PR89437

GAITHERSBURG, Md., May 11, 2021 /PRNewswire=KYODO JBN/ --

- Manuscript highlights development of robust responses to both influenza and

COVID-19 and protection against the SARS-CoV-2 virus

- Data shared via preprint server for biology, bioRxiv, ahead of publication

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

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

from a preclinical study of the company's combination quadrivalent seasonal flu

vaccine (NanoFlu(TM)) and COVID-19 vaccine candidate (NVX-CoV2373). The

NanoFlu/NVX-CoV2373 combination vaccine demonstrated positive immune responses

to both influenza and SARS-CoV-2. A pre-print of the manuscript is available at

bioRxiv.org (

https://c212.net/c/link/?t=0&l=en&o=3157243-1&h=509286301&u=https%3A%2F%2Fwww.biorxiv.org%2Fcontent%2F10.1101%2F2021.05.05.442782v1&a=bioRxiv.org

).

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The manuscript, titled 'Combination Respiratory Vaccine Containing Recombinant

SARS-CoV-2 Spike and Quadrivalent Seasonal Influenza Hemagglutinin

Nanoparticles with Matrix-M(TM) Adjuvant,' studied a combination vaccine

comprising a quadrivalent nanoparticle influenza vaccine formulated together

with a recombinant SARS-CoV-2 spike protein vaccine and Matrix-M(TM) adjuvant.

The combination vaccine elicited robust responses to both influenza A and B and

protected against the SARS-CoV-2 virus. Clinical studies of the combination

vaccine are expected to begin by the end of the year.

"Despite low rates during the COVID-19 pandemic, influenza remains a

significant risk to global public health and the need for versatile, more

effective vaccines is as important as ever, including against the flu. This

study's results build on our success to-date with NVX-CoV2373, and with

NanoFlu, which successfully achieved all of its objectives in a pivotal Phase 3

trial announced last year," said Gregory M. Glenn, M.D., President of Research

and Development, Novavax. "We believe that this novel combination vaccine

candidate, which leverages Novavax' technology platform and Matrix-M(TM)

adjuvant, could be an important future tool in the long-term fight against both

of these harmful respiratory viruses."

Immunogenicity Results

The preclinical study found that the combination NanoFlu/NVX-CoV2373

(qNIV/CoV2373) vaccine induced functional influenza and COVID antibodies in

ferrets. Hemagglutination inhibition (HAI) and ACE2 receptor-inhibiting titers

were comparable between immunization with the combination vaccine and with its

respective component vaccines. Antibody titers were elevated two weeks after a

single dose and increased even further two weeks following a second

immunization.

Hamsters that received the combination NanoFlu/NVX-CoV2373 vaccine had elevated

levels of SARS-CoV-2 anti-S IgG two weeks after the first immunization, which

increased significantly after a second dose, with levels comparable to animals

that received the NVX-CoV2373 vaccine alone. Human ACE2 receptor inhibiting

antibody levels responded similarly. The immune responses to influenza A and B

strains elicited by NanoFlu/NVX-CoV2373 were comparable to immunization with

NanoFlu alone. Further, the combination vaccine induced antibodies against

SARS-CoV-2 neutralizing epitopes, including at hidden or cryptic sites, that

are common between USA-WA1 and the B.1.351 variant.

Protection after SARS-CoV-2 challenge

When hamsters were challenged with SARS-CoV-2, animals immunized with

NanoFlu/NVX-CoV2373 retained their body weight comparably to non-infected

animals and those immunized with NVX-CoV2373 alone. An examination of viral

load in the upper and lower respiratory tract showed that little or no virus

was detected four days after COVID-19 infection in animals immunized with

NanoFlu/NVX-CoV2373 or with just NVX-CoV2373. Microscopic and macroscopic

observations of the lungs showed no remarkable findings in animals immunized

with either the combination vaccine or with NVX-CoV2373 alone.

"Seasonal influenza and COVID-19 combination vaccines will likely be critical

to combating emerging COVID-19 variants," said Russell 'Rip' Wilson, Executive

Vice President and NanoFlu General Manager, Novavax. "Millions of people are

affected by influenza each year in the U.S., and despite our vaccination

efforts, currently available flu vaccines are only partially effective. Our

NanoFlu vaccine Phase 3 clinical trial achieved all of its primary endpoints,

and we expect this combination vaccine will help control both COVID-19 and

influenza illness."

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 adjuvanted with Novavax' patented saponin-based Matrix-M(TM) 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 100% protection against severe disease, efficacy of

96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1

variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that

began in December 2020. 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

100% protection against severe disease 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.

About Matrix-M(TM)

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 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=3157243-1&h=82310253&u=https%3A%2F%2Ftwitter.com%2Fnovavax&a=Twitter

) and LinkedIn (

https://c212.net/c/link/?t=0&l=en&o=3157243-1&h=3060087260&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fnovavax&a=LinkedIn

).

Novavax 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 (

https://c212.net/c/link/?t=0&l=en&o=3157243-1&h=3739578274&u=http%3A%2F%2Fsec.gov%2F&a=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

Novavax Media

Amy Speak | +1 617-420-2461

Laura Keenan | +1 202-709-7521

media@novavax.com

SOURCE  Novavax, Inc.