- This Emergency Use Authorization and CDC recommendation
makes Novavax's vaccine the only protein-based non-mRNA COVID
vaccine option in the U.S.
- Novavax expects doses will be available in thousands of
locations across the U.S. in the coming days, including CVS
Pharmacy and Rite Aid
- Find Novavax's vaccine at us.novavaxcovidvaccine.com or
vaccines.gov
GAITHERSBURG, Md., Oct. 3, 2023 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a global company advancing protein-based vaccines
with its novel Matrix-M™ adjuvant, today announced that
the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)
(NVX-CoV2601) has received Emergency Use Authorization (EUA)
from the U.S. Food and Drug Administration (FDA) for active
immunization to prevent COVID-19 in individuals aged 12 and
older. Immediately upon authorization, Novavax's vaccine has also
been included in the recommendations issued by the U.S. Centers for
Disease Control and Prevention (CDC) on September 12, 2023.
Doses will be available nationwide at thousands of locations,
including national and local retail pharmacies and physicians'
offices, following the Center for Biologics Evaluation and Research
release of vaccine batches, expected in the coming days.
"COVID-19 is once again on the rise with infections and
hospitalizations increasing, so it's important that individuals get
vaccinated to protect themselves and their loved ones," said
John C. Jacobs, President and Chief
Executive Officer, Novavax. "Novavax's authorization today means
people will now have the choice of a protein-based non-MRNA option
to help protect themselves against COVID-19, which is now the
fourth leading cause of death in the U.S. In the coming days,
individuals in the U.S. can go to pharmacies, physicians' offices,
clinics and various government entities to receive an updated
Novavax vaccine."
The EUA 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 newly emerging subvariants BA.2.86, EG.5.1
FL.1.5.1 and XBB.1.16.6 as well as robust 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.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.
The EUA aligns with globally harmonized guidance from the FDA,
European Medicines Agency and the World Health Organization to
target the XBB strain this fall.3-5 Novavax is working
with these and other global regulatory authorities on
authorizations for its vaccine.
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 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, the scope, timing and outcome of future regulatory
filings and actions, 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 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
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.
- U.S. Food and Drug Administration (FDA). Updated COVID-19
vaccines for use in the United
States beginning in fall 2023. June
16,
2023. https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2023.
- European Medicines Agency (EMA). EMA and ECDC statement on
updating COVID-19 vaccines to target new SARS-CoV-2 virus variants.
June 6, 2023.
https://www.ema.europa.eu/en/news/ema-ecdc-statement-updating-covid-19-vaccines-target-new-sars-cov-2-virus-variants.
- World Health Organization (WHO). XBB.1.5 updated risk
assessment. June 20, 2023.
https://www.who.int/docs/default-source/coronaviruse/20230620xbb.1.5.pdf?sfvrsn=fff6f686_3.
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