Novavax Completes Enrollment of PREVENT-19, COVID-19 Vaccine Pivotal Phase 3 Trial in the United States and Mexico
February 22 2021 - 7:00AM
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing
next-generation vaccines for serious infectious diseases, today
announced the complete enrollment of PREVENT-19, its pivotal Phase
3 study in the United States and Mexico to evaluate the efficacy,
safety and immunogenicity of the company’s COVID-19 vaccine.
Novavax has previously reported positive interim efficacy results
of NVX-CoV2373, its recombinant protein-based vaccine candidate, in
an ongoing Phase 3 clinical trial taking place in the United
Kingdom.
“The full enrollment of PREVENT-19 is another
important step in building a body of evidence to demonstrate that
NVX-CoV2373 will be safe and effective across diverse,
representative populations,” said Gregory M. Glenn, President of
Research and Development, Novavax. “We thank the thousands of
volunteers and individuals, including our partners at NIH, the
COVID-19 Prevention Network and trial sites in the U.S. and Mexico,
who enabled rapid recruitment and enrollment in the trial, which we
believe is a critical aspect to building vaccine trust and uptake
across the globe.”
PREVENT-19 was planned with specific recruitment
diversity and representation goals and enrolled 30,000 volunteers.
Location of trial sites emphasized communities and demographic
groups most impacted by the disease, including those living with
co-morbid conditions that place them at higher risk of
complications from COVID-19. The trial largely reached its
demographic goals amid the concurrent rollout of vaccines
authorized for emergency use.
The trial enrolled diverse participants as
follows:
- LatinX: 20%
-
African American: 13%
-
Native American: 6%
-
Asian American: 5%
-
Older adults (65 years and older): 13%
PREVENT-19 is a randomized, placebo-controlled,
observer-blinded study to evaluate the efficacy, safety and
immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000
subjects 18 years of age and older compared with placebo. Two
thirds of the participants are assigned to randomly receive two
intramuscular injections of the vaccine, administered 21 days
apart, while one third of the trial participants receive placebo.
Trial sites were also selected in locations where transmission
rates were high to accelerate the accumulation of positive cases
that could show efficacy.
PREVENT-19 is being conducted with support from
the U.S. government partnership (formerly Operation Warp Speed),
which includes the Department of Defense, the Biomedical Advanced
Research and Development Authority (BARDA), part of the U.S.
Department of Health and Human Services (HHS) Office of the
Assistant Secretary for Preparedness and Response, and the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH) at HHS. BARDA is also providing
up to $1.75 billion under a Department of Defense agreement.
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 the 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 50-60
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
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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 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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