PR92630

GAITHERSBURG, Md., Oct. 28, 2021 /PRNewswire=KYODO JBN/ --

- Filing marks first protein-based COVID-19 vaccine submitted to MHRA for

authorization

- All modules required for regulatory review, including CMC data, are now

complete

- Submission based on Phase 3 data from ~45K patients demonstrating high

efficacy and well-tolerated safety, including against variants

- Submissions to additional global regulatory authorities including EU, Canada

and Australia expected soon

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

and commercializing next-generation vaccines for serious infectious diseases,

today announced the completion of its rolling regulatory submission to the U.K.

Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of

its COVID-19 vaccine candidate. The company's application for Conditional

Marketing Authorization (CMA) marks the first submission for authorization of a

protein-based COVID-19 vaccine in the United Kingdom.

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"This submission brings Novavax significantly closer to delivering millions of

doses of the first protein-based COVID-19 vaccine, built on a proven,

well-understood vaccine platform that demonstrated high efficacy against

multiple strains of the coronavirus," said Stanley C. Erck, President and Chief

Executive Officer, Novavax. "We look forward to MHRA's review and will be

prepared to deliver vaccine doses following what we anticipate will be a

positive decision. We thank the clinical trial participants and trial sites in

the United Kingdom, as well as the U.K. Vaccines Taskforce, for their support

and vital contributions to this program."

Novavax has now completed the submission of all modules required by MHRA for

the regulatory review of NVX-CoV2373, the company's recombinant nanoparticle

protein-based COVID-19 vaccine with Matrix-M(TM) adjuvant. This includes

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

Clinical data from a pivotal Phase 3 trial of 15,000 volunteers in the U.K. was

submitted to MHRA earlier this year in which NVX-CoV2373 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, as well as a favorable safety and

tolerability profile. The submission also includes data from PREVENT-19, a

30,000-person trial in the U.S. and Mexico, which demonstrated 100% protection

against moderate and severe disease and 90.4% efficacy overall. NVX-CoV2373 was

generally well-tolerated and elicited a robust antibody response.

Novavax expects to complete additional regulatory filings in key markets,

including Europe, Canada, Australia, New Zealand, the World Health Organization

and other markets around the world shortly following the U.K. submission. In

the U.S., Novavax expects to submit the complete package to the FDA by the end

of the year. The company continues to work closely with governments, regulatory

authorities and non-governmental organizations (NGOs) in its commitment to

ensuring equitable global access to its COVID-19 vaccine.

"The submission to MHRA leverages our manufacturing partnership with the Serum

Institute of India, the world's largest supplier of COVID-19 vaccines," said

Rick Crowley, Executive Vice President, Chief Operations Officer, Novavax. "In

the near future, we expect to supplement this filing with supply from our

global supply chain."

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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.

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(TM) 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. 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, its operating plans and

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

Novavax vaccine product candidates, the scope, timing and outcome of future

regulatory filings and actions and the preparedness of Novavax to deliver

vaccine doses 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

SOURCE  Novavax, Inc.