PR92818

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

- Submission to New Zealand's Medsafe marks the first protein-based COVID-19

vaccine submitted for authorization to regulatory authorities in New Zealand

- All modules required for regulatory review of Novavax vaccine, including CMC

data, are now complete for Medsafe

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

and commercializing next-generation vaccines for serious infectious diseases,

today announced the company has filed for provisional approval of the vaccine

to the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

"Today's submission marks Novavax' continued progress in bringing the first

protein-based COVID-19 vaccine based on phase 3 data to the global community,"

said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We

remain laser-focused on delivering our vaccine, which is built on a proven,

well-understood vaccine platform, and thank the Government of New Zealand for

their ongoing partnership and confidence in our COVID-19 vaccine program."

Novavax has now completed the submission to Medsafe of all modules required for

the regulatory evaluation of NVX-CoV2373, a recombinant nanoparticle

protein-based COVID-19 vaccine with Matrix-M(TM) adjuvant. The chemistry,

manufacturing and controls (CMC) module submitted to Medsafe, as well as other

regulatory agencies worldwide, leverage Novavax' manufacturing partnership with

the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine

manufacturer by volume. It will later be supplemented with data from additional

manufacturing sites in Novavax' global supply chain.

The submission includes clinical data from PREVENT-19, a pivotal Phase 3 trial

of 30,000 participants in the U.S. and Mexico that demonstrated 100% protection

against moderate and severe disease and 90.4% efficacy overall. Clinical data

from a pivotal Phase 3 trial of 15,000 participants in the U.K. were also

previously submitted to Medsafe, 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. In both trials, NVX-CoV2373 demonstrated a

favorable safety and tolerability profile.

 

Novavax recently announced regulatory filings for its vaccine in the United

Kingdom (https://c212.net/c/link/?t=0&l=en&o=3345896-1&h=393088484&u=https%3A%2F%2Fir.novavax.com%2F2021-10-27-Novavax-Files-for-Authorization-of-its-COVID-19-Vaccine-in-the-United-Kingdom&a=United+Kingdom), Australia (https://c212.net/c/link/?t=0&l=en&o=3345896-1&h=1077431467&u=https%3A%2F%2Fir.novavax.com%2F2021-10-29-Novavax-Files-for-Provisional-Approval-of-its-COVID-19-Vaccine-in-Australia&a=Australia), and Canada, and the completion of all data and modules in the European Union

(https://c212.net/c/link/?t=0&l=en&o=3345896-1&h=3057253372&u=https%3A%2F%2Fir.novavax.com%2F2021-11-01-Novavax-Files-for-COVID-19-Vaccine-Authorization-with-Health-Canada-and-Completes-Submission-for-Rolling-Review-to-European-Medicines-Agency&a=Canada%2C+and+the+completion+of+all+data+and+modules+in+the+European+Union). The company also expects to complete an additional supplemental filing for

its vaccine for Emergency Use Listing with the World Health Organization

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

end of the year.

This submission was facilitated by the company's local partner, Biocelect Pty.

Ltd., as sponsor.

About the NVX-CoV2373 Phase 3 trials

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. 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=3345896-1&h=1311999227&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3260461-1%26h%3D1316526774%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3158017-1%2526h%253D500821283%2526u%253Dhttps%25253A%25252F%25252Ftwitter.com%25252FNovavax%2526a%253DTwitter%26a%3DTwitter&a=Twitter) and LinkedIn (https://c212.net/c/link/?t=0&l=en&o=3345896-1&h=909592108&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3260461-1%26h%3D1508558197%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3158017-1%2526h%253D3702938248%2526u%253Dhttps%25253A%25252F%25252Fwww.linkedin.com%25252Fcompany%25252Fnovavax%25252F%2526a%253DLinkedIn%26a%3DLinkedIn&a=LinkedIn).

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, and the scope, timing and outcome of future

regulatory filings 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

Alison Chartan | +1 240-720-7804

Laura Keenan Lindsey | +1 202-709-7521

media@novavax.com

Logo - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg

SOURCE  Novavax, Inc.