GAITHERSBURG, Md., Jan. 12, 2022 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, and SK bioscience, Co. Limited, a vaccine business
subsidiary of Korea-based SK Group, today announced that
South Korea's Ministry of Food and
Drug Safety (MFDS) has approved a Biologics License Application
(BLA) from SK bioscience for Nuvaxovid™ COVID-19 Vaccine
(recombinant, adjuvanted) for active immunization in individuals 18
years of age and older for the prevention of COVID-19 caused by
SARS-CoV-2. Nuvaxovid™, Novavax' COVID-19 vaccine also known as
NVX-CoV2373, is the first protein-based COVID-19 vaccine to be
approved for commercial use in South
Korea and will be manufactured and marketed in the country
by SK bioscience.
"Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic
as both the Delta and Omicron variants have taken hold," said
Stanley C. Erck, President and Chief
Executive Officer, Novavax. "We thank our partners at SK bioscience
for their commitment to this public health challenge and the MFDS
for its thorough assessment of our data as we look forward to
helping address major obstacles to controlling the pandemic through
the additional option of our protein-based vaccine."
SK bioscience has an advance purchase agreement with the South
Korean government to supply 40 million doses of Novavax' vaccine.
The companies also recently announced expanded collaboration
and license agreements that are expected to increase manufacturing
capacity and provide SK bioscience with additional non-exclusive
territories.
Novavax' vaccine also recently received conditional
marketing authorization (CMA) in the European Union and
emergency use listing (EUL) from the World Health
Organization (WHO) under the brand name Nuvaxovid. The
Novavax/Serum Institute of India Pvt. Ltd. vaccine (brand name,
Covovax™) recently received emergency use authorization (EUA)
in India, Indonesia and the Philippines, as well as WHO EUL.
Together, the WHO EULs for the vaccine from both companies reflect
the potential opportunity for authorization in over 170 countries.
The vaccine is also currently under review by multiple additional
regulatory agencies worldwide and the company expects to receive
additional worldwide authorizations in the first half of 2022. This
includes the submission of its complete chemistry,
manufacturing and controls (CMC) data package to the U.S. Food and
Drug Administration (FDA) at the end of 2021. The company expects
to submit a request for EUA for the vaccine in the U.S. after one
month in accordance with guidance from the FDA regarding
submission of all EUA vaccines.
For more information, including details on Nuvaxovid and where
it has been authorized for use, please visit the following
websites:
- Novavax global authorization website
- South Korea Ministry of Food
and Drug Safety
- SK bioscience
The brand name Nuvaxovid has not yet been authorized for use in
the U.S. by the FDA.
Important Safety Information
- NVX-CoV2373 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. A second dose of the vaccine
should not be given to those who have experienced anaphylaxis to
the first dose of NVX-CoV2373.
- 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.
- NVX-CoV2373 should be given with caution in individuals
receiving anticoagulant therapy or those with thrombocytopenia or
any coagulation disorder (such as hemophilia) because bleeding or
bruising may occur following an intramuscular administration in
these individuals.
- The efficacy of NVX-CoV2373 may be lower in immunosuppressed
individuals.
- Administration of NVX-CoV2373 in pregnancy should only be
considered when the potential benefits outweigh any potential risks
for the mother and fetus.
- The effects with NVX-CoV2373 may temporarily affect the ability
to drive or use machines.
- Individuals may not be fully protected until 7 days after their
second dose. As with all vaccines, vaccination with NVX-CoV2373 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.
For additional information, please
visit www.NovavaxCovidVaccine.com for the full Summary of
Product Characteristics with Package Leaflet, Prescribing
Information and Important Safety Information, adverse event
reporting instructions, or to request additional information.
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. The current assigned shelf life of
the vaccine is 9 months.
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 the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is
being evaluated in two pivotal Phase 3 trials.
PREVENT-19, a trial in the U.S. and Mexico that
enrolled almost 30,000 participants, achieved 90.4% efficacy
overall. It was designed as a 2:1 randomized, placebo-controlled,
observer-blinded study to evaluate the efficacy, safety and
immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19
was the first occurrence of PCR-confirmed symptomatic (mild,
moderate or severe) COVID-19 with onset at least 7 days after the
second dose in serologically negative (to SARS-CoV-2) adult
participants at baseline. The statistical success criterion
included a lower bound of 95% CI >30%. The key secondary
endpoint is the prevention of PCR-confirmed, symptomatic moderate
or severe COVID-19. Both endpoints were assessed at least seven
days after the second study vaccination in volunteers who had not
been previously infected with SARS-CoV-2. It was generally
well-tolerated and elicited a robust antibody response in both
studies. Full results of the trial were published in
the New England Journal of
Medicine (NEJM).
A trial conducted in the U.K. with 14,039 participants was
designed as a randomized, placebo-controlled, observer-blinded
study and achieved overall efficacy of 89.7%. The primary endpoint
was based on the first occurrence of PCR-confirmed symptomatic
(mild, moderate or severe) COVID-19 with onset at least 7 days
after the second study vaccination in serologically negative (to
SARS-CoV-2) adult participants at baseline. Full results of the
trial were published in NEJM.
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, received
Conditional Marketing Authorization from the European Commission,
Emergency Use Listing from the World Health Organization, Emergency
Use Authorization in Indonesia and
the Philippines, and has been
submitted for regulatory authorization in multiple markets
globally. NanoFlu™, the company's quadrivalent influenza
nanoparticle vaccine, met all primary objectives in its pivotal
Phase 3 clinical trial in older adults. Novavax is currently
evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2
clinical trial, which combines the company's NVX-CoV2373 and
NanoFlu vaccine candidates. 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 Twitter, LinkedIn, Instagram and
Facebook.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, its
partnerships, the ongoing development of NVX-CoV2373, the scope,
timing and outcome of future regulatory filings and actions,
including Novavax' plans to supplement the CMC data submitted to
the MFDS with data from the additional manufacturing sites in
Novavax' global supply chain, and to submit an EUA application to
the U.S. FDA after one month, 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 increase to
manufacturing capacity 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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SOURCE Novavax, Inc.