Novavax and Serum Institute of India Announce Submission to World Health Organization for Emergency Use Listing of Novavax' COVID-19 Vaccine
PR91879
GAITHERSBURG, Md., Sept. 24, 2021 /PRNewswire=KYODO JBN/ --
-- Novavax and Serum Institute of India file regulatory submission for
World Health Organization Emergency Use Listing of Novavax' recombinant
nanoparticle protein-based COVID-19 vaccine
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
with its partner, Serum Institute of India Pvt. Ltd. (SII), today announced a
regulatory submission to the World Health Organization (WHO) for emergency use
listing (EUL) of Novavax' recombinant nanoparticle protein-based COVID-19
vaccine candidate with Matrix-M(TM) adjuvant. The submission to WHO is based on
the companies' previous regulatory submission to the Drugs Controller General
of India (DCGI).
"Today's submission of our protein-based COVID-19 vaccine to WHO for emergency
use listing is a significant step on the path to accelerating access and more
equitable distribution to countries in great need around the world," said
Stanley C. Erck, President and Chief Executive Officer, Novavax. "It represents
another major milestone in Novavax' transformation into a commercial global
vaccine company and reinforces the value of global collaboration and need for
multiple approaches to help control the pandemic."
The grant of EUL by the WHO 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. In
addition to the submission for WHO EUL, SII and Novavax last month completed
the submission of modules required by regulatory agencies in India, Indonesia
and the Philippines for the initiation of review of the vaccine, including
preclinical, clinical, and chemistry, manufacturing and controls (CMC) data.
About NVX-CoV2373
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 degrees- 8 degrees 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 and will be advanced for regulatory
submission. 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 Twitter
(https://c212.net/c/link/?t=0&l=en&o=3300920-1&h=1196317460&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3158017-1%26h%3D500821283%26u%3Dhttps%253A%252F%252Ftwitter.com%252FNovavax%26a%3DTwitter&a=Twitter) and LinkedIn (https://c212.net/c/link/?t=0&l=en&o=3300920-1&h=1356596439&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3158017-1%26h%3D3702938248%26u%3Dhttps%253A%252F%252Fwww.linkedin.com%252Fcompany%252Fnovavax%252F%26a%3DLinkedIn&a=LinkedIn).
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and
prospects, the ongoing development of NVX-CoV2373 and other Novavax vaccine
product candidates, timing of future regulatory filings and actions, and the
role that Novavax may play in helping control the COVID-19 pandemic 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
Alison Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
media@novavax.com
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SOURCE Novavax
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