PR91060

Novavax Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination

GAITHERSBURG, Md., Aug. 6, 2021 /PRNewswire=KYODO JBN/ --

- Single booster dose at 6 months of NVX-CoV2373 increased wild-type

neutralizing antibodies more than 4-fold versus primary vaccination series

- Six-fold increase in cross-reactive functional antibodies to Delta variant

compared to primary vaccination series

- Analysis of sera from primary vaccination series also showed cross-reactive

functional antibodies to Alpha, Beta and Delta variants, all of which increased

6- to 10-fold with boost

- Study reinforces mostly mild and transient side effect profile

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

next-generation vaccines for serious infectious diseases, today announced

preliminary data demonstrating that a single booster dose of its recombinant

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

NVX-CoV2373, given six months after an initial two-dose regimen, elicited a

4.6-fold increase in functional antibody titers. Additionally, functional ACE-2

binding inhibition antibodies cross-reactive with the Delta (B.1.617.2) variant

were more than 6-fold higher than the primary vaccination series. Complete data

from the study will be submitted to a peer review publication and posted to a

preprint server.

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The results come from an ongoing Phase 2 study in the U.S. and Australia in

which select participants in the 5-microgram dose cohort received a 5-microgram

booster dose 189 days after the initial two-dose regimen to examine the

functional immune response.

"The strong results from this study reinforce our confidence in the potential

for a booster dose of NVX-CoV2373 to provide broad protection against disease,

including from known and emerging variants," said Gregory M. Glenn, M.D.,

President of Research and Development, Novavax. "Given the evidence that

natural and vaccine-induced immunity wanes over time, the continuation of our

proactive clinical development program will be critical to understanding and

demonstrating the effectiveness of our recombinant nanoparticle COVID-19

vaccine."

Twenty-eight days following boosting, anti-spike IgG increased approximately

4.6-fold compared to the peak response seen after the second dose (Day 217 GMEU

= 200,408 (95% CI: 159,796; 251,342)). This boosted value represents a 3.7 to

4.4-fold increase in anti-spike IgG values that were associated with protection

in Novavax' PREVENT-19 and U.K. Phase 3 clinical studies.

Similarly, wild-type neutralization responses increased approximately 4.3-fold

compared to the peak response seen after Dose 2 (IC50 neutralization titers =

6,231 (95% CI: 4,738; 8,195)). This boosted value represents a 4.6 to 5.5-fold

increase over the neutralization response associated with protection in the

PREVENT-19 and U.K. Phase 3 clinical trials. Older participants (aged 60-84)

showed a 5.4-fold increase in antibody responses, while younger participants

(aged 18-59) showed a 3.7-fold increase. Very high levels of functional

antibodies to the Alpha (B.1.1.7), Beta (B.1.351) and Delta variants were

induced by boosting with NVX-CoV2373, with a 6.6-fold higher Delta

variant-specific response when compared to the Delta response observed with the

primary vaccination series.

The administration of the booster dose was generally well-tolerated. Local and

systemic reactogenicity increased between Dose 1, Dose 2 and Dose 3, with 90%

of symptoms rated as mild or moderate after the third dose.

In addition to the ongoing Phase 1/2 boost study, NVX-CoV2373 is one of seven

COVID-19 vaccines being evaluated as part of COV-Boost, a "mix-and-match" study

being conducted by the University Hospital Southampton NHS Foundation Trust and

other U.K. National Institute for Health Research sites and supported by the

U.K. Vaccines Task Force and Department of Health and Social Care. COV-Boost is

evaluating heterologous boosting in individuals who previously received two

doses of an authorized vaccine. NVX-CoV2372 is also being evaluated in

Com-COV2, which is exploring heterologous regimen of COVID-19 vaccines from

different manufacturers.

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 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 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°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 (https://c212.net/c/link/?t=0&l=en&o=3251546-1&h=3667673888&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=3251546-1&h=3440254179&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, and the potential for a booster dose of NVX-CoV2373 to

provide broad protection against COVID-19 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; 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

+1-202-709-7521

media@novavax.com

SOURCE: Novavax, Inc.