Immunizations with Nuvaxovid™ to begin in coming
days
GAITHERSBURG, Md., Feb. 23, 2022 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced the first doses of Nuvaxovid™ COVID-19
Vaccine (recombinant, adjuvanted) have begun shipping to European
Union (EU) member states. Nuvaxovid, also known as
NVX-CoV2373, is the first protein-based COVID-19 vaccine
authorized for use in Europe.
Local test and release procedures were completed and Nuvaxovid
doses are shipping from Novavax' Netherlands distribution center to EU member
states beginning this week. The first wave of shipments includes
several countries, such as Germany, France and Austria. Shipments to additional EU member
states are expected to quickly follow.
"Today's announcement paves the way for vaccination with
Nuvaxovid to begin in Europe
within the coming days. The Novavax COVID-19 vaccine provides a
differentiated option to bolster vaccination rates across
Europe," said Stanley C.
Erck, President and Chief Executive Officer, Novavax. "Nuvaxovid
has demonstrated efficacy, a reassuring safety and tolerability
profile, and is built on a well-understood protein-based vaccine
platform used for other vaccines for decades."
The European Commission (EC) granted conditional marketing
authorization (CMA) for Nuvaxovid for active immunization to
prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of
age and older. The authorization followed the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) recommendation to authorize the vaccine and is
applicable in all 27 EU member states. Novavax expects to submit
its regulatory filing for a pediatric indication in adolescents
aged 12 through 17-years to global regulatory authorities,
including EMA, during the first quarter of 2022.
Novavax and the EC have an advance purchase agreement for
up to 100 million doses of Nuvaxovid with the option for an
additional 100 million doses (up to 200 million doses total).
Through the second quarter, Novavax has received a commitment for
orders from the EC totaling 69 million doses. The initial doses
were manufactured by Novavax' partner, the Serum Institute of
India, the world's largest vaccine
manufacturer by volume. Information about dose administration will
be available through each member state.
For more information on Nuvaxovid, including the European
approved Product Information, European approved Consumer Medicines
Information and Important Safety Information, or to request
additional information, please visit the following websites:
- European Medicines Agency website
- Novavax global authorization website
The brand name Nuvaxovid™ has not yet been authorized for use in
the U.S. by the FDA.
Authorized Use of Nuvaxovid™ in the European
Union
European Commission has granted conditional marketing
authorization for Nuvaxovid™ COVID-19 Vaccine (recombinant,
adjuvanted) for active immunization to prevent COVID-19 caused by
SARS-CoV-2 in individuals 18 years of age and older.
Important Safety Information
- Nuvaxovid™ is contraindicated in persons who
have a hypersensitivity to the active substance or to any of the
excipients
- Events of anaphylaxis have been reported with administration of
COVID-19 vaccines. Appropriate medical treatment and supervision
should be available in case of an anaphylactic reaction
- Anxiety-related reactions, including vasovagal reactions
(syncope), hyperventilation, or stress–related reactions may occur
in association with vaccination as a response to the needle
injection. It is important that precautions are in place to avoid
injury from fainting
- Vaccination should be postponed in individuals suffering from
an acute severe febrile illness or acute infection
- Give Nuvaxovid with caution in individuals receiving
anticoagulant therapy or those with thrombocytopenia or any
coagulation disorder (such as haemophilia) because bleeding or
bruising may occur following an intramuscular administration in
these individuals
- The efficacy of Nuvaxovid may be lower in immunosuppressed
individuals
- The duration of protection afforded by the vaccine is unknown
as it is still being determined by ongoing clinical trials
- Individuals may not be fully protected until 7 days after their
second dose. As with all vaccines, vaccination with Nuvaxovid may
not protect all vaccine recipients
- The most common adverse reactions observed during clinical
studies (frequency category of very common ≥ 1/10), were headache,
nausea or vomiting, myalgia, arthralgia, injection site
tenderness/pain, fatigue and malaise
About NVX-CoV2373
NVX-CoV2373 is a protein-based
vaccine engineered from the genetic sequence of the first strain of
SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was
created using Novavax' recombinant nanoparticle technology to
generate antigen derived from the coronavirus spike (S) protein and
is formulated with Novavax' patented saponin-based Matrix-M™
adjuvant to enhance the immune response and stimulate high levels
of neutralizing antibodies. NVX-CoV2373 contains purified protein
antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid
formulation in a vial containing ten doses. The vaccination regimen
calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M
adjuvant) given intramuscularly 21 days apart. The vaccine is
stored at 2°- 8° Celsius, enabling the use of existing vaccine
supply and cold chain channels. Use of the vaccine should be in
accordance with official recommendations.
Novavax has established partnerships for the manufacture,
commercialization and distribution of NVX-CoV2373 worldwide.
Existing authorizations leverage Novavax' manufacturing partnership
with Serum Institute of India
(SII), the world's largest vaccine manufacturer by volume. They
will later be supplemented with data from additional manufacturing
sites throughout Novavax' global supply chain.
About Matrix-M™ Adjuvant
Novavax' patented
saponin-based Matrix-M™ adjuvant has demonstrated a potent and
well-tolerated effect by stimulating the entry of
antigen-presenting cells into the injection site and enhancing
antigen presentation in local lymph nodes, boosting immune
response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a
biotechnology company that promotes improved health globally
through the discovery, development and commercialization of
innovative vaccines to prevent serious infectious diseases. The
company's proprietary recombinant technology platform harnesses the
power and speed of genetic engineering to efficiently produce
highly immunogenic nanoparticles designed to address urgent global
health needs. NVX-CoV2373, the company's COVID-19 vaccine, has
received conditional authorization from multiple regulatory
authorities globally, including the European Commission and the
World Health Organization. The vaccine is also under review by
multiple regulatory agencies worldwide. In addition to its COVID-19
vaccine, Novavax is also currently evaluating a COVID-seasonal
influenza combination vaccine in a Phase 1/2 clinical trial, which
combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza
investigational vaccine candidate. These vaccine candidates
incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant
to enhance the immune response and stimulate high levels of
neutralizing antibodies.
For more information, visit www.novavax.com and
connect with us on LinkedIn.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, its
partnerships, the ongoing development of NVX-CoV2373, including a
COVID-seasonal influenza combination vaccine candidate with
NanoFlu, its quadrivalent influenza investigational vaccine
candidate, the scope, timing and outcome of future regulatory
filings and actions, including Novavax' plans to submit global
regulatory filings for a NVX-CoV2373 pediatric indication during
the first quarter of 2022, and supplement existing authorizations
with data from the additional manufacturing sites in Novavax'
global supply chain, the potential impact of Novavax and
NVX-CoV2373 in addressing vaccine access, controlling the pandemic,
and protecting populations, the efficacy, safety, and intended
utilization of NVX-CoV2373, and the expected delivery of
NVX-CoV2373 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 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 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' Annual
Report on Form 10-K for the year ended December 31, 2020 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
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey |
202-709-7521
media@novavax.com
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