- 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¡ã- 8¡ã 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

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SOURCE: Novavax, Inc.