GAITHERSBURG, Md., Nov. 28, 2023 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a global company advancing protein-based vaccines
with its Matrix-M™ adjuvant, today announced that Nuvaxovid™
XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency
Use Listing (EUL) by the World Health Organization (WHO) for active
immunization to prevent COVID-19 in individuals aged 12 and older.
The EUL assists WHO member states in assessing vaccines with the
aim of expediting availability and enables the WHO's 194 member
states to expedite regulatory approvals to import and administer
the vaccine.
"The WHO Emergency Use Listing of our updated protein-based
non-mRNA COVID-19 vaccine enables expedited regulatory approvals
for its 194 member states and UN procurement agencies, such as
UNICEF, thereby supporting equitable access to our vaccine around
the world," said John C. Jacobs,
President and Chief Executive Officer, Novavax. "Rural or
hard-to-reach areas can benefit from our vaccine's ease of
transport and storage profile. As part of a diversified vaccine
portfolio, our vaccine can play an important role in helping to
protect people around the globe against the latest variants."
Novavax's vaccine can be stored at 2 to 8 degrees Celsius and
has a 12-month shelf life, simplifying delivery, decreasing the
carbon footprint and reducing wastage.1-4
The EUL was based on non-clinical data showing that
Novavax's 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 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 currently
circulating variants.5,6
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 updated COVID-19 vaccine is also authorized in the
U.S. and the European Union, and is under review in other
markets.
Trade Name in the U.S.
The trade name Nuvaxovid™ has
not been approved by the U.S. Food and Drug Administration
(FDA).
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 Emergency
Use Authorization (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 18008227967
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 2023-2024 Formula (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-19.
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, including the availability of its updated XBB
version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024
Formula) (NVX-CoV2601) and the timing of delivery and distribution
of its vaccine 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:
- Council of the European Union. (2021). How protein-based
vaccines work against
COVID-19. https://www.consilium.europa.eu/en/infographics/covid-19-protein-based-vaccine/.
- Cid R, Bolívar J. Platforms for Production of Protein-Based
Vaccines: From Classical to Next-Generation Strategies.
Biomolecules. 2021 Jul 21;11(8):1072. doi:
10.3390/biom11081072.
- Uddin MN, Roni MA. Challenges of Storage and Stability of
mRNA-Based COVID-19 Vaccines. Vaccines (Basel). 2021 Sep 17;9(9):1033. doi:
10.3390/vaccines9091033.
- Kurzweil P, Müller A, Wahler S. The Ecological Footprint of
COVID-19 mRNA Vaccines: Estimating Greenhouse Gas Emissions in
Germany. Int J Environ Res
Public Health. 2021 Jul 12;18(14):7425. doi:
10.3390/ijerph18147425.
- 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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