- Novavax has developed a protein-based
monovalent XBB.1.5 COVID vaccine candidate
and is manufacturing at commercial scale with the intent to be in
market during the fall vaccination campaign
- Novavax shared data demonstrating that its XBB.1.5 COVID
vaccine candidate induces functional immune responses
to XBB subvariants including XBB.1.5, XBB.1.16 and XBB.2.3
- If authorized, Novavax's protein-based vaccine candidate
would be the only non-mRNA XBB.1.5 vaccine available in the
U.S.
- Novavax intends to supply vaccine globally, consistent with
FDA, WHO and EMA recommendations
GAITHERSBURG, Md., June 15,
2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
global company advancing protein-based vaccines with its novel
Matrix-M™ adjuvant, participated in today's U.S. Food and Drug
Administration (FDA) Vaccines and Related Biological Products
Advisory Committee's (VRBPAC) meeting, which resulted in a
unanimous vote recommending updating the current COVID vaccine
composition to a monovalent XBB-lineage.
"Novavax expects to be ready for the commercial delivery of a
protein-based monovalent XBB COVID vaccine this fall in line with
today's VRBPAC recommendation," said John C. Jacobs, President
and Chief Executive Officer, Novavax. "In partnership with
regulators and public health authorities, Novavax has been
developing and manufacturing this vaccine candidate, and now that
we are nearing harmonization on guidance from the FDA, the World
Health Organization and European Medicines Agency, we believe we
are in a better position to offer an alternative vaccine choice for
individuals worldwide."
Novavax presented data at the VRBPAC meeting that supports the
recommendation to vaccinate this fall with a monovalent XBB strain.
Novavax data showed that its XBB.1.5 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.
Novavax will seek updated FDA labeling for its XBB COVID vaccine
candidate with the goal of it being available and accessible on par
with other COVID vaccines.
Authorized 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.
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 operating plans and prospects, the
ongoing development of NVX-CoV2373, XBB variant vaccines
candidates, the scope, timing and outcome of future regulatory
filings and actions, the potential impact and reach of
Novavax and NVX-CoV2373 and its XBB variant candidates in
addressing vaccine access, protecting populations, the
efficacy, safety intended utilization, and the expected
administration of NVX-CoV2373 and XBB 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; 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'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
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