- Agreement will provide the first protein-based vaccine
option in the U.S., pending FDA Emergency Use Authorization and CDC
recommendation
GAITHERSBURG, Md., July 11, 2022 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced an agreement with the U.S. Department of
Health and Human Services (HHS), in collaboration with the
Department of Defense, to secure an initial 3.2 million doses of
Novavax' COVID-19 vaccine (NVX-CoV2373) should it receive U.S. Food
and Drug Administration (FDA) Emergency Use Authorization (EUA) and
a recommendation from the Centers for Disease Control and
Prevention (CDC). Novavax' protein-based vaccine will be made
available for free to states, jurisdictions, federal pharmacy
partners, and federally qualified health centers.
"We are pleased to come one step closer to potentially offering
our vaccine to physicians, healthcare organizations, and consumers
who have been awaiting a protein-based vaccine option," said
Stanley C. Erck, President and Chief
Executive Officer, Novavax. "We are grateful for the U.S.
government's ongoing support and partnership to bring Novavax'
COVID-19 vaccine to the U.S., and we look forward to the FDA's
decision on an emergency use authorization."
The Novavax COVID-19 vaccine 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. The Novavax COVID-19 vaccine contains purified
protein antigen and can neither replicate, nor can it cause
COVID-19.
On June 7, 2022, the FDA's
Vaccines and Related Biological Products Advisory Committee voted
to recommend that the FDA grant an EUA for the Novavax
COVID-19 vaccine for individuals aged 18 and over. The FDA is
currently reviewing Novavax' application for EUA. If EUA is
granted, a potential policy recommendation from the CDC would be
the final step before immunizations with the Novavax COVID-19
vaccine could begin.
Authorization in the U.S.
NVX-CoV2373 has not yet been
authorized for use in the U.S.
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. The vaccine was
created using Novavax' recombinant nanoparticle technology to
generate antigen derived from the coronavirus 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.
The 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, 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 the NVX-CoV2373 Phase 3 Trials
NVX-CoV2373
continues being evaluated in two pivotal Phase 3 trials.
PREVENT-19 (the PRE-fusion protein
subunit Vaccine Efficacy Novavax Trial
| COVID-19) is a 2:1 randomized, placebo-controlled,
observer-blinded trial to evaluate the efficacy, safety, and
immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 29,960
participants 18 years of age and over in 119 locations in the
U.S. and Mexico. The primary endpoint for PREVENT-19 was the first
occurrence of PCR-confirmed symptomatic (mild, moderate, or severe)
COVID-19 with onset at least seven days after the second dose in
serologically negative (to SARS-CoV-2) adult participants at
baseline. The statistical success criterion included a lower bound
of 95% CI >30%. A secondary endpoint was the prevention of
PCR-confirmed, symptomatic moderate or severe COVID-19. Both
endpoints were assessed at least seven days after the second study
vaccination in volunteers who had not been previously infected with
SARS-CoV-2. In the trial, NVX-CoV2373 achieved 90.4% efficacy
overall. It was generally well-tolerated and elicited a robust
antibody response after the second dose in both studies. Full
results of the trial were published in the New England Journal
of Medicine (NEJM).
The pediatric expansion of PREVENT-19 is a 2:1 randomized,
placebo-controlled, observer-blinded trial to evaluate the safety,
effectiveness, and efficacy of NVX-CoV2373 with Matrix-M adjuvant
in 2,247 adolescent participants 12 to 17 years of age in 73
locations in the United States,
compared with placebo. In the pediatric trial, NVX-CoV2373 achieved
its primary effectiveness endpoint (non-inferiority of the
neutralizing antibody response compared to young adult participants
18 through 25 years of age from PREVENT-19) and demonstrated 80%
efficacy overall at a time when the Delta variant of concern was
the predominant circulating strain in the U.S. Additionally, immune
responses were about two-to-three-fold higher in adolescents than
in adults against all variants studied.
PREVENT-19 is being conducted with support from the U.S.
government, including the Department of Defense, the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response at
the HHS, and the National Institute of Allergy and Infectious
Diseases, part of the National Institutes of Health at HHS. BARDA
is providing up to $1.75 billion under a Department of Defense
agreement (# MCDC2011-001). The Department of Defense Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense is also providing funding of up to $45.7 million under a separate agreement. To
date, the U.S. government has agreed to order 3.2 million doses of
NVX-CoV2373 under these existing agreements should NVX-CoV2373
receive FDA EUA and a recommendation from the CDC. Novavax and the
U.S. government will determine the timing, pricing, and amounts for
delivery of any additional NVX-CoV2373 doses upon FDA EUA. Novavax
intends to pursue additional U.S. procurement of both NVX-CoV2373
doses and other potential formulations.
Additionally, a trial conducted in the U.K. with 14,039
participants aged 18 years and over was designed as a randomized,
placebo-controlled, observer-blinded study and achieved overall
efficacy of 89.7%. The primary endpoint was based on the first
occurrence of PCR-confirmed symptomatic (mild, moderate or severe)
COVID-19 with onset at least seven days after the second study
vaccination in serologically negative (to SARS-CoV-2) adult
participants at baseline. Full results of the trial were published
in NEJM.
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 currently under review by
multiple regulatory agencies worldwide and will soon be under
review in the U.S. for use in adults, adolescents and as a booster.
In addition to its COVID-19 vaccine, Novavax is also currently
evaluating a COVID-seasonal influenza combination vaccine candidate
in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and
NanoFlu*, its quadrivalent influenza investigational vaccine
candidate, and is also evaluating an Omicron strain-based vaccine
(NVX-CoV2515) as well as a bivalent Omicron-based / original
strain-based vaccine. 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.
*NanoFlu identifies a recombinant hemagglutinin (HA) protein
nanoparticle influenza vaccine candidate produced by Novavax. This
investigational candidate was evaluated during a controlled phase 3
trial conducted during the 2019-2020 influenza season.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, its
partnerships, the potential for subsequent orders from the U.S.
government for additional doses of NVX-CoV2373 and other potential
formulations, the timing of clinical trial results, the ongoing
development of NVX-CoV2373, a COVID-seasonal influenza
investigational vaccine candidate, the scope, timing and outcome of
future regulatory filings and actions, including with respect to an
FDA EUA decision and potential CDC recommendation for NVX-CoV2373,
Novavax' plans to supplement existing authorizations with data from
the additional manufacturing sites in Novavax' global supply chain,
additional worldwide authorizations of NVX-CoV2373 for use in
adults and adolescents and as a booster, the potential impact
and reach 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 and
expected administration 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, without
limitation, 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, 2021 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
Alex Delacroix | 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
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