- Novavax's 2023-2024 season COVID vaccine candidate induced
neutralizing responses to emerging subvariants EG.5.1 and
XBB.1.16.6 in addition to XBB.1.5, XBB.1.16 and
XBB.2.3
- Upon regulatory approval, Novavax's COVID vaccine would be
the only protein-based non-mRNA vaccine option available in key
markets for the fall season
GAITHERSBURG, Md., Aug. 22, 2023 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a global company advancing protein-based vaccines
with its novel Matrix-M™ adjuvant, today announced that its
updated protein-based XBB COVID vaccine candidate induced
neutralizing antibody responses to the EG.5.1 and XBB.1.16.6
subvariants in small animal and non-human primate studies. XBB
sublineage variants are overwhelmingly responsible for the majority
of current COVID cases in the U.S. and European Union.1,
2
"Our data have shown that Novavax's protein-based COVID vaccine
induces broadly neutralizing responses against XBB subvariants,
including EG.5.1 and XBB.1.16.6," said Filip Dubovsky, President of Research and
Development, Novavax. "We have a lot of confidence in our updated
COVID vaccine and are working diligently with global regulatory
bodies to ensure our protein-based vaccine is available this
fall."
Non-clinical data previously showed that Novavax's COVID vaccine
candidate induced functional immune responses for XBB.1.5, XBB.1.16
and XBB.2.3 variants, indicating a broad response that could
potentially be applicable for forward-drift variants.3
Novavax is in the process of submitting applications for its
XBB.1.5 COVID vaccine candidate to regulatory authorities
globally.
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 Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes
improved health by discovering, developing and commercializing
innovative vaccines to protect against serious infectious diseases.
Novavax, a global company based in Gaithersburg, Md., U.S., offers a
differentiated vaccine platform that combines a recombinant protein
approach, innovative nanoparticle technology and Novavax's patented
Matrix-M adjuvant to enhance the immune response. Focused on the
world's most urgent health challenges, Novavax is currently
evaluating vaccines for COVID, influenza, and COVID and influenza
combined. Please visit novavax.com and LinkedIn for more
information.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its near term priorities including
delivering an updated, COVID vaccine for the 2023 fall vaccination
season, the scope, timing and outcome of future and pending
regulatory filings and actions, including submissions of
applications to global regulatory authorities , 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, assay validation, and stability testing,
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; challenges or
delays in conducting clinical trials or obtaining regulatory
authorization for our product candidates, including for our
monovalent XBB COVID vaccine in time for the fall 2023 vaccination
season, or for future COVID variant strain changes; challenges
meeting contractual requirements under agreements with multiple
commercial, governmental, and other entities; manufacturing,
distribution, or export delays or challenges, including the
requirement to obtain approval from the drug licensing body in
India for the distribution of
Novavax's updated XBB COVID vaccine; Novavax's exclusive dependence
on Serum for co-formulation and filling, and PCI for finishing
NVX-CoV2373 and the impact of any delays or disruptions in these
suppliers' operations on the delivery of customer orders;
challenges in implementing our global restructuring and cost
reduction plan; 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's Annual Report on Form 10-K for the year ended
December 31, 2022 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
240-720-7804
media@novavax.com
References
- Centers for Disease Control and Prevention (CDC).
(2023). Variant Proportions [Data set]. In COVID Data
Tracker.
https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
- European Centers for Disease Control and Prevention.
(2023). Country overview report: week 32 2023 [Virus
variants].
https://www.ecdc.europa.eu/en/covid-19/country-overviews.
- Markov PV, Ghafari M, Beer M, et al. The evolution of
SARS-CoV-2. Nat Rev Microbiol. 2023;21(6):361-379.
doi:10.1038/s41579-023-00878-2.
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