PR88476

GAITHERSBURG, Md., March 12, 2021 /PRNewswire=KYODO JBN/ --

- 100% protection against severe disease

- Final analysis in U.K. trial confirms 96% efficacy against original strain of

COVID-19

- Efficacy against variants confirmed in U.K. and South Africa

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

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

efficacy of 96.4% against mild, moderate and severe disease caused by the

original COVID-19 strain in a pivotal Phase 3 trial in the United Kingdom

(U.K.) of NVX-CoV2373, the company's vaccine candidate. The company also

announced the complete analysis of its Phase 2b trial taking place in South

Africa, with efficacy of 55.4% among the HIV- negative trial participants in a

region where the vast majority of strains are B1.351 escape variants. Across

both trials, NVX-CoV2373 demonstrated 100% protection against severe disease,

including all hospitalization and death. Both studies achieved their

statistical success criteria. Today's final analyses build on the successful

interim results announced (

https://c212.net/c/link/?t=0&l=en&o=3094828-1&h=892322279&u=https%3A%2F%2Fir.novavax.com%2Fnews-releases%2Fnews-release-details%2Fnovavax-announces-initiation-prevent-19-pivotal-phase-3-efficacy&a=announced

) in January 2021, adding substantially more COVID-19 cases and statistical

power.

"We are very encouraged by the data showing that NVX-CoV2373 not only provided

complete protection against the most severe forms of disease, but also

dramatically reduced mild and moderate disease across both trials. Importantly,

both studies confirmed efficacy against the variant strains," said Stanley C.

Erck, President and Chief Executive Officer, Novavax. "Today marks one year

since the WHO officially declared the COVID-19 pandemic, and with this data in

hand, we are even more motivated to advance our vaccine as a potential weapon

in the fight to end the suffering caused by COVID-19."

United Kingdom Phase 3 Trial

The study enrolled more than 15,000 participants between 18-84 years of age,

including 27% over the age of 65. The primary endpoint of the U.K. Phase 3

clinical trial is based on the first occurrence of PCR-confirmed symptomatic

(mild, moderate or severe) COVID-19 with onset at least 7 days after the second

study vaccination in serologically negative (to SARS-CoV-2) adult participants

at baseline.

Efficacy was 96.4% (95% CI: 73.8, 99.5) against the original virus strain and

86.3% (95% CI: 71.3, 93.5) against the B.1.1.7/501Y.V1 variant circulating in

the U.K (post hoc). The primary efficacy endpoint demonstrated an overall

vaccine efficacy of 89.7% (95% CI: 80.2, 94.6). 106 cases were observed, with

10 in the vaccine group and 96 in the placebo group. NVX-CoV2373 was effective

against severe disease: five severe(1) cases were observed in the study, and

all occurred in the placebo group. Four of the five severe cases were

attributed to the B.1.1.7/501Y.V1 variant. Fourteen days after dose 1, vaccine

efficacy was 83.4% (95% CI: 73.6, 89.5).

In volunteers 65 years of age and older, 10 cases of COVID-19 were observed,

with 90% of those cases occurring in the placebo group. Older adults are among

the groups most impacted by the disease and are at high risk of complications

from COVID-19.

Novavax expects the data to serve as the basis for submission for authorization

to various regulatory agencies worldwide.

South Africa Phase 2b Trial

The South Africa trial was a randomized, observer-blinded, placebo-controlled

Phase 2b clinical trial of NVX-CoV2373. One cohort evaluated efficacy, safety

and immunogenicity in approximately 2,665 healthy adults. The second cohort

evaluated safety and immunogenicity in approximately 240 medically stable,

HIV-positive adults.

A complete analysis of vaccine efficacy among 147 PCR-positive cases (51 cases

in the vaccine group and 96 in the placebo group) demonstrated an overall

efficacy of 48.6% against predominantly variant strains (95% CI: 28.4, 63.1).

The vast majority of cases circulating during the efficacy analysis were due to

the B.1.351/501Y.V2 variant circulating in South Africa. All five cases of

severe disease observed in the trial occurred in the placebo group. Among

HIV-negative participants, 55.4% efficacy was observed (95% CI: 35.9, 68.9).

The complete analysis shows that vaccine-induced protection began 14 days after

dose 1 (42.7% 95% CI: 25.0, 56.3), although increased efficacy was observed 7

days after dose 2, the primary endpoint for the study.

A previously reported initial analysis from the study through 60 days indicated

that prior infection with the original COVID-19 strain might not completely

protect against subsequent infection by the variant predominantly circulating

in South Africa. However, the complete analysis of the South Africa trial

indicates that there may be a late protective effect of prior exposure with the

original COVID-19 strain. In placebo recipients, at 90 days the illness rate

was 7.9% in baseline seronegative individuals, with a rate of 4.4% in baseline

seropositive participants.

In both the U.K. and South Africa trials, these analyses showed that the

vaccine is well-tolerated, with low levels of severe, serious (SAEs) and

medically attended adverse events at day 35, balanced between vaccine and

placebo groups.

For further information, including media-ready images, b-roll, downloadable

resources and more, click here (

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).

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic

sequence 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 block binding of spike

protein to cellular receptors and provided protection from infection and

disease. It was generally well-tolerated and elicited robust antibody response

numerically superior to that seen in human convalescent sera 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 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: a Phase 2b trial in South Africa that

demonstrated 48.65% efficacy against a newly emerging escape variant, 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 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 (

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) and LinkedIn (

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).

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, 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.

(1) Please see trial protocols for endpoint definitions of COVID-19 severity at

https://www.novavax.com/resources#protocols

SOURCE Novavax, Inc.

CONTACT: Investors - Novavax, Inc. Erika Schultz | 240-268-2022,

ir@novavax.com, or Solebury Trout - Jennifer Porcelli | +1-617-974-8659,

jporcelli@soleburytrout.com; Media - Laura Keenan | +1-410-419-5755, or Amy

Speak | +1-617-420-2461, media@novavax.com