Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA
10 November 2020 - 12:30AM
Novavax, Inc. (Nasdaq: NVAX), a late-stage biotechnology
company developing next-generation vaccines for serious infectious
diseases, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track Designation for
NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Currently in
late-phase clinical development, NVXCoV2373 is a stable, prefusion
protein made using Novavax’ nanoparticle technology and includes
its proprietary MatrixM™ adjuvant.
“The FDA’s decision to grant Fast Track
Designation for NVX-CoV2373 reflects the urgent need for a safe and
effective vaccine to prevent COVID-19, and we look forward to
working closely with the agency to accelerate access to this
vaccine,” said Gregory M. Glenn, M.D., President of Research and
Development, Novavax. “While the regulatory review of this clinical
program will be expedited, Novavax remains committed to a
data-driven and scientifically rigorous approach in demonstrating
safety and efficacy, which we believe will support confidence in
the vaccine in the U.S. and globally.”
Novavax expects to begin its pivotal Phase
3 clinical trial in the United States and Mexico by
the end of November. Data from the event-driven trial could support
global authorization and approval, including in the U.S. The
Company’s ongoing Phase 3 clinical trial in the UK to evaluate the
efficacy, safety and immunogenicity of NVX-CoV2373 is expected
to be fully enrolled by the end of November. Depending on the
overall COVID-19 attack rate, interim data in the UK trial, which
is also event-driven, are expected as soon as early first quarter
2021.
About NVX-CoV2373
NVX-CoV2373 is a 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 contains 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 cannot replicate,
nor can it cause COVID-19. In preclinical trials, NVX-CoV2373
demonstrated induction of antibodies that block binding of spike
protein to receptors targeted by the virus, a critical aspect for
effective vaccine protection. In the Phase 1 portion of its Phase
1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and
elicited robust antibody responses numerically superior to that
seen in human convalescent sera. NVX-CoV2373 is also being
evaluated in a Phase 3 trial in the UK and two ongoing
Phase 2 studies that began in August; a Phase 2b trial
in South Africa, and a Phase 1/2 continuation in
the U.S. and Australia. Novavax has
secured $2 billion in funding for its global coronavirus
vaccine program, including up to $399 million in funding
from the Coalition for Epidemic Preparedness
Innovations (CEPI) and almost $1.7 billion from the U.S.
government.
About Fast Track Designation
Fast Track Designation by the U.S. FDA is a
process designed to facilitate the development and expedite the
review of drugs to treat serious conditions and fill an unmet
medical need, with the intent of getting important new drugs to the
patient earlier. Fast Track addresses a broad range of serious
conditions. Specifically, Fast Track Designation facilitates
meetings with FDA to discuss all aspects of development to support
licensure and provides the opportunity to submit sections of a BLA
on a rolling basis as data become available.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a late-stage
biotechnology company that promotes improved health globally
through the discovery, development, and commercialization of
innovative vaccines to prevent serious infectious
diseases. Novavax is undertaking 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. Both vaccine candidates incorporate Novavax’
proprietary saponin-based Matrix-M™ adjuvant to enhance the immune
response and stimulate high levels of neutralizing
antibodies. Novavax is a leading innovator of recombinant vaccines;
its proprietary recombinant technology platform combines the power
and speed of genetic engineering to efficiently produce highly
immunogenic nanoparticles in order to address urgent global health
needs.
For more information,
visit www.novavax.com and connect with us
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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 June 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
Erika Trahan ir@novavax.com
240-268-2022
Media
Brandzone/KOGS Communication
Edna Kaplan kaplan@kogspr.com
617-974-8659
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