: PEDIATRIC EXPANSION TO ADOLESCENTS 4 © 2022 NOVAVAX. All rights reserved. • Primary Effectiveness Endpoint : Non - inferiority of neutralizing antibody responses versus young adults (18 to <26 years) • Primary endpoint : PCR - positive symptomatic mild, moderate or severe COVID - 19 illness diagnosed ≥ 7 days after second dose • 2:1 randomization 5µg + 50µg Matrix - M adjuvant 2 injections, 21 days apart n = ~1,500 Placebo 2 injections, 21 days apart n = ~750 2,247 Adolescents 12 to <18 years R 2:1 Placebo 2 injections, 21 days apart 5µg + 50µg Matrix - M adjuvant 2 injections, 21 days apart ClinicalTrials.gov Identifier: NCT04611802 . Protocol v10.0 posted on Novavax.com

Dose 1 : April 26 – June 5, 2021 Dose 2 : May 17 – July 12, 2021 Per Protocol Efficacy Endpoint Accrual : May 24 – September 27 19B DELTA STRAIN DOMINATED PREVALENCE DURING EFFICACY COLLECTION WINDOW 5 © 2022 NOVAVAX. All rights reserved. Figure source: Nextstrain.org

DEMOGRAPHICS WELL BALANCED BETWEEN PLACEBO AND VACCINE, WITH ADEQUATE RACE AND ETHNIC REPRESENTATION 6 © 2022 NOVAVAX. All rights reserved. NVX - CoV2373 n=1,487 Placebo n=745 Female 49.2% 44.2% 12 to <15 years of age 67.1% 67.1% 15 to <18 years of age 32.9% 32.9% White 75.0% 73.2% Black or African American 13.6% 14.5% Hispanic or Latino 18.4% 18.5% Baseline anti - N positive 15.3% 16.2%

16.3% 6.4% 0.4% 0.1% 0.5% 0.0% 15.8% 6.8% 0.3% 0.1% 0.3% 0.0% 0% 20% 40% 60% 80% 100% Any AE Any Medically Attended AE Any Severe AE AE leading to vaccine discontinuation Serious AE Deaths NVX-CoV2373 Placebo Overview up to crossover SAFETY EVENTS WERE BALANCED BETWEEN VACCINE & PLACEBO 7 © 2022 NOVAVAX. All rights reserved. • No PIMMC or AESI were reported • SAEs were infrequent and balanced between groups (n=1,487) (n=745)

0% 20% 40% 60% 80% 100% 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 Pain Tenderness Redness Swelling 0% 20% 40% 60% 80% 100% 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 Pain Tenderness Redness Swelling Any Grade 3+ Pain Tenderness Redness Swelling Reactogenicity in 12 to <15 y/o vs 15 to <18 y/o LOCAL: NO DIFFERENCE IN YOUNGER VS OLDER ADOLESCENTS 8 © 2022 NOVAVAX. All rights reserved. First Dose: • Any Grade (Grade >1 ) generally similar to adults • Grade 3+ similar to adults Second Dose: • Any Grade (Grade >1 ) generally similar to adults, higher for redness and swelling • Grade 3+ similar to adults

Reactogenicity in 12 to <15 y/o vs 15 to <18 y/o SYSTEMIC: NO DIFFERENCE IN YOUNGER VS OLDER ADOLESCENTS 9 © 2022 NOVAVAX. All rights reserved. 0% 20% 40% 60% 80% 100% 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 Any Grade 3+ Muscle pain Headache Fatigue Malaise Nausea/ Vomiting Joint Pain Fever First Dose: • Any Grade (Grade >1 ) generally similar to adults, higher for muscle pain • Grade 3+ similar to adults 0% 20% 40% 60% 80% 100% 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 12 to <15 15 to <18 Second Dose: • Any Grade (Grade >1 ) generally lower or similar than in adults, higher for headache, fever, nausea/vomiting • Grade 3+ generally similar or slightly higher than adults

LICENSURE - ENABLING EFFECTIVENESS ENDPOINT ACHIEVED: ADOLESCENTS NON - INFERIOR TO ADULTS (18 TO <26 Y/O) Day 35 WT neutralization * response 10 © 2022 NOVAVAX. All rights reserved. Main Study 18 to <26 years Adolescents 12 to <18 years GMT 2,634 (95% CI: 2,389, 2,904) 3,860 (95% CI: 3,423, 4,352) GMR 1.5 (1.3, 1.7) Seroconversion 99.8% (95% CI: 98.7, 100) 98.7% (95% CI: 97.0, 99.6) Difference 1.1 ( - 0.2, 2.8 ) • U.S./Mex Phase 3: WT neutralization GMT = 1,078 (95% CI: 968, 1,201) • U.K. Phase 3: WT neutralization GMT = 1,133 (95% CI: 999, 1,285) * Validated Wild - Type neutralization assay performed at 360Bio Labs

DAY 35 I g G * MAGNITUDE HIGHER THAN 18 TO <25 Y/O ADULTS IN MAIN STUDY 11 © 2022 NOVAVAX. All rights reserved. 12 to <18 137,671 EU/mL 12 to <15 145,817 EU/mL 15 to <18 121,732 EU/mL 18 to <26 99,386 EU/mL IgG by Age Group GMR = 1.4 (95% CI: 1.2, 1.6) in adolescents vs 18 to <26 y/o * Validated prototype IgG ELISA assay performed at Novavax Clinical Immunology

Adolescent IgG following 2 - dose primary series (Day 35) VARIANT I g G RESPONSES 2 - 3X HIGHER THAN IN ADULTS; 100% SEROCONVERSION AGAINST ALL VARIANTS 12 © 2022 NOVAVAX. All rights reserved. Anti - rS IgG Titer (EC50) 1 10 100 1,000 10,000 100,000 1,000,000 Prototype Alpha Beta Delta Delta+ Gamma Mu Omicron LOD = 10 B.1.1.7 B.1.351 B.1.617.2 AY.4.2 P.1 B.1.621 B.1.1.529 Fit - for - purpose assay performed at Novavax Discovery labs

Adolescent hACE2 receptor inhibition following 2 - dose primary series (Day 35) ADOLESCENT FUNCTIONAL IMMUNE RESPONSES AGAINST VARIANTS 2.4 - 4X HIGHER THAN IN ADULTS 13 © 2022 NOVAVAX. All rights reserved. LOD = 10 50% Receptor Inhibition Titer (log 10 ) 1 10 100 1,000 Prototype Alpha Beta Delta Delta+ Gamma Mu Omicron B.1.1.7 B.1.351 B.1.617.2 AY.4.2 P.1 B.1.621 B.1.1.529 Fit - for - purpose assay performed at Novavax Discovery labs

VACCINE EFFICACY: 79.5% 14 © 2022 NOVAVAX. All rights reserved. • Sequence available for 11/20 cases: 100% of sequenced cases determined to be Delta variant • Lower bound of 95% CI >30% • 95% CI includes estimate from large adult population VE = 90.4% (95% CI: 82.8, 94.6) Efficacy Endpoint: PCR+ mild, moderate or severe COVID - 19 occurring ≥7 days after 2nd dose in baseline seronegative participants NVX - CoV2373 n=1,199 Placebo n=580 Total 6 14 Mild 6 14 Moderate 0 0 Severe 0 0 Vaccine Efficacy 79.5% (95% CI: 46.8, 92.1)

EFFICACY CONSISTENT BETWEEN ADOLESCENT AGE GROUPS 15 © 2022 NOVAVAX. All rights reserved. • Small number of cases yields wide 95% CI • 95% CI include estimate from large adult dataset • Efficacy endpoint : PCR+ mild, moderate or severe COVID - 19 occurring ≥7 days after 2nd dose in baseline seronegative participants 12 to <15 y/o 15 to <18 y/o NVX - CoV2373 n=822 Placebo n=407 NVX - CoV2373 n=383 Placebo n=187 Total 4 10 2 4 Vaccine Efficacy 80.7% (95% CI: 38.5, 93.9) 76.8% (95% CI: - 26.7, 95.7)

82.0% EFFICACY AGAINST DELTA COVID - 19 ILLNESS 16 © 2022 NOVAVAX. All rights reserved. • Lower bound of 95% CI >30% • All VOC/VOI were Delta • Efficacy endpoint : PCR+ mild, moderate or severe COVID - 19 occurring ≥7 days after 2nd dose in baseline seronegative participants Sequence is available for 11 cases (55%): All were the Delta Variant of Concern (VOC) NVX - CoV2373 n=1,205 Placebo n=594 Total 3 8 Mild 3 8 Moderate 0 0 Severe 0 0 Vaccine Efficacy 82.0% (95% CI: 32.4, 95.2)

SUMMARY 17 © 2022 NOVAVAX. All rights reserved. • No safety signal observed in preliminary dataset up to crossover • Vaccine was well tolerated • Reactogenicity was generally similar or lower magnitude and severity compared to adult part of the study • Overall IgG and wild - type neutralization responses higher than observed in adults • IgG and hACE2 - inhibition against variants also higher than observed in adults • Achieved Primary Effectiveness endpoint with neutralizing antibody responses non - inferior to young adults • Adolescent neutralization responses ~1.5 - fold higher than adults • Efficacy against symptomatic Delta variant infection 82.0% (95% CI: 32.4, 95.2 ) • Overall efficacy 79.5% (95% CI: 46.8, 92.1) • Achieved statistical success criteria with lower bound of 95% CI >30% • All illness in this dataset was mild, often more difficult to prevent with vaccination • Small number of cases resulted in broad confidence internal which overlap with adult part of study ( VE = 90.4% (95% CI: 82.8,94.6) • Findings consistent between 12 to <15 y/o and 15 to <18 y/o

NEXT STEPS IN PEDIATRIC PROGRAM 18 © 2022 NOVAVAX. All rights reserved. • Supplement Global Filings with Pediatric Data: Q1 2022 • Pediatric investigations plan: Agreed to by FDA, MHRA, EMA • Subsequent pediatric study planned for Q2 2022

EX-99.2

Exhibit 99.2

 

Novavax Announces Positive Results of COVID-19 Vaccine in Pediatric Population of PREVENT-19 Phase 3 Clinical Trial

· PREVENT-19 pediatric expansion in adolescents aged 12 through 17 achieved primary effectiveness endpoint demonstrating comparability to adult population

· Trial demonstrated 82% clinical efficacy against Delta variant

· Immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied

· Vaccine was well-tolerated with no safety signals identified

· Novavax plans to supplement global regulatory filings with pediatric data in Q1 2022

· Company to host investor conference call today from 4:30 - 5:00 pm ET

GAITHERSBURG, Md. – Feb. 10, 2022 – Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, achieved its primary effectiveness endpoint in the pediatric expansion of its PREVENT-19 pivotal Phase 3 trial and demonstrated 80% efficacy overall at a time when the Delta variant was the predominant circulating strain in the U.S. The study enrolled 2,247 adolescents aged 12 through 17-years across 73 sites in the U.S. to evaluate safety, effectiveness (immunogenicity), and efficacy, with an emphasis on ensuring well balanced racial and ethnic representation among participants.

“We are encouraged by the results in this adolescent population given the ongoing need for alternative vaccine options for COVID-19,” said Filip Dubovsky, MD, Chief Medical Officer, Novavax. “We believe the Novavax vaccine offers a differentiated technology and option for this younger population given its established protein-based technology already used in other vaccines, and the positive responses demonstrated against variants.”

The primary PREVENT-19 pivotal Phase 3 trial conducted in adults aged 18 years and older, results of which were published in The New England Journal of Medicine (NEJM), enrolled approximately 30,000 participants in the U.S. and Mexico. NVX-CoV2373 achieved 90.4% efficacy overall and demonstrated a reassuring safety and tolerability profile. Serious and severe adverse events in adults were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed in adults during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, for both the primary PREVENT-19 trial and the pediatric expansion, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

1 

NVX-CoV2373 has not yet been authorized in the adolescent population. Novavax expects to submit its regulatory filings for a pediatric indication in adolescents aged 12 through 17-years to global regulatory authorities during the first quarter of 2022. Novavax also expects to initiate additional studies globally evaluating younger age groups during the second quarter of 2022.

To date, NVX-CoV2373 has received authorization from multiple regulatory authorities globally, including conditional marketing authorization from the European Commission, the Medicines and Healthcare products Regulatory Agency, and emergency use listing (EUL) from the World Health Organization (WHO). With WHO EUL, there is the opportunity for authorization in over 170 countries with a potential reach of over six billion lives. The vaccine is also currently under review by multiple regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA).

Results: Clinical efficacy consistent between adolescent and adult participants

In the placebo-controlled, observer-blinded study, adolescent participants were randomized 2:1 to receive active vaccine or placebo. Study participants underwent blinded crossover to alternate study material after the required safety data were collected to ensure that all participants received active vaccine. During the period of placebo-controlled observation, NVX-CoV2373 demonstrated overall protective efficacy of 79.5% (95% CI: 46.8, 92.1) against COVID-19. Efficacy was consistent across age groups and all cases observed in the vaccine group were mild as defined by the trial protocol.

Efficacy endpoints were accrued from May 24 through September 27, 2021 – a time when the Delta variant was the predominant strain in the U.S., showing high transmission and high severity of disease. Sequence data are available for 11 of the 20 confirmed cases, 100% of which were determined to be caused by the Delta variant. Vaccine efficacy against the Delta variant was 82.0% (95% CI: 32.4, 95.2).

Results: Consistent response to variants

Data from the pediatric expansion of PREVENT-19 showed in post hoc analyses robust immune responses in adolescents, including IgG responses against Spike proteins of several variants (including Alpha, Beta, Delta, Gamma, Mu, and Omicron) that were 2-3-fold higher than in adults, with 100% seroconversion against all variants following a 2-dose series of vaccinations. Adolescent functional immune responses (hACE2 receptor inhibition) against these variants were 2.4-4-fold higher than in adults against all evaluated variants.

Results: A reassuring safety and reactogenicity profile

Preliminary safety data from the pediatric expansion of PREVENT-19 showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No safety signal was observed through the placebo-controlled portion of the study.

2 

Study Endpoints

The pediatric expansion of PREVENT-19 achieved its primary effectiveness (immunogenicity) endpoint, with neutralizing antibody responses non-inferior to those observed in young-adult (18 to 26 years old) participants from PREVENT-19. Adolescent neutralizing antibody responses using wild-type SARS-CoV-2 were approximately 1.5-fold higher in adolescents than in young adults, meeting FDA-specified criteria.

About PREVENT-19

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M™ adjuvant in 29,960 participants 18 years of age and older in 119 locations in the United States and Mexico, compared with placebo. The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the safety, effectiveness, and efficacy of NVX-CoV2373 with Matrix-M™ adjuvant in 2,247 adolescent participants 12- to 17-years of age in 73 locations in the United States, compared with placebo.

PREVENT-19 is being conducted with support from the U.S. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is providing up to $1.75 billion under a Department of Defense agreement.

Conference Call

Novavax will host a conference call for investors today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 870-4263 (Domestic) or (412) 317-0790 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 7:30 p.m. ET on February 10, 2022 until 11:59 p.m. ET on February 17, 2022. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 3932770. 

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until May 10, 2022.

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About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

About the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.

PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants aged 18 years and older, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).

A trial conducted in the U.K. with 14,039 participants aged 18 years and older was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.

4 

About Matrix-M™ Adjuvant

Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and generally well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza investigational vaccine candidate. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, including Novavax’ plans to initiate additional global studies in Q1 2022, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement global regulatory filings with the pediatric data in Q1 2022 and the opportunity for authorization in over 170 countries, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, and the efficacy, safety and intended utilization of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such 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; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’ Annual Report 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 (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

Investors

Novavax, Inc.

Erika Schultz | 240-268-2022

ir@novavax.com

Solebury Trout

Alexandra Roy | 617-221-9197

aroy@soleburytrout.com

Media

Ali Chartan | 240-720-7804

Laura Keenan Lindsey | 202-709-7521

media@novavax.com

5 

XML

Cover	Feb. 10, 2022
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 10, 2022
Entity File Number	0-26770
Entity Registrant Name	NOVAVAX, INC.
Entity Central Index Key	0001000694
Entity Tax Identification Number	22-2816046
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	21 Firstfield Road
Entity Address, City or Town	Gaithersburg
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20878
City Area Code	240
Local Phone Number	268-2000
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, Par Value $0.01 per share
Trading Symbol	NVAX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false