- Novavax's updated COVID-19 vaccine is now available at a
wide range of retailers, including Costco, CVS Pharmacy, Giant,
Publix, Rite Aid, Stop & Shop and Topco
- Novavax's vaccine is the only protein-based non-mRNA
COVID-19 vaccine option in the U.S.
- Novavax's vaccine finder is available at
us.novavaxcovidvaccine.com
GAITHERSBURG, Md., Oct. 13,
2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a global company advancing protein-based vaccines with its
Matrix-M™ adjuvant, today announced that it has finalized
agreements with major pharmacy retailers and prominent Group
Purchasing Organizations (GPO) in the U.S. to provide the Novavax
COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)
(NVX-CoV2601) to prevent COVID-19 in individuals aged 12 and
older this vaccination season.
Through these agreements Novavax's updated COVID-19 vaccine will
be widely available across the U.S., including but not limited to,
Costco, CVS Pharmacy, Giant, Publix, Rite Aid, Stop & Shop and
Topco, a large retail purchaser for member
pharmacies. Novavax's vaccine received Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration
(FDA) on October 3, 2023.
"We are committed to ensuring immediate nationwide availability
of our protein-based non-mRNA vaccine, and our agreements with
leading U.S. pharmacy retailers will ensure people have options to
help protect themselves and their loved ones against COVID-19 this
fall," said John C. Jacobs,
President and Chief Executive Officer, Novavax. "Individuals will
have access to our protein-based vaccine through major pharmacies,
clinics, physicians' offices and government programs."
In addition to retail pharmacies, physicians' offices and public
health clinics, Novavax's vaccine will be available through various
government entities such as Vaccines for Children, Federal
Qualified Health Centers, Indian Health Services and the U.S.
Department of Defense. In addition, Novavax has donated product to
"Bridge Access Program For COVID Vaccines and Treatments" to
provide access for adults in the U.S. without other sources of
coverage.
Novavax continues to work with additional retailers and
anticipates that the network of partners providing its updated
COVID-19 vaccine will continue to grow. The Company will also
ensure its vaccine is available through GPO agreements, including
Vizient, Inc., Premier and Healthtrust Purchasing Group, which
provide broad access to the U.S. health system landscape.
Doses of Novavax's vaccine can be located
on us.novavaxcovidvaccine.com or vaccines.gov.
AUTHORIZED USE IN THE U.S.
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 2023-2024 Formula
(NVX-CoV2601)
NVX-CoV2601 is an updated version of
Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to
target the 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 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; manufacturing, distribution or
export delays or challenges; challenges in obtaining commercial
adoption of our updated protein-based non-mRNA XBB COVID-19
vaccine, NVX-CoV2373 or any COVID-19 variant strain-containing
formulation; 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