- Novavax's updated COVID-19 vaccine is the only updated
protein-based non-mRNA COVID-19 vaccine available in the European
Union for individuals aged 12 and older
- Novavax is working closely with EU member states to bring
its updated COVID-19 vaccine to those that have requested doses
through the advance purchase agreement
GAITHERSBURG, Md., Oct. 31,
2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
global company advancing protein-based vaccines with its
Matrix-M™ adjuvant, today announced the European
Commission has granted approval for Nuvaxovid™ XBB.1.5
dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted)
(NVX-CoV2601) for active immunization to prevent COVID-19 caused by
SARS-CoV-2 in individuals aged 12 and older. This decision
follows positive opinion for approval from the Committee for
Medicinal Products for Human Use of the European Medicines
Agency.
"Today's approval of the only updated protein-based non-mRNA
COVID-19 vaccine in the EU is an important milestone as the need
for vaccination continues," said John C.
Jacobs, President and Chief Executive Officer, Novavax.
"Novavax is working closely with national authorities to have our
updated vaccine delivered and available in Europe in the coming weeks."
Novavax is working closely with EU member states that have
requested doses through the advance purchase agreement to confirm
timing of dose delivery on a country-by-country basis.
Approval was based on non-clinical data showing that
Novavax's updated COVID-19 vaccine induced functional immune
responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants.
Additional non-clinical data demonstrated that Novavax's vaccine
induced neutralizing antibody responses to newly emerging
subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as CD4+
polyfunctional cellular (T-cell) responses against EG.5.1 and
XBB.1.16.6. These data indicate Novavax's vaccine can stimulate
both arms of the immune system and may induce a broad response
against circulating variants.1,2
In clinical trials, the most common adverse reactions associated
with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included
headache, nausea or vomiting, muscle pain, joint pain, injection
site tenderness, injection site pain, fatigue and malaise.
Novavax's vaccine is authorized for use in the U.S. and is
currently under review in other markets.
NOVAVAX COVID-19 VACCINE, ADJUVANTED (2023-2024 FORMULA)
AUTHORIZED USES
Novavax COVID-19 Vaccine, Adjuvanted
(2023-2024 Formula) has not been approved or licensed by FDA, but
has been authorized for emergency use by FDA, under an EUA to
prevent Coronavirus Disease 2019 (COVID-19) for use in individuals
12 years of age and older. Refer to the full Fact Sheet for
information about the Novavax COVID-19 Vaccine, Adjuvanted.
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
What should you mention to your vaccination provider before you
or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
Tell your vaccination provider about all of your or your child's
medical conditions, including if you or your child:
- have any allergies
- have had myocarditis (inflammation of the heart muscle) or
pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects your
immune system
- are pregnant or plan to become pregnant
- are breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
Who should not get the Novavax COVID-19 Vaccine,
Adjuvanted?
A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if
they had:
- a severe allergic reaction after a previous dose of any Novavax
COVID-19 Vaccine, Adjuvanted
- a severe allergic reaction to any ingredient of these
vaccines
What are the risks of the Novavax COVID-19 Vaccine,
Adjuvanted?
There is a remote chance that the vaccine could cause a severe
allergic reaction. A severe allergic reaction would usually occur
within a few minutes to one hour after getting a dose. For this
reason, the vaccination provider may ask you or your child to stay
at the place where you or your child received the vaccine for
monitoring after vaccination. Signs of a severe allergic reaction
can include:
- Difficulty breathing
- Swelling of the face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis
(inflammation of the lining outside the heart) have occurred in
some people who have received the vaccine. In most of these people,
symptoms began within 10 days following vaccination. The chance of
having this occur is very low. You should seek medical attention
right away if you or your child have any of the following symptoms
after receiving the vaccine:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding
heart
Side effects that have been reported in clinical trials with the
Novavax COVID-19 Vaccine, Adjuvanted include:
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the
heart)
- Injection site reactions: pain/tenderness, swelling, redness
and itching
- General side effects: fatigue or generally feeling unwell,
muscle pain, headache, joint pain, nausea, vomiting, fever,
chills
- Allergic reactions such as hives and swelling of the face
- Swollen lymph nodes
Side effects that have been reported in post-authorization use
with the Novavax COVID-19 Vaccine, Adjuvanted include:
- Severe allergic reactions
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the
heart)
- Paresthesia (unusual feeling in the skin such as tingling or a
crawling feeling)
- Hypoesthesia (decreased feeling or sensitivity, especially in
the skin)
These may not be all the possible side effects. Serious and
unexpected side effects may occur. The possible side effects are
still being studied.
What should I do about side effects?
If you or your child experience a severe allergic reaction, call
9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider for
any side effects that bother you or your child or do not go
away.
Report vaccine side effects to the FDA and the Centers for
Disease Control and Prevention (CDC) Vaccine Adverse Event
Reporting System (VAERS). The VAERS toll-free number is
1‑800‑822‑7967 or report online to
https://vaers.hhs.gov/reportevent.html . Please include "Novavax
COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA" in the first
line of box #18 of the report form.
In addition, you can report side effects to Novavax, Inc., using
the following contact information: Website: www.NovavaxMedInfo.com,
Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX
(1-844-668-2829).
What about pregnancy or breastfeeding?
If you or your child are pregnant or breastfeeding, discuss the
options with your healthcare provider.
There is a pregnancy exposure registry that monitors pregnancy
outcomes in women exposed to the Novavax COVID-19 Vaccine,
Adjuvanted during pregnancy. Women who are vaccinated with the
Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are
encouraged to enroll in the registry by visiting
https://c-viper.pregistry.com.
Please see the Fact Sheet for Recipients and
Caregivers for more information. Reporting Adverse Events and
Vaccine Administration Errors
- Adverse events can also be reported to Novavax, Inc. using the
following contact information or by providing a copy of the VAERS
form to Novavax, Inc. Website:
https://www.novavaxmedinfo.com/, Fax Number: 1-888-988-8809,
Telephone Number: 1-844-NOVAVAX (1-844-668-2829).
About Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19
Vaccine (recombinant, adjuvanted) (NVX-CoV2601)
NVX-CoV2601
is an updated version of Novavax's prototype COVID-19 vaccine
(NVX-CoV2373) formulated to target the Omicron XBB.1.5 subvariant.
It 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 Matrix-M™ Adjuvant
When added to vaccines,
Novavax's patented saponin-based Matrix-M adjuvant enhances the
immune system response, making it 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 help 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-19, influenza and COVID-19 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
scope, timing and outcome of future regulatory filings and actions,
including the availability of its Novavax COVID-19 Vaccine,
recombinant, adjuvanted (2023-2024 Formula) (NVX-CoV2601), its
coordination with certain countries and the timing of delivery and
distribution of its vaccine, including plan to have its vaccine
available in Europe in the coming
weeks, 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; challenges or delays in
obtaining regulatory authorization for its product candidates,
including its updated XBB version of its COVID-19 vaccine in time
for the fall 2023 vaccination season or for future COVID-19 variant
strain changes; challenges or delays in clinical trials;
manufacturing, distribution or export delays or challenges;
Novavax's exclusive dependence on Serum Institute of India Pvt.
Ltd. for co-formulation and filling and the impact of any delays or
disruptions in their operations on the delivery of customer orders;
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
References:
- Wherry EJ, Barouch DH. T cell immunity to COVID-19
vaccines. Science. 2022;377(6608):821-822.
doi:10.1126/science.add2897.
- 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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