PR91541

GAITHERSBURG, Md., Sept. 8, 2021 /PRNewswire=KYODO JBN/ --

-- First participants enrolled in Phase 1 clinical trial of combination

NanoFlu(TM)/NVX–CoV2373 vaccine with Matrix-M(TM) adjuvant

-- Phase 1/2 study will evaluate immunogenicity and safety

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing

and commercializing next-generation vaccines for serious infectious diseases,

today announced enrollment of the first participants in a Phase 1/2 study to

evaluate the safety and immunogenicity of a combination vaccine using Novavax'

seasonal influenza and COVID-19 vaccines. The clinical trial combines Novavax'

recombinant protein-based NVX-CoV2373 and NanoFlu(TM) vaccine candidates and

patented saponin-based Matrix-M(TM) adjuvant in a single formulation

(COVID-NanoFlu Combination Vaccine). Both NVX-CoV2373 and NanoFlu have

previously demonstrated strong results as standalone vaccines in Phase 3

clinical trials.

"This study is the first-of-its-kind to evaluate the vaccine's potential to

induce a robust immune response, augmented by our Matrix-M adjuvant, against

two life-threatening diseases simultaneously," said Gregory M. Glenn, M.D.,

President of Research and Development, Novavax. "The combination of these two

vaccines, which have individually delivered outstanding results with favorable

safety and tolerability profiles, may lead to greater efficiencies for the

healthcare system and achieve high levels of protection against COVID-19 and

influenza with a single regimen."

The trial will evaluate the safety, tolerability and immune response to NanoFlu

formulated together with NVX-CoV2373 and Matrix-M adjuvant in 640 healthy

adults 50 to 70 years of age. Participants will have been either previously

infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated through

an authorized vaccine at least eight weeks prior to enrollment. All

participants will be randomly assigned to cohorts to evaluate multiple

formulations and will be dosed on Day 0 and again at Day 56. The trial will be

conducted in Australia at up to 12 study sites, with results expected during

the first half of 2022.

In preclinical studies (https://c212.net/c/link/?t=0&l=en&o=3283188-1&h=1854070235&u=https%3A%2F%2Fir.novavax.com%2F2021-05-10-Novavax-Announces-Positive-Preclinical-Data-for-Combination-Influenza-and-COVID-19-Vaccine-Candidate&a=preclinical+studies), the COVID-NanoFlu Combination Vaccine demonstrated robust, functional immune

responses to each component of the quadrivalent influenza vaccine and the

SARS-CoV-2 spike protein, with Matrix-M adjuvant playing a key role.

In a Phase 3 clinical trial with nearly 30,000 adults in the United States and

Mexico, NVX-CoV2373 demonstrated (https://c212.net/c/link/?t=0&l=en&o=3283188-1&h=327581556&u=https%3A%2F%2Fir.novavax.com%2F2021-06-14-Novavax-COVID-19-Vaccine-Demonstrates-90-Overall-Efficacy-and-100-Protection-Against-Moderate-and-Severe-Disease-in-PREVENT-19-Phase-3-Trial&a=demonstrated) 100% protection against moderate and severe COVID-19 infection and 90.4% efficacy overall. In a pivotal Phase 3 trial conducted among adults aged 65 and

older, NanoFlu achieved the primary endpoints, demonstrating non-inferior

immunogenicity to a licensed comparator on all four influenza virus strains

included in the vaccine, while also showing both enhanced wild-type

hemagglutination-inhibiting antibody responses against homologous and multiple

heterologous A/H3N2 strains, and potent induction of T cell responses.

NVX-CoV2373 has also been evaluated (https://c212.net/c/link/?t=0&l=en&o=3283188-1&h=1072184429&u=https%3A%2F%2Fir.novavax.com%2F2021-06-14-Novavax-Announces-Positive-Results-from-First-Study-of-Influenza-Vaccine-and-COVID-19-Vaccine-Candidate-Administered-Simultaneously&a=evaluated) in a co-administration study where it was administered simultaneously with an approved influenza vaccine. The study demonstrated that vaccine efficacy

appeared to be preserved in those receiving both vaccines compared to those

vaccinated with NVX-CoV2373 alone.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate 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(TM) 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. In preclinical studies, NVX-CoV2373

induced antibodies that blocked the binding of spike protein to cellular

receptors and provided protection from infection and disease. It was generally

well-tolerated and elicited robust antibody response in Phase 1/2 clinical

testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the

U.K. that demonstrated efficacy of 96.4% against the original virus strain,

86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the

PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection

against moderate and severe disease and 90.4% efficacy overall. It is also

being tested in two ongoing Phase 2 studies that began in August 2020: A Phase

2b trial in South Africa that demonstrated 55% efficacy overall in HIV-negative

participants and 48.6% efficacy against a newly emerging escape variant first

described in South Africa, and a Phase 1/2 continuation in the U.S. and

Australia.

NVX-CoV2373 is stored and stable at 2 degrees – 8 degrees C, allowing the use

of existing vaccine supply chain channels for its distribution. It is packaged

in a ready-to-use liquid formulation in 10-dose vials. Recombinant spike

protein used in this study was manufactured at Novavax' plant located in the

Czech Republic.

About Matrix-M(TM) Adjuvant

Novavax' patented saponin-based Matrix-M(TM) adjuvant has demonstrated a potent

and 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 NanoFlu(TM)

NanoFlu(TM) is a quadrivalent recombinant hemagglutinin (HA) protein

nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell

baculovirus system. NanoFlu uses HA amino acid protein sequences that are the

same as the recommended wild-type circulating virus HA sequences. NanoFlu

contains Novavax' patented saponin-based Matrix-M(TM) adjuvant.

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 combines the power and speed of

genetic engineering to efficiently produce highly immunogenic nanoparticles

designed to address urgent global health needs. Novavax is conducting

late-stage clinical trials for NVX-CoV2373, its vaccine candidate against

SARS-CoV-2, the virus that causes COVID-19. NanoFlu(TM), its quadrivalent

influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase

3 clinical trial in older adults and will be advanced for regulatory

submission. Both vaccine candidates incorporate Novavax' proprietary

saponin-based Matrix-M(TM) 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 (https://c212.net/c/link/?t=0&l=en&o=3283188-1&h=1345976720&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3158017-1%26h%3D500821283%26u%3Dhttps%253A%252F%252Ftwitter.com%252FNovavax%26a%3DTwitter&a=Twitter) and LinkedIn (https://c212.net/c/link/?t=0&l=en&o=3283188-1&h=1202431571&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3158017-1%26h%3D3702938248%26u%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Fnovavax%252F%26a%3DLinkedIn&a=LinkedIn).

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and

prospects, the ongoing development of NVX-CoV2373 and its partnerships, and

other Novavax vaccine product candidates, the efficacy, safety and intended

utilization of our product candidates, the timing of results from clinical

trials, and the potential for a combination NanoFlu and NVX-CoV2373 vaccine to

lead to greater efficiencies for the healthcare system and achieve high levels

of protection against COVID-19 and influenza 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 | +1 240-268-2022

ir@novavax.com

Solebury Trout

Alexandra Roy | +1 617-221-9197

aroy@soleburytrout.com

Media

Ali Chartan | +1 240-720-7804

Laura Keenan Lindsey | +1 202-709-7521

media@novavax.com

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SOURCE  Novavax, Inc.