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Novavax, Inc.: Novavax Announces Positive Top-Line Data From RSV F Vaccine Phase 1 Clinical Trial in Pediatrics

Novavax' Fifth Positive Top-Line Clinical Trial Announcement of the 3rd QuarterGAITHERSBURG, Md., Sept. 29, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc.,
(Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery,
development and commercialization of recombinant nanoparticle vaccines and
adjuvants, today announced positive top-line data from a Phase 1 clinical
trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F
Vaccine) in healthy children.

The trial was a randomized, observer-blinded, Phase 1 study to evaluate the
safety and immunogenicity of the RSV F Vaccine, with one or two doses, with
or without aluminum phosphate adjuvant, in healthy pediatric participants two
to six years of age. The trial's primary goal was to evaluate safety in this
population and immunogenicity as measured by concentrations of serum IgG
antibodies to the RSV fusion, or F-protein, palivizumab-competing antibody
(PCA) titers and RSV microneutralization titers. Novavax concluded this
trial's enrollment with a smaller than planned cohort so dosing could be
completed ahead of the 2014-2015 RSV season.

Of the 32 total children enrolled, serum samples were collected from a subset
of 18 children in the per-protocol population at 14, 28 and 56 days. All RSV
F Vaccine formulations and regimens were well-tolerated and highly
immunogenic. Consistent with prior trials, anti-F IgG and PCA titers
increased rapidly at day 14, peaked at day 28 and remained at elevated levels
through day 56; the last time point currently analyzed. There were greater
than 10-fold increases in both anti-F IgG and PCA antibody titers in the
adjuvanted group and greater than 6-fold increases in anti-F IgG and PCA
antibody titers in the unadjuvanted group.

"Given the seasonality of RSV and the fact that infection could confound
interpretation of the data, we closed out the trial prior to the initiation
of the RSV season. Despite the small population, we were able to observe that
the vaccine has the potential to be both safe and immunogenic in young
children," said Gregory Glenn, M.D., Senior Vice President, Research and
Development. "The strength of these data clearly support advancing the RSV
vaccine into a Phase 2 pediatric trial."

"Our RSV F Vaccine has now elicited a robust immune response in all three of
our target populations: older adults, infants via maternal immunization and
pediatrics. We are evaluating this data in the context of our RSV F Vaccine
overall clinical development program and look forward to providing an update
in the next several months on our path forward in the pediatric population,"
said Stanley C. Erck, President and CEO. "It should not be lost on those
interested in Novavax that this announcement is the fifth positive clinical
trial readout provided during the third quarter of this year, a pivotal
achievement for the Company made possible by the power of our recombinant
nanoparticle platform technology and this dedicated and experienced team."

About RSV

Respiratory syncytial virus (RSV) is the most common cause of lower
respiratory tract infections and the leading viral cause of severe lower
respiratory tract disease in infants and young children worldwide, with
estimated annual infection and mortality rates of 64 million and 160,000,
respectively1. In the US, RSV is the leading cause of hospitalization of
infants2. Despite the induction of post-infection immunity, repeat infection
and lifelong susceptibility to RSV is common3,4. Currently, there is no
approved RSV vaccine available. Palivizumab is a monoclonal antibody,
licensed and sold by MedImmune as Synagis®, that targets the RSV F protein
and is used for prophylaxis against RSV disease in high risk infants.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to
delivering novel products to prevent a broad range of infectious diseases.
Our recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the
foundation for groundbreaking innovation that improves global health through
safe and effective vaccines. Additional information about Novavax is
available on the company's website,novavax.com.


1. Nair, H.et al.
Global burden of acute lower respiratory infections due to respiratory
syncytial virus in young children: a systematic review and
, 2010; 375: 1545-1555.

2. Hall, C.B.et al.
Respiratory Syncytial Virus-Associated hospitalizations Among Children Less
Than 24 Months of Age.Pediatrics
, 2013; 132(2): E341-348.

3. Glezen, W.P.et al.
Risk of primary infection and reinfection with respiratory syncytial virus.Am
J Dis Child
, 1986; 140:543-546.

4. Glenn GM,et al.
Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea
2015; In press. http://dx.doi.org/10.1016/j.vaccine.2015.08.039.


Novavax, Inc.

Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer

Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations


Russo Partners, LLC

David Schull
Todd Davenport, Ph.D.



This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novavax, Inc. via Globenewswire


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