Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization
PR92859
GAITHERSBURG, Md., Nov. 5, 2021 /PRNewswire=KYODO JBN/ --
-- All modules required for regulatory review of Novavax vaccine, including CMC
data, are now complete for WHO
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced the completion of its rolling submission to the World Health
Organization (WHO) for emergency use listing (EUL) of NVX-CoV2373, its COVID-19
vaccine candidate.
"Today's submission reflects our continued focus on accelerating access and
equitable distribution as we work to bring our vaccine to people in need around
the globe," said Stanley C. Erck, President and Chief Executive Officer,
Novavax. "We continue to work with urgency to deliver our COVID-19 vaccine,
built on a proven, well-understood vaccine platform, because no one is safe
until everyone is safe."
Novavax has now completed the submission to WHO of all modules required for the
regulatory evaluation of NVX-CoV2373, the company's recombinant nanoparticle
protein-based COVID-19 vaccine with Matrix-M(TM) adjuvant. The chemistry,
manufacturing and controls (CMC) module submitted to WHO, as well as other
regulatory agencies worldwide, leverages Novavax' manufacturing partnership
with the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine
manufacturer by volume. Novavax will make further submissions to enable vaccine
supply from additional manufacturing sites in Novavax' global supply chain.
Today's filing by Novavax is in addition to a previous filing to WHO by Novavax
and SII.
The submission also includes clinical data from PREVENT-19, a pivotal Phase 3
trial of 30,000 participants in the U.S. and Mexico that demonstrated 100%
protection against moderate and severe disease and 90.4% efficacy overall.
Clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K.
were also previously submitted to WHO, in which NVX-CoV2373 demonstrated
efficacy of 96.4% against the original virus strain, 86.3% against the Alpha
(B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373
demonstrated a favorable safety and tolerability profile.
Novavax recently announced authorization of its vaccine in Indonesia. The
company also announced regulatory filings for its vaccine in the United Kingdom
New Zealand (https://c212.net/c/link/?t=0&l=en&o=3348079-1&h=19248320&u=https%3A%2F%2Fir.novavax.com%2F2021-11-03-Novavax-Files-COVID-19-Vaccine-for-Provisional-Approval-in-New-Zealand&a=New+Zealand) and Canada, as well as the complete submission of all data and modules in theEuropean Union (https://c212.net/c/link/?t=0&l=en&o=3348079-1&h=3041693992&u=https%3A%2F%2Fir.novavax.com%2F2021-11-01-Novavax-Files-for-COVID-19-Vaccine-Authorization-with-Health-Canada-and-Completes-Submission-for-Rolling-Review-to-European-Medicines-Agency&a=European+Union) to support the final regulatory review of its dossier by the European Medicines Agency. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
The grant of WHO EUL is a prerequisite for exports to numerous countries
participating in the COVAX Facility, which was established to allocate and
distribute vaccines equitably to participating countries and economies. Novavax
continues to work closely with governments, regulatory authorities and
non-governmental organizations (NGOs) in its commitment to ensuring equitable
global access to its COVID-19 vaccine.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the
U.K. that demonstrated efficacy of 96.4% against the original virus strain,
86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the
PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection
against moderate and severe disease and 90.4% efficacy overall. It was
generally well-tolerated and elicited a robust antibody response.
NVX-CoV2373 is a protein-based vaccine candidate 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(TM) 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 microgram antigen and 50 microgram 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.
About Matrix-M(TM) Adjuvant
Novavax' patented saponin-based Matrix-M(TM) 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 combines the power and speed of
genetic engineering to efficiently produce highly immunogenic nanoparticles
designed to address urgent global health needs. Novavax is conducting
late-stage clinical trials for NVX-CoV2373, its vaccine candidate against
SARS-CoV-2, the virus that causes COVID-19. NanoFlu(TM), its quadrivalent
influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase
3 clinical trial in older adults. Both vaccine candidates incorporate Novavax'
proprietary saponin-based Matrix-M(TM) 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
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and
prospects, its partnerships, the ongoing development of NVX-CoV2373 and other
Novavax vaccine product candidates, the scope, timing and outcome of future
regulatory filings and actions and Novavax' plans to deliver a COVID-19 vaccine
to people around the globe 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 | +1 240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | +1 617-221-9197
aroy@soleburytrout.com
Media
Alison Chartan | +1 240-720-7804
Laura Keenan Lindsey | +1 202-709-7521
media@novavax.com
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SOURCE: Novavax, Inc.
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