PR91028

GAITHERSBURG, Md., Aug. 4, 2021 /PRNewswire=KYODO JBN/ --

-- Agreement for 100 million doses with option for additional 100 million doses

through 2023

-- Expected to be the first protein subunit COVID-19 vaccine available in the

European Union

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

next-generation vaccines for serious infectious diseases, today announced that

it has reached an agreement with the European Commission (EC) for the purchase

of up to 200 million doses of NVX-CoV2373, the company's recombinant

nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M(TM)

adjuvant. The agreement covers the purchase of up to 100 million doses of the

vaccine with the option for an additional 100 million doses through 2023.

Novavax is working to complete its rolling submission for NVX-CoV2373 to the

European Medicines Agency (EMA) in the third quarter of 2021, with delivery of

initial doses expected to begin following approval.

"We thank the European Commission for their partnership in this important step

to expand vaccine options for the citizens of Europe and globally as we work to

bring the first COVID-19 protein subunit vaccine to the market," said Stanley

C. Erck, President and Chief Executive Officer, Novavax. "With clinical data

from our trials showing strong efficacy against Variants of Concern and

Variants of Interest, we believe that our vaccine candidate will play a

critical role in the effort to help control the pandemic in the EU and other

regions in the world."

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

Mexico, NVX-CoV2373 demonstrated 100% protection against moderate and severe

disease and 90.4% overall efficacy. In a Phase 3 clinical trial conducted in

the United Kingdom with approximately 15,000 adults, NVX-CoV2373 showed an

overall efficacy of 89.7%, and more than 96% efficacy against the original

strain of the virus.

"As new coronavirus variants are spreading in Europe and around the world, this

new contract with a company that is already testing its vaccine successfully

against these variants is an additional safeguard for the protection of our

population. It further strengthens our broad vaccine portfolio, to the benefit

of Europeans and our partners worldwide," said Ursula von der Leyen, President

of the European Commission.

Novavax' global supply chain spans more than 10 countries, including facilities

across the European Union from which it plans to ultimately supply doses.

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 B.1.1.7 (Alpha) variant and 89.7% 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 - 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.

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 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 (

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).

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing development

of its vaccine and adjuvant products are forward-looking statements. Novavax

cautions that these forward-looking statements are subject to numerous risks

and uncertainties, which could cause actual results to differ materially from

those expressed or implied by such statements. These risks and uncertainties

include those identified under the heading "Risk Factors" in the Novavax Annual

Report on Form 10-K for the year ended December 31, 2020, 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

sec.gov, 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

Alison Chartan | +1 240-720-7804

Laura Keenan | +1 202-709-7521

media@novavax.com

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SOURCE  Novavax, Inc.