- Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune 
responses against Omicron (B.1.1.529) and other variants

- Third dose produced increased immune responses comparable to or exceeding 
levels associated with protection in Phase 3 clinical trials, with a 9.3-fold 
IgG rise and a 19.9-fold ACE2 inhibition increase after booster dose

- Immune responses in adolescents were 2- to 4-fold higher than adults against 
broad array of variants of interest and variants of concern 

- Development of Omicron-specific vaccine on track for initiation of GMP 
manufacturing in early January

- Company to host investor conference call today from 4:30 - 5:00 pm ET

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing 
and commercializing next-generation vaccines for serious infectious diseases, 
today announced initial data evaluating the immune response of its COVID-19 
vaccine, NVX-CoV2373, against the Omicron variant as well as additional data 
from its ongoing Phase 2 boost study. New results demonstrate broad 
cross-reactivity against Omicron and other circulating variants from a primary 
2-dose regimen, with responses that increased following a third dose at six 
months. 

Immune responses included the following: 
    - Anti-spike IgG titers after Dose 3 increased 5.4-fold (prototype) to 
      9.3-fold (Omicron) from peak responses seen after 2-dose primary 
      vaccination. 
        - This represents a 61.1-fold (prototype) and a 73.5-fold (Omicron) 
          increase from prior to the Dose 3 boost.
    - ACE2-inhibition titers increased 6-fold (prototype) to 19.9-fold 
      (Omicron) compared to peak responses following 2-dose primary series, 
      representing a 54.4-fold (prototype), a 24.4-fold (Delta) and a 
      36.3-fold (Omicron) increase from prior to the booster. 
    - Wild-type neutralization responses were observed after 2 doses for 
      prototype, Delta and Omicron. Significant increases were observed 
      after boosting, with titers for Delta and Omicron comparable to levels 
      associated with protection in U.S. and Mexico and U.K. Phase 3 studies. 
        - After 2 doses, Omicron wild-type neutralization was <4-fold lower 
          than prototype, suggesting that both a booster dose as well as an 
          Omicron-specific vaccine may be beneficial.

Further, data from the pediatric expansion of Novavax' PREVENT-19 Phase 3 trial 
in the U.S. and Mexico showed robust immune responses in adolescents, including 
increased IgG and receptor inhibition titers against a wide array of variants, 
including Omicron, following a 2-dose series. Responses in adolescents were 2- 
to 4-fold higher than adults against all evaluated variants.

"In the midst of an evolving pandemic, NVX-CoV2373 showed strong immune 
responses against Omicron and other circulating variants. We are encouraged 
that boosted responses against all variants were comparable to those associated 
with high vaccine efficacy in our Phase 3 clinical trials, suggesting that 
NVX-CoV2373 can play an important role in the ongoing fight against new 
variants," said Gregory M. Glenn, President of Research and Development, 
Novavax. "Given the continued evolution of the coronavirus, the development of 
an Omicron vaccine could be necessary. Novavax has cloned, expressed and 
characterized the Omicron spike protein vaccine and will soon enter the 
GMP-phase of production. We expect to begin clinical studies in the first 
quarter of 2022."

As part of an ongoing study, a single booster dose of 5 µg SARS-CoV-2 rS with 
50 µg Matrix-M(TM) adjuvant was administered to healthy adult participants 
approximately six months after their primary 2-dose vaccination series. 
Multiple assays were used to evaluate immune responses against SARS-CoV-2 
twenty-eight days following the booster dose.

Safety reporting of reactogenicity events showed an increasing trend across all 
3 doses of NVX-CoV2373, reflecting the increased immunogenicity seen with a 
third dose. Following the booster, local and systemic reactions were generally 
short-lived with a median duration of approximately 2 days. The incidence of 
Grade 3 or higher events remained relatively low. Medically attended adverse 
events (MAAEs), potentially immune-mediated medical conditions (PIMMCs), and 
severe adverse events (SAEs) occurred infrequently following the booster dose 
and were balanced between vaccine and placebo groups.

The major findings, detailed in 'Immunogenicity and Safety Following a 
Homologous Booster Dose of a SARS-CoV-2 recombinant spike protein vaccine 
(NVX-CoV2373): A Phase 2 Randomized Placebo-Controlled Trial,' will be 
submitted for peer-review publication and are expected to be available online 
at https://www.medrxiv.org/ in the coming days.

Conference Call 
Novavax will host a conference call for investors today at 4:30 p.m. ET. The 
dial-in numbers for the conference call are (877) 870-4263 (Domestic) or (412) 
317-0790 (International). Participants will be prompted to request to join the 
Novavax, Inc. call. A replay of the conference call will be available starting 
at 7:30 p.m. ET on December 22, 2021 until 11:59 p.m. ET on December 31, 2021. 
To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 
317-0088 (International) and use passcode 6207101.  

A webcast of the conference call can also be accessed on the Novavax website at 
novavax.com/events ( 
https://c212.net/c/link/?t=0&l=en&o=3398108-1&h=1075217627&u=https%3A%2F%2Fprotect-us.mimecast.com%2Fs%2F0gHHC82A7pCjjZZvcwd3d-%3Fdomain%3Dnovavax.com&a=novavax.com%2Fevents 
). A replay of the webcast will be available on the Novavax website until March 
22, 2022.

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. The current assigned 
shelf life of the vaccine is 9 months.

Novavax has established partnerships for the manufacture, commercialization and 
distribution of NVX-CoV2373 worldwide.

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

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 the New England Journal of Medicine (NEJM).

PREVENT-19, a trial in the U.S. and Mexico, with 25,452 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 in both studies. Full results of the trial were published in NEJM ( 
https://c212.net/c/link/?t=0&l=en&o=3398108-1&h=3418979782&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3395501-1%26h%3D882705254%26u%3Dhttps%253A%252F%252Fwww.nejm.org%252Fdoi%252Ffull%252F10.1056%252FNEJMoa2107659%26a%3DNEJM&a=NEJM 
).

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, 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. 
NanoFlu(TM), the company's quadrivalent influenza nanoparticle vaccine, met all 
primary objectives in its pivotal Phase 3 clinical trial in older adults. 
Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 
1/2 clinical trial, which combines the company's NVX-CoV2373 and NanoFlu 
vaccine candidates. 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 Twitter ( 
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), LinkedIn ( 
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), Instagram ( 
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) and Facebook( 
https://c212.net/c/link/?t=0&l=en&o=3398108-1&h=3831569020&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3394048-1%26h%3D3341622150%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3392093-1%2526h%253D2234833677%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D3387216-1%252526h%25253D4091724087%252526u%25253Dhttps%2525253A%2525252F%2525252Fwww.facebook.com%2525252FNovavax%2525252F%252526a%25253DFacebook%2526a%253DFacebook%26a%3DFacebook&a=Facebook 
).

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 submit a complete CMC data package to the U.S. FDA by the end of the 
year, 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 | +1 240-268-2022 
ir@novavax.com

Solebury Trout 
Alexandra Roy | +1 617-221-9197 
aroy@soleburytrout.com

Media 
Ali Chartan | +1 240-720-7804 
Laura Keenan Lindsey | +1 202-709-7521 
media@novavax.com

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SOURCE: Novavax, Inc.