PR94734

GAITHERSBURG, Md., March 1, 2022 /PRNewswire =KYODO JBN/ --

- NVX-CoV2373 demonstrates protection against symptomatic and asymptomatic

infection

- High level of vaccine efficacy maintained over a 6-month period of

surveillance

- Continued reassuring safety profile in line with previous trials

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

and commercializing next-generation vaccines for serious infectious diseases,

today shared extended analysis from its pivotal Phase 3 clinical trial

conducted in the United Kingdom (UK), showing that a high level of efficacy for

its protein-based COVID-19 vaccine, NVX-CoV2373, was maintained over a 6-month

period of surveillance. Additionally, the analysis showed vaccine efficacy of

82.5% (95% CI: 75.0, 87.7) in protection against all COVID-19 infection – both

symptomatic and asymptomatic – as measured by PCR+ or anti-N seroconversion.

"These data have two implications for NVX-CoV2373. Importantly, the vaccine

offers protection against symptomatic and asymptomatic COVID-19 infection which

may both interrupt virus transmission and prevent COVID-19 disease," said

Gregory M. Glenn, M.D., President of Research and Development, Novavax.

"Additionally, we are encouraged to see that our COVID-19 vaccine maintains a

high level of durable efficacy and continues to exhibit a reassuring safety

profile in this extended timeframe."

The data build upon the final analysis of the UK Phase 3 trial, published in

the New England Journal of Medicine (

https://c212.net/c/link/?t=0&l=en&o=3457574-1&h=1168123000&u=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2107659&a=New+England+Journal+of+Medicine

) in June 2021, which was used as part of Novavax' regulatory submissions for

NVX-CoV2373 around the world and demonstrated a vaccine efficacy of 89.7% (95%

CI: 80.2, 94.6), with cases collected over three months (median of 55 days of

surveillance).

In the expanded data collection window, vaccine efficacy was evaluated over a

6-month period from November 10, 2020, through May 10, 2021 (median of 101 days

of surveillance). NVX-CoV2373 continued to show a reassuring safety profile

during this window, with adverse events that were balanced between vaccine and

placebo groups. Additionally, the trial demonstrated continued protection with

an overall vaccine efficacy of 82.7% (95% CI: 73.3, 88.8). Vaccine efficacy

against severe disease was 100% (95% CI: 17.9, 100) during the 6-month efficacy

collection window, in line with the initial analysis.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine 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 mcg antigen and 50 mcg 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. Use of the vaccine should

be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization and

distribution of NVX-CoV2373 worldwide. Existing authorizations leverage

Novavax' manufacturing partnership with Serum Institute of India (SII), the

world's largest vaccine manufacturer by volume. They will later be supplemented

with data from additional manufacturing sites throughout Novavax' global supply

chain.

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 harnesses the power and speed of

genetic engineering to efficiently produce highly immunogenic nanoparticles

designed to address urgent global health needs. NVX-CoV2373, the company's

COVID-19 vaccine, has received conditional authorization from multiple

regulatory authorities globally, including the European Commission and the

World Health Organization. The vaccine is also under review by multiple

regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is

also currently evaluating a COVID-seasonal influenza combination vaccine in a

Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its

quadrivalent influenza investigational vaccine candidate. These 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 LinkedIn (

https://c212.net/c/link/?t=0&l=en&o=3457574-1&h=490910999&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3395501-1%26h%3D853375093%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3392093-1%2526h%253D1325598136%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3387216-1%252526h%25253D2935962557%252526u%25253Dhttps%2525253A%2525252F%2525252Fc212.net%2525252Fc%2525252Flink%2525252F%2525253Ft%2525253D0%25252526l%2525253Den%25252526o%2525253D3260461-1%25252526h%2525253D1508558197%25252526u%2525253Dhttps%252525253A%252525252F%252525252Fc212.net%252525252Fc%252525252Flink%252525252F%252525253Ft%252525253D0%2525252526l%252525253Den%2525252526o%252525253D3158017-1%2525252526h%252525253D3702938248%2525252526u%252525253Dhttps%25252525253A%25252525252F%25252525252Fwww.linkedin.com%25252525252Fcompany%25252525252Fnovavax%25252525252F%2525252526a%252525253DLinkedIn%25252526a%2525253DLinkedIn%252526a%25253DLinkedIn%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, including

a COVID-seasonal influenza combination vaccine candidate with NanoFlu, its

quadrivalent influenza investigational vaccine candidate, the scope, timing and

outcome of future regulatory filings and actions, including Novavax' plans

supplement existing authorizations with data from the additional manufacturing

sites in Novavax' global supply chain, the potential impact of Novavax and

NVX-CoV2373 in addressing vaccine access, controlling the pandemic, and

protecting populations, and the efficacy, safety, and intended utilization of

NVX-CoV2373 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

Ali Chartan | 240-720-7804

Laura Keenan Lindsey | 202-709-7521

media@novavax.com

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

SOURCE Novavax, Inc.