Novavax Initiates First Phase 1 Clinical Trial of Its A(H7N9) Influenza Vaccine Candidate

Novavax Initiates First Phase 1 Clinical Trial of Its A(H7N9) Influenza
Vaccine Candidate

ROCKVILLE, Md., July 8, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX)
today announced that enrollment has begun in a Phase 1 clinical trial of its
monovalent virus-like particle (VLP) vaccine candidate for the prevention of
disease due to A/Anhui/1/13-like A(H7N9) avian influenza viruses (A(H7N9)

This Phase 1, randomized, observer-blinded, placebo-controlled trial will
enroll up to 280 eligible adults. Each subject will be randomized into one of
seven treatment groups, including placebo, or varying doses of the A(H7N9)
vaccine, with or without an adjuvant. Each subject will receive two identical
intramuscular doses at Day 0 and Day 21 and undergo study follow-up for
approximately one year after the second dose. All subjects will be evaluated
for safety and immunogenicity.

"Novavax has moved our program rapidly from the A/Anhui/1/13-like (H7N9) viral
gene sequence, to vaccine candidate, into multiple animal studies, and now,
exactly three months after the gene sequence was obtained, into a clinical
trial," said Stan Erck, President and Chief Executive Officer of Novavax. "We
expect to report top-line results from this clinical trial later this year.
This level of performance is a testament to the Novavax technology and the
hard-work and commitment of its people. It serves as a powerful example of the
Company's ability to respond rapidly to any future pandemic event."

About A(H7N9) Influenza

In March 2013, avian-origin A(H7N9) viruses emerged as human pathogens in
Southeastern China. As of 4 July 2013, 133 human cases had been reported to
the WHO from China, including 43 deaths. The majority of these patients were
hospitalized with severe pneumonia, acute respiratory distress syndrome and
multi-organ dysfunction. Immunologic experience with these A(H7N9) viruses had
not been observed previously in the general population. In the event these
viruses gain the ability for efficient and sustained human-to-human
transmission, an influenza pandemic could result, with the potential for high
rates of illness and mortality worldwide. Although it appears that the first
A(H7N9) epidemic has subsided, the presence of a natural reservoir, the lack
of antibodies to A(H7N9) in the general population, the severity of the
disease and the potential for a second wave epidemic suggest an urgent need
for A(H7N9) vaccine development. Vaccines are widely considered to be the
first line of defense for protecting populations in advance of an influenza

About VLPs and Novavax' Vaccine Program

VLPs are self-assembling protein structures that resemble the external
structure of viruses, and when used as antigen in a vaccine, elicit broad and
strong antibody and cellular immune responses, but lack the live genetic
material that causes viral replication and infection. VLPs contain three of
the major virus proteins that are important targets for fighting influenza:
hemagglutinin stimulates the body to produce antibodies that prevent binding
of the influenza virus; neuraminadase induces immunity that prevents viral
spread through the cells in the respiratory tract; and matrix 1 stimulates
cytotoxic T lymphocytes to kill infected cells. VLPs have been and can be
designed quickly to match novel viral strains and be produced efficiently
using portable recombinant cell-culture technology. Novavax' VLP-based vaccine
candidates are produced more rapidly than egg-based vaccines because of our
cell-culture technology platform combined with single-use bioprocessing
technology employed strategically throughout the manufacturing process.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating novel vaccines to address a broad range of infectious diseases
worldwide. Using innovative recombinant protein nanoparticle vaccine
technology, as well as new and efficient manufacturing approaches, the company
produces vaccine candidates to combat diseases, with the goal of allowing
countries to better prepare for and more effectively respond to rapidly
spreading infections. Novavax is committed to using its technology platforms
to create geographic-specific vaccine solutions and is therefore involved in
several international partnerships, including collaborations with Cadila
Pharmaceuticals of India, LG Life Sciences of Korea and PATH. Together, these
organizations support Novavax' worldwide commercialization strategy and have
the global reach to create real and lasting change in the biopharmaceutical
field. Additional information about Novavax is available on the company's

Forward Looking Statements

Statements herein relating to the future of Novavax and its ongoing
development of its vaccine 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, 2012, and filed
with the Securities and Exchange Commission. We caution investors not to place
considerable reliance on the forward-looking statements contained in this
press release. You are encouraged to read our filings with the SEC, available
at, 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

CONTACT: Barclay Phillips
         SVP, Chief Financial Officer and Treasurer
         Novavax, Inc.
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