GAITHERSBURG, Md., Oct. 19, 2022 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced that the Novavax COVID-19 Vaccine,
Adjuvanted (NVX-CoV2373) has received emergency use
authorization (EUA) from the U.S. Food and Drug Administration
(FDA) to provide a first booster dose at least six months after
completion of primary vaccination with an authorized or approved
COVID-19 vaccine to individuals 18 years of age and older for whom
an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not
accessible or clinically appropriate, and to individuals 18 years
of age and older who elect to receive the Novavax COVID-19 Vaccine,
Adjuvanted because they would otherwise not receive a booster dose
of a COVID-19 vaccine.
"The U.S. now has access to the Novavax COVID-19 Vaccine,
Adjuvanted, the first protein-based option, as a booster," said
Stanley C. Erck, President and Chief
Executive Officer, Novavax. "According to CDC data, almost 50
percent of adults who received their primary series have yet to
receive their first booster dose. Offering another vaccine choice
may help increase COVID-19 booster vaccination rates for these
adults."
The FDA EUA decision was based on data from the Phase 3
Prevent-19 clinical trial and from the U.K.-sponsored COV-BOOST
trial. In the Phase 3 trial, a single booster dose of the Novavax
COVID-19 Vaccine, Adjuvanted was administered to healthy adult
participants aged 18 and older approximately eight or 11 months
after their primary series. Following a booster dose, antibody
levels increased significantly relative to pre-boost levels, rising
above levels associated with protection in the Phase 3 trials.
Neutralizing antibodies also increased by 34- to 27-fold compared
to pre-boost levels when boosted at eight or 11 months. In the
COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted increased
antibody titers when used as a third dose following initial dosing
with another authorized COVID-19 vaccine (heterologous
boosting).
In the trial, following the booster, local and systemic
reactions had a median duration of approximately two days. The
incidence of Grade 3 or higher events remained relatively low.
Safety reporting of reactogenicity events showed an increasing
incidence across all three doses of the Novavax COVID-19 Vaccine,
Adjuvanted, often seen with increased immunogenicity. Among
participants 18 years of age and older, solicited adverse reactions
following administration of a booster dose of the Novavax COVID-19
Vaccine, Adjuvanted were injection site pain/tenderness (81.1%),
fatigue/malaise (63.4%), muscle pain (63.0%), headache (52.9%),
joint pain (30.3%), nausea/vomiting (14.7%), injection site
swelling (8.4%), injection site redness (6.3%), and fever
(6.3%).
The next step for the vaccine is a policy recommendation for use
as a first booster from the Centers for Disease Control and
Prevention (CDC). Doses of the Novavax COVID-19 Vaccine,
Adjuvanted are available for use in the U.S. pending this final
step and can be located on Vaccines.gov.
Novavax' vaccine is also available for use as a booster in
adults aged 18 and older in the European Union, Japan, Australia, New
Zealand, Switzerland, and
Israel. In addition, a number of
countries have policy recommendations allowing use of the vaccine
as a heterologous or homologous booster dose. In the U.S., the FDA
granted EUA for a two-dose primary series in adults aged 18 and
older in July and for adolescents aged 12 through 17 in
August. Following these EUA's, the CDC recommended the vaccine for
use as a primary series for both age groups.
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 vaccine 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 prevent
Coronavirus Disease 2019 (COVID-19) as a primary series individuals
12 years of age and older. The Novavax COVID-19 Vaccine, Adjuvanted
vaccine is also authorized to provide a first booster dose at least
6 months after completion of primary vaccination with an authorized
or approved COVID-19 vaccine to individuals 18 years of age and
older for whom an FDA-authorized mRNA bivalent COVID-19 booster
vaccine is not accessible or clinically appropriate, and to
individuals 18 years of age and older who elect to receive the
Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise
not receive a booster dose of a COVID-19 vaccine.
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 12 years of age and older. The Novavax COVID-19
Vaccine, Adjuvanted vaccine is also authorized to provide a first
booster dose at least 6 months after completion of primary
vaccination with an authorized or approved COVID-19 vaccine to
individuals 18 years of age and older for whom an FDA-authorized
mRNA bivalent COVID-19 booster vaccine is not accessible or
clinically appropriate, and to individuals 18 years of age and
older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted
because they would otherwise not receive a booster dose of a
COVID-19 vaccine.
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). The CDC
has published considerations related to myocarditis and
pericarditis after vaccination, including for vaccination of
individuals with a history of myocarditis or pericarditis
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html#myocarditis-pericarditis).
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, anaphylaxis, paresthesia, and
hypoesthesia 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 myocarditis,
- cases of pericarditis,
- cases of Multisystem Inflammatory Syndrome (MIS), in adults and
children, and
- cases of COVID-19 that results in hospitalization or
death.
Complete and submit reports to VAERS online: 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 (Vaccination Providers) and EUA Full Prescribing
Information.
Please click to see the Fact Sheet for Recipients and
Caregivers.
About NVX-CoV2373 (Novavax' COVID-19 Vaccine,
Adjuvanted)
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.
NVX-CoV2373 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 of NVX-CoV2373 is being conducted with
support from the U.S. government, including the Department of
Defense, BARDA, part of the Administration for Strategic
Preparedness and Response, 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 NVX-CoV2373
under these existing agreements. Novavax and the U.S. government
will determine the timing, pricing, and amounts for delivery of any
additional NVX-CoV2373 doses. Novavax intends to pursue additional
U.S. procurement of both NVX-CoV2373 doses and other potential
formulations.
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 are being
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 has received
authorization from multiple regulatory authorities globally,
including the U.S. FDA, the European Commission, and the World
Health Organization. The vaccine is currently under review by
multiple regulatory agencies worldwide, including for additional
populations and indications such as adolescents and as a booster.
In addition to its COVID-19 vaccine, Novavax is also currently
evaluating its COVID-19-Influenza Combination (CIC) vaccine
candidate in a Phase 1/2 clinical trial, its quadrivalent influenza
investigational vaccine candidate, and 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.
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 and bivalent
Omicron-based / original strain based vaccine, a CIC
investigational 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 and intended utilization, 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; unanticipated challenges or delays in
conducting clinical trials; 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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