GAITHERSBURG, Md., Feb. 28, 2022 /CNW/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today shared extended analysis from its pivotal Phase 3
clinical trial conducted in the United
Kingdom (UK), showing that a high level of efficacy for its
protein-based COVID-19 vaccine, NVX-CoV2373, was maintained over a
6-month period of surveillance. Additionally, the analysis showed
vaccine efficacy of 82.5% (95% CI: 75.0, 87.7) in protection
against all COVID-19 infection – both symptomatic and asymptomatic
– as measured by PCR+ or anti-N seroconversion.
"These data have two implications for NVX-CoV2373. Importantly,
the vaccine offers protection against symptomatic and asymptomatic
COVID-19 infection which may both interrupt virus transmission and
prevent COVID-19 disease," said Gregory M. Glenn, M.D.,
President of Research and Development, Novavax. "Additionally, we
are encouraged to see that our COVID-19 vaccine maintains a high
level of durable efficacy and continues to exhibit a reassuring
safety profile in this extended timeframe."
The data build upon the final analysis of the UK Phase 3 trial,
published in the New England Journal of
Medicine in June 2021, which
was used as part of Novavax' regulatory submissions for NVX-CoV2373
around the world and demonstrated a vaccine efficacy of 89.7% (95%
CI: 80.2, 94.6), with cases collected over three months (median of
55 days of surveillance).
In the expanded data collection window, vaccine efficacy was
evaluated over a 6-month period from November 10, 2020, through May 10, 2021 (median of 101 days of
surveillance). NVX-CoV2373 continued to show a reassuring safety
profile during this window, with adverse events that were balanced
between vaccine and placebo groups. Additionally, the trial
demonstrated continued protection with an overall vaccine efficacy
of 82.7% (95% CI: 73.3, 88.8). Vaccine efficacy against severe
disease was 100% (95% CI: 17.9, 100) during the 6-month efficacy
collection window, in line with the initial analysis.
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™
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°- 8° Celsius, enabling the use of existing vaccine
supply and cold chain channels. Use of the vaccine should be in
accordance with official recommendations.
Novavax has established partnerships for the manufacture,
commercialization and distribution of NVX-CoV2373 worldwide.
Existing authorizations leverage Novavax' manufacturing partnership
with Serum Institute of India
(SII), the world's largest vaccine manufacturer by volume. They
will later be supplemented with data from additional manufacturing
sites throughout Novavax' global supply chain.
About Matrix-M™ Adjuvant
Novavax' patented
saponin-based Matrix-M™ 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, has
received conditional authorization from multiple regulatory
authorities globally, including the European Commission and the
World Health Organization. The vaccine is also under review by
multiple regulatory agencies worldwide. In addition to its COVID-19
vaccine, Novavax is also currently evaluating a COVID-seasonal
influenza combination vaccine in a Phase 1/2 clinical trial, which
combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza
investigational vaccine candidate. 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 ongoing development of NVX-CoV2373, including a
COVID-seasonal influenza combination vaccine candidate with
NanoFlu, its quadrivalent influenza investigational vaccine
candidate, the scope, timing and outcome of future regulatory
filings and actions, including Novavax' plans supplement existing
authorizations with data from the additional manufacturing sites in
Novavax' global supply chain, the potential impact of Novavax and
NVX-CoV2373 in addressing vaccine access, controlling the pandemic,
and protecting populations, 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 | 240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey |
202-709-7521
media@novavax.com
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SOURCE Novavax, Inc.