U.S. Government Secures 3.2 Million Doses of Novavax COVID-19 Vaccine
PR96937
GAITHERSBURG, Md., July 11, 2022 /PRNewswire=KYODO JBN/ --
--Agreement will provide the first protein-based vaccine option in the U.S.,
pending FDA Emergency Use Authorization and CDC recommendation
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(TM)
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(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.
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 degrees - 8 degrees 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 greater than 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 percent. 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(TM) 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 ( https://www.linkedin.com/company/novavax/ ) .
*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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SOURCE Novavax, Inc.
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