GAITHERSBURG, Md., Jan. 18,
2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX),
a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced that partner SK bioscience has received
expanded manufacturing and marketing approval from the Korean
Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™
(NVX-CoV2373) for use as a booster for active immunization to
prevent COVID-19 in adults aged 18 and older. Prior to the
approval, in September 2022, the
Korean Centers for Disease Control and Prevention set out
recommendations that advised that Nuvaxovid could be used as a
booster in adults aged 18 and older.
"We are pleased to collaborate with SK bioscience to offer our
protein-based vaccine, Nuvaxovid, for use as a booster in adults
regardless of previous vaccine history," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "This is an important step in ensuring broad
access to diversified vaccine options."
This approval is based on data from Novavax' Phase 2 trial
conducted in the U.S. and Australia, from a separate Phase 2
trial conducted in South
Africa, and from the United
Kingdom-sponsored COV-BOOST trial. As part of the Novavax
Phase 2 trials, a single booster dose of Nuvaxovid was administered
to adult participants approximately six months after their primary
two-dose vaccination series of Nuvaxovid. The third dose produced
increased immune responses comparable to or exceeding levels
associated with protection in Phase 3 clinical trials. In the
COV-BOOST trial, Nuvaxovid induced a significant antibody response
when used as a booster dose following prior vaccination with other
authorized COVID-19 vaccines.
In the Novavax-sponsored trials, following the booster, local
and systemic reactions had a median duration of approximately two
days. The incidence of Grade 3 or higher events remained relatively
low. Safety reporting of reactogenicity events showed an increasing
incidence across all three doses of Nuvaxovid, often seen with
increased immunogenicity. Medically attended adverse events (AE),
potentially immune-mediated medical conditions, and severe AEs
occurred infrequently following the booster dose and were balanced
between vaccine and placebo groups.
Novavax' COVID-19 vaccine is authorized for use as an adult
booster in more than 35 countries, and a number of other countries
have policy recommendations allowing use of the vaccine as a
booster dose. The vaccine is actively under review in other markets
and has ongoing trials to further explore its efficacy and safety
as a booster.
KFMDS previously approved Nuvaxovid as a primary series in
adults aged 18 and older in January
2022 and as a primary series in adolescents aged 12
through 17 in August 2022. In Korea,
SK bioscience signed a licensing agreement with Novavax and is
manufacturing drug substance and drug product of Nuvaxovid for
domestic use.
Trade Name in the U.S.
The trade name
Nuvaxovid™ has not yet been approved by the U.S. Food and
Drug Administration (FDA).
Important Safety Information: South
Korea
- 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 following
the administration of the vaccine. Close observation for at least
15 minutes is recommended and a second dose of the vaccine should
not be given to those who have experienced anaphylaxis to the first
dose of Nuvaxovid.
- Anxiety-related reactions, including vasovagal reactions
(syncope), hyperventilation, or stress–related reactions may occur
in association with vaccination as a psychogenic 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. The presence of
a minor infection and/or low-grade fever should not delay
vaccination.
- Nuvaxovid should be given 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.
- Administration of Nuvaxovid in pregnancy should only be
considered when the potential benefits outweigh any potential risks
for the mother and foetus.
- The effects with Nuvaxovid may temporarily affect the ability
to drive or use machines.
- Individuals may not be fully protected until seven 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 were headache, nausea or vomiting, myalgia, arthralgia,
injection site tenderness/pain, fatigue, and malaise.
For more information on Nuvaxovid, including the Summary of
Product Characteristics with Package Leaflet, Prescribing
Information and Important Safety Information, adverse event
reporting instructions, or to request additional information,
please visit the following websites:
- KMFDS
- SK bioscience
- Novavax global authorization website
About Nuvaxovid™ (NVX-CoV2373)
Nuvaxovid
(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. The vaccine was created using
Novavax' recombinant nanoparticle technology to
generate antigen derived from the coronavirus spike protein and is
formulated with Novavax' patented saponin-based
Matrix-M™ adjuvant to enhance the immune response and
stimulate high levels of neutralizing antibodies. Nuvaxovid
contains purified protein antigen and can neither replicate,
nor can it cause COVID-19.
Nuvaxovid 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 Nuvaxovid worldwide.
Existing authorizations leverage Novavax' manufacturing partnership
with Serum Institute of India, 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. The Novavax COVID-19 vaccine, has
received authorization from multiple regulatory authorities
globally, including the U.S. FDA, the European Commission, and the
World Health Organization. The vaccine is currently under review by
multiple regulatory agencies worldwide, including for additional
indications and populations such as adolescents and as a booster.
In addition to its COVID-19 vaccine, Novavax is also
currently evaluating its COVID-19-Influenza Combination
(CIC) vaccine candidate, its quadrivalent
influenza investigational vaccine candidate, and an Omicron
strain-based vaccine (NVX-CoV2515) as well as a bivalent format
Omicron-based / original strain-based vaccine. 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 timing of clinical trial
results, the ongoing development of NVX-CoV2373, NVX-CoV2515 and a
bivalent Omicron-based / original strain based vaccine, the
CIC investigational vaccine candidate, a quadrivalent
influenza investigational vaccine candidate, the scope,
timing and outcome of future regulatory filings and actions,
including Novavax' plans to supplement existing
authorizations with data from the additional manufacturing sites
in Novavax' global supply chain, additional worldwide
authorizations of NVX-CoV2373 for use in adults and adolescents,
and as a booster, the potential impact and reach of Novavax
and NVX-CoV2373 in addressing vaccine access, increasing
vaccination rates, controlling the pandemic, and protecting
populations, the efficacy, safety, intended utilization, and
expected administration 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, 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; unanticipated
challenges or delays in conducting clinical trials; 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,
2021 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 and Giovanna Chandler |
202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.