- Novavax's updated vaccine will be available at vaccination
centers across Taiwan
GAITHERSBURG, Md., Dec. 18,
2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
global company advancing protein-based vaccines with its
Matrix-M™ adjuvant, today announced that the Taiwan
Food and Drug Administration has granted emergency use
authorization for Nuvaxovid™ XBB.1.5 dispersion for
injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601)
for active immunization to prevent COVID-19 in individuals aged 12
and older.
Doses of Novavax's updated vaccine will be delivered to
Taiwan under an existing advanced
purchase agreement and will be widely available at vaccination
centers across Taiwan. More
information is available from the Taiwan Centers for Disease
Control.
"We are working closely with Taiwan's authorities to ensure doses of our
updated protein-based non-mRNA COVID-19 vaccine are made available
at vaccination centers across Taiwan as soon as possible," said John C. Jacobs, President and Chief Executive
Officer, Novavax. "As we head into the holiday season with more
time spent together and indoors, COVID-19 infection rates are
likely to rise and our best line of defense is vaccination."
Authorization was based on non-clinical data showing that
Novavax's updated COVID-19 vaccine induced functional immune
responses for 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 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 updated COVID-19 vaccine is also authorized in the
U.S., the European Union, Canada and by the World Health Organization,
and is under review in other markets.
Trade Name in the U.S.
The trade name
Nuvaxovid™ has not yet been approved by the U.S. Food
and Drug Administration (FDA).
NOVAVAX COVID-19 VACCINE 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 in Taiwan, recombinant, adjuvanted (2023-2024
Formula) (NVX-CoV2601), its coordination with certain countries 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:
- 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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SOURCE NOVAVAX, INC