- If authorized, Novavax' vaccine would be the first
protein-based COVID-19 booster for adults
- If authorized, the Novavax COVID-19 Vaccine, Adjuvanted
could be used as a booster dose for adults aged 18 and older
vaccinated with any other currently available COVID-19
vaccine
GAITHERSBURG, Md., Aug. 15, 2022 /PRNewswire/ -- Novavax,
Inc. (Nasdaq: NVAX), a biotechnology company dedicated to
developing and commercializing next-generation vaccines for serious
infectious diseases, today announced that it submitted an
application to the U.S. Food and Drug Administration (FDA) for
Emergency Use Authorization (EUA) of its protein-based COVID-19
Vaccine, Adjuvanted for active immunization to prevent coronavirus
disease 2019 (COVID-19) caused by the severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2) as a homologous and
heterologous booster in adults aged 18 and older.
"It's important for people to have a choice as they evaluate how
to stay protected against COVID-19, and boosters are an invaluable
tool to build upon immunity obtained from previous vaccinations,"
said Stanley C. Erck, President and
Chief Executive Officer, Novavax. "Based on the data presented to
the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a
broad, long-lasting immune response against a range of
variants."
This application for EUA is supported by data from
Novavax' Phase 3 PREVENT-19 trial conducted in
the United States and Mexico, and from the UK-sponsored COV-BOOST
Phase 2 trial. As part of an open-label booster phase of the
PREVENT-19 trial, a single booster dose of the Novavax COVID-19
Vaccine, Adjuvanted was administered to healthy adult participants
at least six months after their primary two-dose vaccination series
of the Novavax COVID-19 Vaccine, Adjuvanted. The third dose
produced robust antibody responses comparable to or exceeding
levels associated with the efficacy data in the primary series
Phase 3 clinical trials. In the COV-BOOST trial, the Novavax
COVID-19 Vaccine, Adjuvanted induced a significant antibody
response when used as a heterologous third booster dose.
In the PREVENT-19 trial, following the booster, local and
systemic reactions had a median duration of approximately two days.
Safety reporting of reactogenicity events showed an increasing
incidence across all three doses of the Novavax COVID-19 Vaccine,
Adjuvanted, reflecting the increased immunogenicity seen with a
third dose. Medically attended adverse events, potentially
immune-mediated medical conditions, and severe adverse events
occurred infrequently following the booster dose.
In the U.S., the FDA granted EUA, followed by a positive
recommendation from the U.S. Centers for Disease Control and
Prevention's (CDC) Advisory Committee on Immunization Practices
(ACIP), and endorsement from the CDC for a two-dose primary series
in adults aged 18 and older in July. Doses of the Novavax
COVID-19 Vaccine, Adjuvanted have been available for use in the
U.S. since July.
This project has been supported in part with federal funds from
the Department of Health and Human Services (HHS); the
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA), through the
Department of Defense Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense (JPEO-CBRND) under
contract number MCDC2011-001.
Use of the Novavax COVID-19 Vaccine, Adjuvanted in the
U.S.
The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or
licensed by the US Food and Drug Administration (FDA), but has been
authorized for emergency use by FDA, under an Emergency Use
Authorization (EUA) to provide a two-dose primary series to
individuals 18 years of age and older to prevent Coronavirus
Disease 2019 (COVID-19).
The emergency use of this product is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of emergency use of the medical product under Section
564(b)(1) of the FD&C Act unless the declaration is terminated
or authorization revoked sooner.
Authorized Use
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use
under an Emergency Use Authorization (EUA) to provide a two-dose
primary series for active immunization to prevent coronavirus
disease 2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and
older.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to
individuals with a known history of a severe allergic reaction
(e.g., anaphylaxis) to any component of the Novavax COVID-19
Vaccine, Adjuvanted.
Warnings and Precautions
Management of Acute Allergic Reactions: Appropriate
medical treatment to manage immediate allergic reactions must be
immediately available in the event an acute anaphylactic reaction
occurs following administration of the Novavax COVID-19 Vaccine,
Adjuvanted. Monitor the Novavax COVID-19 Vaccine, Adjuvanted
recipients for the occurrence of immediate adverse reactions
according to the Centers for Disease Control (CDC) and
Prevention guidelines.
Myocarditis and Pericarditis: Clinical trials data
provide evidence for increased risks of myocarditis and
pericarditis following administration of the Novavax COVID-19
Vaccine, Adjuvanted (see Full EUA Prescribing
Information).
Syncope (fainting): May occur in association with
administration of injectable vaccines. Procedures should be in
place to avoid injury from fainting.
Altered Immunocompetence: Immunocompromised persons,
including individuals receiving immunosuppressant therapy, may have
a diminished immune response to the Novavax COVID-19 Vaccine,
Adjuvanted.
Limitations of Vaccine Effectiveness: The Novavax
COVID-19 Vaccine, Adjuvanted may not protect all vaccine
recipients.
Adverse Reactions
Adverse reactions reported in clinical trials following
administration of the Novavax COVID-19 Vaccine, Adjuvanted include
injection site pain/tenderness, fatigue/malaise, muscle pain,
headache, joint pain, nausea/vomiting, injection site redness,
injection site swelling, fever, chills, injection site pruritus,
hypersensitivity reactions, lymphadenopathy-related reactions,
myocarditis, and pericarditis.
Myocarditis, pericarditis, and anaphylaxis have been reported
following administration of the Novavax COVID-19 Vaccine,
Adjuvanted outside of clinical trials.
Additional adverse reactions, some of which may be serious, may
become apparent with more widespread use of the Novavax COVID-19
Vaccine, Adjuvanted.
Reporting Adverse Events and Vaccine Administration
Errors
The vaccination provider enrolled in the federal COVID-19
Vaccination Program is responsible for mandatory reporting of the
following to the Vaccine Adverse Event Reporting System
(VAERS):
- vaccine administration errors whether or not associated with an
adverse event,
- serious adverse events (irrespective of attribution to
vaccination),
- cases of Multisystem Inflammatory Syndrome (MIS), and
- cases of COVID-19 that results in hospitalization or
death.
Complete and submit reports to VAERS online:
https://vaers.hhs.gov/reportevent.html. For further assistance with
reporting to VAERS, call 1-800-822-7967. The reports should include
the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the
description section of the report.
To the extent feasible, report adverse events to Novavax, Inc.
using the following contact information or by providing a copy of
the VAERS form to Novavax, Inc.
Website: www.NovavaxMedInfo.com, Fax Number:
1-888-988-8809, Telephone Number: 1-844-NOVAVAX
(1-844-668-2829).
Please click to see the Novavax COVID-19 Vaccine,
Adjuvanted Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccine Providers) and EUA Full Prescribing
Information.
About the Novavax COVID-19 Vaccine, Adjuvanted
(NVX-CoV2373)
The Novavax COVID-19 Vaccine,
Adjuvanted 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. The Novavax COVID-19 Vaccine, Adjuvanted contains
purified protein antigen and can neither replicate, nor can it
cause COVID-19.
The Novavax COVID-19 Vaccine, Adjuvanted 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.
The PREVENT-19 trial is being conducted with support from the
U.S. government, including the Department of Defense, 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 (number MCDC2011-001). JPEO-CBRND 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 the Novavax COVID-19 Vaccine, Adjuvanted. Novavax
and the U.S. government will determine the timing, pricing, and
amounts for delivery of any additional doses. Novavax intends to
pursue additional U.S. procurement of both the Novavax COVID-19
Vaccine, Adjuvanted doses and other potential
formulations.
Novavax has established partnerships for the manufacture,
commercialization, and distribution of the Novavax COVID-19
Vaccine, Adjuvanted 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 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. The
Novavax COVID-19 Vaccine, Adjuvanted, the company's COVID-19
vaccine, has received authorization from multiple regulatory
authorities globally, including in the U.S., European Union and
with the World Health Organization. The vaccine is currently under
review by multiple regulatory agencies worldwide, including for
additional indications and populations such as 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 the Novavax
COVID-19 Vaccine, Adjuvanted and NanoFlu*, its quadrivalent
influenza investigational vaccine candidate, and is also evaluating
an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent
format 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, NVX-CoV2515, a
bivalent vaccine candidate and a COVID-seasonal influenza
investigational combination vaccine candidate, the scope, timing
and outcome of future regulatory filings and actions, including
potential recommendations and authorizations from 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 evolving
COVID-19 pandemic, the potential impact and reach of Novavax and
NVX-CoV2373 in addressing vaccine access, controlling the pandemic
and protecting populations, the efficacy, safety, intended
utilization, and expected administration of NVX-CoV2373 and
Novavax' other vaccine candidates 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 Erika Schultz |
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.