PR94342

GAITHERSBURG, Md., Jan. 31, 2022 /PRNewswire=KYODO JBN/ --

- NVX-CoV2373 demonstrated overall efficacy of ~90% in PREVENT-19 clinical

trial conducted during the emergence of variant strains

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

and commercializing next-generation vaccines for serious infectious diseases,

today announced that it has submitted a request to the U.S Food and Drug

Administration (FDA) for Emergency Use Authorization (EUA) for NVX-CoV2373, its

protein-based COVID-19 vaccine candidate for immunization of individuals 18

year of age and older against SARS-CoV-2.

The request for EUA is based on the totality of pre-clinical, clinical and

manufacturing-related (CMC) data provided to the agency, including results of

two large pivotal clinical trials that demonstrated an overall efficacy of

approximately 90 percent and a reassuring safety profile.

"We're extremely proud of the work of our teams and we look forward to FDA's

review of our EUA request. We believe our vaccine offers a differentiated

option built on a well-understood protein-based vaccine platform that can be an

alternative to the portfolio of available vaccines to help fight the COVID-19

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

Novavax. "I'd like to also extend our thanks for the support of the U.S.

Department of Health and Human Services and the U.S. Department of Defense for

their partnership leading up to today's milestone of EUA request submission."

Novavax conducted two pivotal Phase 3 clinical trials: PREVENT-19 which

enrolled approximately 30,000 participants in the U.S. and Mexico and published

results in the New England Journal of Medicine

(https://c212.net/c/link/?t=0&l=en&o=3428978-1&h=4185830657&u=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2116185%3Fquery%3Dfeatured_home&a=New+England+Journal+of+Medicine) (NEJM) and a trial with almost 15,000 participants in the U.K. which was also

published in NEJM (https://c212.net/c/link/?t=0&l=en&o=3428978-1&h=889537351&u=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2107659&a=NEJM). In both trials, the vaccine demonstrated efficacy with a reassuring safety

profile. Serious and severe adverse events were low in number and balanced

between vaccine and placebo groups. The most common adverse reactions observed

during clinical studies (frequency category of very common ¡Ý1/10) were

headache, nausea or vomiting, myalgia, arthralgia, injection site

tenderness/pain, fatigue, and malaise. Novavax will continue to collect and

analyze real-world data, including the monitoring of safety and the evaluation

of variants, as the vaccine is distributed in authorized markets. As part of

the PREVENT-19 trial, a booster study is ongoing to evaluate the safety and

effectiveness of a third does of the vaccine, as well as a study in adolescents

aged 12-17.

NVX-CoV2373 has been granted conditional authorization by multiple regulatory

agencies worldwide, including the European Commission, and emergency use

listing (EUL) from the World Health Organization

(https://c212.net/c/link/?t=0&l=en&o=3428978-1&h=1252681756&u=https%3A%2F%2Fir.novavax.com%2F2021-12-20-World-Health-Organization-Grants-Second-Emergency-Use-Listing-for-Novavax-COVID-19-Vaccine&a=World+Health+Organization) (WHO), with additional filings currently under review.

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¡a- 8¡a 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 the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.

PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000

participants, achieved 90.4% efficacy overall. It was designed as a 2:1

randomized, placebo-controlled, observer-blinded study to evaluate the

efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for

PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild,

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

in serologically negative (to SARS-CoV-2) adult participants at baseline. The

statistical success criterion included a lower bound of 95% CI >30%. The key

secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or

severe COVID-19. Both endpoints were assessed at least seven days after the

second study vaccination in volunteers who had not been previously infected

with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody

response after the second dose in both studies. Full results of the trial were

published in the New England Journal of Medicine

(https://c212.net/c/link/?t=0&l=en&o=3428978-1&h=4185830657&u=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2116185%3Fquery%3Dfeatured_home&a=New+England+Journal+of+Medicine) (NEJM).

A trial conducted in the U.K. with 14,039 participants was designed as a

randomized, placebo-controlled, observer-blinded study and achieved overall

efficacy of 89.7%. The primary endpoint was 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. Full results of the trial were

published in NEJM (https://c212.net/c/link/?t=0&l=en&o=3428978-1&h=889537351&u=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2107659&a=NEJM).

PREVENT-19 is being conducted with support from the U.S. government, including

the Department of Defense, the Biomedical Advanced Research and Development

Authority (BARDA), part of the Office of the Assistant Secretary for

Preparedness and Response at the U.S. Department of Health and Human Services

(HHS), and the National Institute of Allergy and Infectious Diseases (NIAID),

part of the National Institutes of Health (NIH) at HHS. BARDA is providing up

to $1.75 billion under a Department of Defense agreement.

About Matrix-M(TM) Adjuvant

Novavax' patented saponin-based Matrix-M(TM) adjuvant has demonstrated a potent

and generally 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, received Conditional Marketing Authorization from the

European Commission, Emergency Use Listing from the World Health Organization,

Emergency Use Authorization in Indonesia and the Philippines, and has been

submitted for regulatory authorization in multiple markets globally.

For more information, visit www.novavax.com and connect with us LinkedIn

(https://c212.net/c/link/?t=0&l=en&o=3428978-1&h=2646657515&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3425721-1%26h%3D1749870132%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, its partnerships, the ongoing development of NVX-CoV2373, the scope,

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

plans to supplement 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, offering an alternative to existing

COVID-19 vaccines, 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.