PR91879

GAITHERSBURG, Md., Sept. 24, 2021 /PRNewswire=KYODO JBN/ --

    -- Novavax and Serum Institute of India file regulatory submission for

       World Health Organization Emergency Use Listing of Novavax' recombinant

       nanoparticle protein-based COVID-19 vaccine

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

and commercializing next-generation vaccines for serious infectious diseases,

with its partner, Serum Institute of India Pvt. Ltd. (SII), today announced a

regulatory submission to the World Health Organization (WHO) for emergency use

listing (EUL) of Novavax' recombinant nanoparticle protein-based COVID-19

vaccine candidate with Matrix-M(TM) adjuvant. The submission to WHO is based on

the companies' previous regulatory submission to the Drugs Controller General

of India (DCGI).

"Today's submission of our protein-based COVID-19 vaccine to WHO for emergency

use listing is a significant step on the path to accelerating access and more

equitable distribution to countries in great need around the world," said

Stanley C. Erck, President and Chief Executive Officer, Novavax. "It represents

another major milestone in Novavax' transformation into a commercial global

vaccine company and reinforces the value of global collaboration and need for

multiple approaches to help control the pandemic."

The grant of EUL by the WHO is a prerequisite for exports to numerous countries

participating in the COVAX Facility, which was established to allocate and

distribute vaccines equitably to participating countries and economies. In

addition to the submission for WHO EUL, SII and Novavax last month completed

the submission of modules required by regulatory agencies in India, Indonesia

and the Philippines for the initiation of review of the vaccine, including

preclinical, clinical, and chemistry, manufacturing and controls (CMC) data.

About NVX-CoV2373

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 was

generally well-tolerated and elicited a robust antibody response.

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.

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 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly

21 days apart. The vaccine is stored at 2 degrees- 8 degrees Celsius, enabling

the use of existing vaccine supply and cold chain channels.

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

(https://c212.net/c/link/?t=0&l=en&o=3300920-1&h=1196317460&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=3300920-1&h=1356596439&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 other Novavax vaccine

product candidates, timing of future regulatory filings and actions, and the

role that Novavax may play in helping control the COVID-19 pandemic 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

Alison Chartan | 240-720-7804

Laura Keenan Lindsey | 202-709-7521

media@novavax.com

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SOURCE Novavax