- Novavax COVID-19 vaccine receives positive vote from U.S.
Food and Drug Administration Vaccines and Related Biological
Products Advisory Committee
- If Emergency Use Authorization is granted by the FDA, the
Novavax COVID-19 vaccine would become the first protein-based
COVID-19 vaccine available in the U.S.
GAITHERSBURG, Md., June 7, 2022 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced the U.S. Food and Drug Administration
(FDA) Vaccines and Related Biological Products Advisory Committee
(VRBPAC) voted 21 to 0, with one abstention, to recommend that the
FDA grant Emergency Use Authorization (EUA) for the Novavax
COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and
over.
"The advisory committee's positive recommendation acknowledges
the strength of our data and the importance of a protein-based
COVID-19 vaccine developed using an innovative approach to
traditional vaccine technology," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "In today's VRBPAC meeting, we heard the
overwhelming support for our vaccine from physicians, healthcare
organizations, and consumers who are eagerly anticipating a
protein-based vaccine option. Consistent with submissions to
regulatory authorities worldwide, we have already submitted an
amendment with updated manufacturing information for the EUA to the
FDA for review. We look forward to collaborating with the FDA as it
makes its final decision."
The VRBPAC considered data from the pivotal Phase 3 clinical
trial, PREVENT-19, which enrolled approximately 30,000 participants
aged 18 years and older in the U.S. and Mexico and was
published in the New England Journal of Medicine. In
the trial, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy
(95% confidence interval [CI], 82.9 to 94.6; P<0.001) with a
reassuring safety profile. Serious and severe adverse events were
low in number and balanced between vaccine and placebo groups. The
most common adverse reactions observed during the trial (frequency
category of very common ≥1/10) were headache, nausea or vomiting,
myalgia, arthralgia, injection site tenderness/pain, fatigue, and
malaise. The data showed that overall the rate of myocarditis
was balanced between the vaccine and placebo arms (0.007% and
0.005%) and in the post-crossover portions of Novavax trials the
observed cases were all within the expected rate.
The FDA considers the recommendations of VRBPAC when making
decisions on EUA.
The Novavax COVID-19 vaccine has received authorization for use
in individuals aged 18 and over from more than 40 countries in
addition to Emergency Use Listing from the World Health
Organization.
Authorization in the U.S.
The Novavax COVID-19 vaccine (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 spike (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 U.S. Department of Health and Human Services (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).
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 timing of
clinical trial results, the ongoing development of NVX-CoV2373,
including an Omicron strain based vaccine, a COVID-seasonal
influenza investigational vaccine candidate, the scope, timing and
outcome of future regulatory filings and actions, including the
FDA's upcoming decision regarding EUA for Novavax' COVID-19 vaccine
candidate, and Novavax' subsequent discussions with the CDC,
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, 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; unanticipated challenges or delays in conducting
clinical trials; 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 | 240-720-7804
media@novavax.com
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