GAITHERSBURG, Md., May 26, 2023
/PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company
advancing protein-based vaccines with its novel Matrix-M™ adjuvant,
today announced that Nuvaxovid™ (NVX-CoV2373) has been recommended
for full Marketing Authorization (MA) for use as a primary series
in individuals aged 12 and older and as a booster in individuals
aged 18 and older for the prevention of COVID-19 in the European
Union (EU) following a positive opinion issued by the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency. The European Commission will review the CHMP recommendation
and is expected to make a final decision on the MA.
"The positive CHMP Opinion for full Marketing Authorization for
our COVID vaccine brings us one step closer to full authorization
and will provide an approval pathway for an updated vaccine in time
for the fall," said John C. Jacobs,
President and Chief Executive Officer, Novavax.
Novavax has demonstrated the efficacy and safety of Nuvaxovid as
a primary series, and the immunogenicity and safety of the vaccine
as a booster in individuals aged 12 and older in the Phase 3
PREVENT-19 trial, Phase 2 trials and in real-world evidence.
Novavax's COVID vaccine is authorized for use in more than 40
markets around the world. In the EU, Nuvaxovid has been
conditionally authorized as a two-dose primary series in
adults and adolescents, and as a booster dose in
adults.
Trade Name in the U.S.
The trade name Nuvaxovid™
has not yet been approved by the U.S. Food and Drug Administration
(FDA).
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 Nuvaxovid™ (NVX-CoV2373)
NVX-CoV2373 is a
protein-based vaccine made by creating copies of the surface spike
protein of SARS-CoV-2 that causes COVID. With Novavax's unique
recombinant nanoparticle technology, the non-infectious spike
protein serves as the antigen that primes the immune system to
recognize the virus, while Novavax's Matrix-M adjuvant enhances and
broadens the immune response. The vaccine is packaged as a
ready-to-use liquid formulation and is stored at 2° to 8°C,
enabling the use of existing vaccine supply and cold chain
channels.
About the PREVENT-19 Phase 3 Trial
The
PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19
(PREVENT-19) was a randomized, placebo-controlled, observer-blinded
Phase 3 trial conducted in the U.S. and Mexico to evaluate the efficacy and safety of
NVX-CoV2373 as a primary series and as a booster in adults and
adolescents to prevent SARS-CoV-2 infection. As a primary series,
the primary endpoint was the first occurrence of polymerase chain
reaction (PCR)-confirmed symptomatic (mild, moderate, or severe)
COVID-19 with onset at least seven days after the second dose in
29,960 adult participants aged 18 and older at baseline without
protocol violations prior to illness. A secondary endpoint was the
prevention of PCR-confirmed, symptomatic moderate or severe
COVID-19. Full results of the trial were published in the New
England Journal of Medicine.
The pediatric expansion of the trial evaluated 2,247 adolescents
aged 12 through 17 years in the U.S. Results from the
expansion were announced in February
2022. The adult booster expansion of the trial
evaluated a single booster dose of the vaccine in adult
participants approximately six months after their primary two-dose
vaccination series. Results from the expansion were announced in
October 2022.
About Matrix-M™ Adjuvant
When added to vaccines,
Novavax's patented saponin-based Matrix-M adjuvant enhances the
immune system response, making it stronger, broader, and more
durable. The Matrix-M adjuvant stimulates the entry of
antigen-presenting cells at the injection site and enhances antigen
presentation in local lymph nodes.
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, its
regulatory strategy and approval pathways in relation to
NVX-CoV2373 and its variant based COVID-19 vaccines, the scope,
timing and outcome of future regulatory filings and actions,
authorizations in Europe and
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, protecting populations, the efficacy,
safety intended utilization, and the 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; 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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SOURCE Novavax, Inc.