- Modified agreement also includes the development of an
updated vaccine in fall 2023
GAITHERSBURG, Md., Feb. 13,
2023 /CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a
biotechnology company dedicated to developing and commercializing
next-generation vaccines for serious infectious diseases, today
announced a modification to its existing agreement with the U.S.
Department of Health and Human Services (HHS), in collaboration
with the Department of Defense, to deliver up to 1.5 million doses
of the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373). This
agreement will maintain the U.S. public's access to Novavax'
vaccine and support the development of smaller dose vials, strain
selection in line with U.S. Food and Drug Administration (FDA)
recommendations, and a smooth transition to the commercial
market.
"This agreement acknowledges the need to offer the American
people a diverse COVID-19 vaccine portfolio and underscores the
importance of Novavax' partnership with the U.S. government to
ensure continuous access to a protein-based option as part of
public health measures," said John C.
Jacobs, President and Chief Executive Officer,
Novavax. "We look forward to continuing our collaboration with
the U.S. government on the development of our COVID-19
vaccine to meet the requirements of the FDA and our commercial
customers for the upcoming 2023/2024 vaccination campaign."
This contract will support the U.S. government's continued
efforts to make Novavax' protein-based vaccine available for free
to states, jurisdictions, federal pharmacy partners and federally
qualified health centers.
The Novavax COVID-19 Vaccine, Adjuvanted received emergency use
authorization from the U.S. FDA for use to prevent COVID-19 in
adults aged 18 and older and in adolescents aged 12 through
17 as a primary series, and as a first booster dose at
least six months after completion of primary vaccination with an
authorized or approved COVID-19 vaccine to individuals aged 18 and
older for whom an FDA-authorized mRNA bivalent COVID-19 booster
vaccine is not accessible or clinically appropriate, and to
individuals aged 18 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.
This contract is supported with previously allocated federal
funds from HHS, the Administration for Strategic Preparedness and
Response, and Biomedical Advanced Research and Development
Authority, through the Department of Defense Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense under Contract Number W15QKN-16-9-1002, Project 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 U.S. 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 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.
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)
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
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 vaccine contains
purified protein antigen and can neither replicate, nor can it
cause COVID-19.
The vaccine is packaged as a ready-to-use liquid formulation and
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 its vaccine 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, 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
indications and populations 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, 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
formulation, the ongoing development of NVX-CoV2373, NVX-CoV2515
and a bivalent Omicron-based / original strain based vaccine, the
CIC vaccine candidate, a quadrivalent influenza investigational
vaccine candidate, the scope, timing and outcome of future
regulatory filings and actions, including 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, increasing
vaccination rates, controlling the pandemic, and protecting
populations, the efficacy, safety, intended utilization, and
expected administration of NVX-CoV2373 and the CIC vaccine
candidate 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; 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 and Giovanna Chandler | 202-709-5563
media@novavax.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/us-government-and-novavax-extend-partnership-securing-up-to-1-5-million-additional-doses-of-novavax-covid-19-vaccine-301744487.html
SOURCE Novavax, Inc.