New England Journal of Medicine Publishes Positive Data From Clinical Trial of Novavax' Vaccine Against H7N9 Avian Flu

New England Journal of Medicine Publishes Positive Data From Clinical Trial of
Novavax' Vaccine Against H7N9 Avian Flu

  *Data are industry's first from clinical trial of vaccine against A(H7N9)
    strain of influenza
  *81% of 5ug adjuvanted vaccine recipients had protective HAI levels
  *97% of 5ug adjuvanted vaccine recipients had anti-neuraminidase antibody
  *Protective levels achieved from vaccinations within 116 days of the
    announced outbreak of novel lethal H7N9 virus
  *Dose-sparing formulation shows significant potential utility in the event
    of a pandemic
  *Vaccine safety consistent with previously tested adjuvanted pandemic

ROCKVILLE, Md., Nov. 13, 2013 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX)
today announced that positive clinical data for the company's virus-like
particle (VLP) vaccine candidate against A(H7N9) influenza were published
online in the Correspondence section of The New England Journal of Medicine.
The correspondence can be found at: and will appear in the
December 26, 2013 print edition.

The study, conducted in 284 adult male and female subjects, examined the
safety and immunogenicity of two administrations of Novavax' A(H7N9) VLP
vaccine candidate on day 0 and day 21. Subjects were administered either
placebo, 15 or 45 µg of vaccine alone, or 5 or 15µg of vaccine with either 30
or 60 ISCO^® units of the saponin-based ISCOMATRIX^® adjuvant, developed by
CSL Limited in Australia. Serology was assessed at Days 0, 21 and 35
post-first immunization.

The Novavax A(H7N9) VLP vaccine candidate was generally well tolerated, and
the safety was in line with the company's previous findings with its influenza
VLP antigens using ISCOMATRIX^® adjuvant. Overall, as with other adjuvanted
influenza vaccines, there was an increase in transient local and systemic
reactions in the adjuvanted in contrast to the non-adjuvanted formulations,
but there were no treatment-related SAEs in the active groups. The A(H7N9) VLP
vaccine candidate induced hemagglutination-inhibition (HAI) antibody titers of
≥1:40 (seroprotection) and a four-fold HAI antibody rise (serconversion)
against H7N9 in 81% of subjects at the 5mg dose of A(H7N9) antigen with 60
ISCO^® units of adjuvant, and 73% of subjects receiving 5mg dose of A(H7N9)
antigen with either adjuvant dose level. The vaccine also elicited
anti-neuraminidase (NA) antibodies against N9 in 92 to 97% of subjects
receiving 5mg with either adjuvant dose level.

The A(H7N9) influenza strain has emerged recently as a potential pandemic
concern. Less than ten (10) days after the Chinese Health authorities
announced an outbreak of this novel avian influenza in humans (137 total
confirmed cases, including 45 deaths, to date), Novavax obtained the genetic
sequence of the strain and commenced production of a recombinant vaccine.
Clinical trial material was manufactured and released in late June 2013 with
the first doses injected in humans in early July 2013. Less than four months
after the novel A(H7N9) virus had been identified and sequenced, Novavax' H7N9
VLP vaccine, with the higher-dose of ISCOMATRIX® adjuvant, has achieved immune
responses likely to be protective in 81% of recipient subjects with as little
as 5µg of antigen.

"The production and testing of a vaccine for a novel, lethal influenza virus
in such a short time period validates the agility of Novavax' technology in
addressing pandemic threats," said Dr. Lou Fries, the company's Vice President
of Clinical and Medical Affairs. "The performance of our vaccine candidate is
particularly important in light of the speed with which pandemic outbreaks can
unfold. Often, an initial outbreak of a novel influenza virus is followed by a
more severe and widespread outbreak at the onset of the next fall and winter
respiratory virus season, as seen in 2009 with H1N1. Unfortunately, vaccine
makers in 2009 were unable to produce vaccine in advance of the second wave
and there was little impact of vaccine upon H1N1 disease in the first year.
Past H7-based vaccine candidates have been poorly immunogenic and thus could
not be advanced as viable vaccine candidates. This risk appears to have been
overcome by our H7N9 adjuvanted VLP vaccine."

Stanley C. Erck, President and Chief Executive Officer of Novavax, added, "As
evidenced by our correspondence in The New England Journal of Medicine, this
is a critical accomplishment for pandemic preparedness. Building on the
positive clinical results with our H5N1 VLP vaccine candidate from last
October, these recently gathered data from our A(H7N9) influenza vaccine give
further confirmation that the Novavax vaccine platform deserves to play a key
role in addressing evolving pandemic threats. We have used recombinant VLP
technology to demonstrate that timely responses are possible, and we are proud
to be the first company to produce a viable H7N9 vaccine. Furthermore, we are
pleased that HHS-BARDA has recognized this achievement and asked us to focus
our pandemic vaccine development under our HHS-BARDA contract on our H7N9
vaccine candidate."

About H7N9 Avian Flu

Following recognition of the first human infections with avian-origin
influenza A(H7N9) and their attendant severity in March 2013, public health
officials from around the world called for immediate and preemptive
development of surveillance, diagnostic and clinical intervention tools in the
event that the A(H7N9) virus becomes transmissible among humans. According to
Keiji Fukuda of the WHO, there is high concern over potential for A(H7N9) to
gain sustainable person-to-person transmissibility. He noted that over a
two-month period in China, as many H7N9 cases occurred as caused by H5N1 cases
over 10 years. Additionally, molecular genetic changes occurred, suggesting
adaptation of the virus to humans. After a quiescent period during the summer
months, four new cases of human A(H7N9) disease have been reported since
October 7, prompting concerns and expectations over the virus reemerging in
human populations in the coming winter season.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using innovative proprietary recombinant
protein nanoparticle vaccine technology, the company produces vaccine
candidates to efficiently and effectively respond to both known and newly
emergent diseases. Novavax is involved in several international partnerships,
including collaborations with Cadila Pharmaceuticals of India, LG Life
Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine
adjuvant company located in Sweden. Together, Novavax' network supports its
global commercialization strategy to create real and lasting change in the
biopharmaceutical and vaccinology fields. Additional information about Novavax
is available on the company's website,

About ISCOMATRIX^® adjuvant

ISCOMATRIX^® adjuvant is made from saponin, cholesterol and phospholipid
which, under defined conditions, form cage-like structures typically 40-50nm
in diameter. The optimized ISCOMATRIX^® adjuvant is well defined, has minimal
impurities and does not use any materials of animal origin. Additionally,
improvements have been made to the manufacturing processes to ensure it can be
reproduced on a large scale. ISCOMATRIX^® adjuvant is currently manufactured
at commercial scale at CSL's facility in Kankakee, Illinois.

Forward-Looking Statements

Statements herein relating to the future of Novavax and the ongoing
development of its vaccine and adjuvant 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 Form 10-Q for the period ended June 30, 2013, both filed with the
Securities and Exchange Commission (SEC). 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 uncertainties.

CONTACT: Barclay A. Phillips
         Senior Vice President, Chief Financial Officer
         Novavax, Inc.
         David Schull or Andrea Flynn, Ph.D.
         Russo Partners, LLC

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