- Marketing Authorization replaces conditional Marketing
Authorization and is first for Novavax in the EU
- Marketing Authorization includes use of Nuvaxovid™ as a
primary series in individuals aged 12 and older and booster in
adults
- Marketing Authorization provides regulatory foundation for
future vaccine updates, including Fall vaccination
campaign
GAITHERSBURG, Md., July 6, 2023 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a global company advancing protein-based vaccines
with its novel Matrix-M™ adjuvant, has been granted full Marketing
Authorization (MA) by the European Commission in the European Union
(EU) for Nuvaxovid™ (NVX-CoV2373). This decision follows positive
opinion for a full MA from the Committee for Medicinal Products for
Human Use of the European Medicines Agency. The vaccine is now
fully authorized for use as a primary series in individuals aged 12
and older and as a booster dose in adults aged 18 and older for the
prevention of COVID-19. Nuvaxovid was originally granted a
conditional MA in the EU for these indications.
"This Marketing Authorization establishes the foundation for all
future regulatory approvals for updated versions of our COVID
vaccine, a necessity to ensure we can quickly get our vaccine to
individuals in the EU," said John C.
Jacobs, President and Chief Executive Officer, Novavax. "In
addition to the EU, we are preparing to file for full approval in
the U.S. as well as other markets and are committed to ensuring
protein-based options are available worldwide. Vaccine choice
remains an integral part of public health measures."
The Phase 3 PREVENT-19 trial demonstrated Nuvaxovid's reassuring
safety profile as well as efficacy as a primary series in adults,
the immunogenicity and safety as a booster dose in adults, and the
efficacy and safety as a primary series in individuals aged 12 and
older.
Novavax's COVID vaccine is authorized for use in more than 40
markets around the world.
Trade Name in the U.S.
The trade name Nuvaxovid™ has not yet been approved by the U.S.
Food and Drug Administration (FDA).
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 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, NVX-CoV2515 and bivalent
Omicron-based / original strain based vaccine, a COVID-19-Influenza
combination investigational vaccine candidate, a quadrivalent
influenza investigational vaccine candidate, the scope, timing and
outcome of future regulatory filings and actions, , 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
Logo -
https://mma.prnewswire.com/media/1506866/4151722/Novavax_High_Res_Logo.jpg
View original
content:https://www.prnewswire.co.uk/news-releases/novavaxs-nuvaxovid-receives-full-marketing-authorization-in-the-eu-for-the-prevention-of-covid-301871225.html