- New safety and immunogenicity data for the COVID-19-Influenza
Combination vaccine candidate Phase 1/2 trial will be
presented
- New data will be presented for Novavax' COVID-19 vaccine
supporting its use as a homologous and heterologous booster in
adults aged 18 and older and adolescents aged 12 through 17
- Updated Phase 3 PREVENT-19 data and new Study 307: Lot
Consistency data will reinforce COVID-19 vaccine's benefits as an
adult heterologous booster
GAITHERSBURG, Md., Oct. 10, 2022 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, will present new safety and immunogenicity data from the
first Phase 1/2 COVID-Influenza Combination (CIC) dose-finding
trial evaluating its CIC vaccine candidate at the World Vaccine
Congress (WVC) Europe,
October 11 to 14, 2022. Data from the
Phase 3 PREVENT-19 trial and from Study 307: Lot Consistency
evaluating the protein-based Novavax COVID-19 vaccine (NVX-CoV2373)
as a booster both in adults aged 18 and older and in adolescents
aged 12 through 17 will also be presented.
"Data presented at WVC will show the continued momentum of our
COVID-19 vaccine as a booster and also provide insight into our
COVID-19-Influenza Combination vaccine candidate's immunogenicity,
safety, and optimal dose," said Gregory
Glenn, M.D., President of Research and Development at
Novavax. "Novavax is focused on developing innovative vaccines
built on a well-established technology and we are committed to
building a portfolio of best-in-class vaccines across multiple
infectious disease areas."
In addition to the data presentations, Dr. Glenn will
participate in a keynote panel to discuss the future of COVID-19
vaccines and next steps in addressing the pandemic.
Novavax presentations during WVC
Europe:
Author
|
Presentation
title
|
Details
|
Glenn,
G
|
The future of COVID
vaccination in the human population – What's the end game and how
do we exit from the public health emergency?
|
Keynote
Panel
October 12,
2022
8:30 – 9:30am
(CEST)
|
Áñez, G
Bennett, C
|
Paving the way for
Protein: Novavax's COVID-19 Vaccine as a Booster,
Variant-adapted
|
Oral
Presentation
October 12,
2022
05:00 – 5:30pm
(CEST)
|
Shinde, V
|
Update on Novavax
Investigational Influenza vaccine and COVID-19-INFLUENZA
Combination Vaccine development
|
Oral
Presentation
October 13,
2022
2:30 – 3:00pm
(CEST)
|
For more information, visit the World Vaccine Congress Europe
2022 website.
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. The Novavax COVID-19 vaccine has received
authorization from multiple regulatory authorities globally,
including the U.S. Food and Drug Administration, the European
Commission, and the WHO. The vaccine is currently under review by
multiple regulatory agencies worldwide, including for additional
populations and indications such as adolescents and as a booster.
In addition to its COVID-19 vaccine, Novavax is also currently
evaluating its COVID-19-Influenza Combination vaccine candidate in
a Phase 1/2 clinical trial, its quadrivalent influenza
investigational vaccine candidate, and an Omicron strain-based
vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based /
original strain-based vaccine. These vaccine candidates incorporate
Novavax' proprietary saponin-based Matrix-M 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 LinkedIn.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, its
partnerships, the timing of clinical trial results, the
ongoing development of NVX-CoV2373, including an Omicron strain
based vaccine and bivalent Omicron-based / original strain based
vaccine, a COVID-seasonal Influenza Combination investigational
vaccine candidate, the scope, timing and outcome of future
regulatory filings and actions, including Novavax' plans to
supplement existing authorizations with data from the additional
manufacturing sites in Novavax' global supply chain, additional
worldwide authorizations of NVX-CoV2373 for use in adults and
adolescents, and as a booster, the potential impact and reach of
Novavax and NVX-CoV2373 in addressing vaccine access, controlling
the pandemic and protecting populations, the efficacy, safety
intended utilization, and the expected administration 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, without limitation, 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; unanticipated challenges or
delays in conducting clinical trials; 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, 2021 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
Erika Schultz |
240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
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