Novavax Announces Start of Rolling Review by Multiple Regulatory Authorities for COVID-19 Vaccine Authorization
February 04 2021 - 04:05PM
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing
next-generation vaccines for serious infectious diseases, today
announced the start of the rolling review process for authorization
of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory
agencies. The reviews will continue while the company completes its
pivotal Phase 3 trials in the United Kingdom (U.K.) and United
States (U.S.) and through initial authorization for emergency use
granted under country-specific regulations.
“The rolling review of our submission by
regulatory authorities of non-clinical data and early clinical
studies will help expedite the review process and bring us that
much closer to delivering a safe and effective vaccine worldwide,”
said Gregory M. Glenn, MD, President of Research and Development,
Novavax. “We appreciate the agencies’ confidence in Novavax based
on our early data and the collective sense of urgency to ensure
speedier access to much-needed COVID-19 vaccination.”
To date, Novavax has begun the rolling review
process with several regulatory agencies worldwide, including the
European Medicines Agency (EMA), U.S. Food and Drug Administration
(FDA), U.K. Medicines and Healthcare products Regulatory Agency
(MHRA), and Health Canada. As part of the rolling review, the
company will continue to submit additional information, including
clinical and manufacturing data.
Novavax’ recombinant protein-based vaccine
candidate is currently in Phase 3 clinical development in both the
U.K. and U.S. for the prevention of COVID-19. It was the first
vaccine to demonstrate clinical efficacy against the original
strain of COVID-19 and both of the rapidly emerging variants in the
United Kingdom and South Africa.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate
engineered from the genetic sequence 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 adjuvanted with
Novavax’ patented saponin-based Matrix-M™ 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. In preclinical studies,
NVX-CoV2373 induced antibodies that block binding of spike protein
to cellular receptors and provided protection from infection and
disease. It was generally well-tolerated and elicited robust
antibody response numerically superior to that seen in human
convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is
currently being evaluated in two pivotal Phase 3 trials: a trial in
the U.K that demonstrated 89.3 percent overall efficacy and 95.6
percent against the original strain in a post-hoc analysis, and the
PREVENT-19 trial in the U.S. and Mexico that began in December. It
is also being tested in two ongoing Phase 2 studies that began in
August: A Phase 2b trial in South Africa that demonstrated up to 60
percent efficacy against newly emerging escape variants, and a
Phase 1/2 continuation in the U.S. and Australia.
About Matrix-M™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 NovavaxNovavax,
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™, 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™
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 and LinkedIn.
Novavax Forward Looking Statements
Statements herein relating to the future
of Novavax and the ongoing development of its vaccine and
adjuvant products are forward-looking
statements. Novavax cautions that these forward-looking
statements are subject to numerous risks and uncertainties, which
could cause actual results to differ materially from those
expressed or implied by such statements. These risks and
uncertainties include those identified under the heading “Risk
Factors” in the Novavax Annual Report on Form 10-K for the year
ended December 31, 2019, and Quarterly Report on
Form 10-Q for the period ended September 30, 2020,
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 sec.gov, 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
Jennifer Porcelli | 617-974-8659
jporcelli@soleburytrout.com
Media
Amy Speak | 617-420-2461
Laura Keenan | 410-419-5755
media@novavax.com
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