GAITHERSBURG, Md., Sept. 16,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced that the Taiwan Food and Drug
Administration (TFDA) has granted expanded emergency use
authorization (EUA) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine
for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by the severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.
"In Taiwan, we have seen strong use of our protein-based
COVID-19 vaccine in adults and are pleased to expand availability
to adolescents aged 12 through 17 as we prepare for more time spent
indoors during the fall and winter months and possible COVID-19
surges," said Stanley C. Erck,
President and Chief Executive Officer, Novavax. "We believe that
our vaccine, developed using an innovative approach to traditional
technology, may help increase adolescent vaccination rates."
The EUA is based on data from the ongoing pediatric expansion of
the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through
17 years across 75 sites in the U.S., to evaluate the safety and
effectiveness of Nuvaxovid. In the pediatric expansion, Nuvaxovid
achieved its primary efficacy endpoint with clinical efficacy of
78.29% (95% CI: 37.55%, 92.45%) overall at a time when the Delta
variant was the predominant circulating SARS-CoV-2 strain in the
U.S. The efficacy analysis was supported by assessment of antibody
titers that were shown to be higher in adolescents than in young
adults.
Preliminary safety data from the pediatric expansion showed the
vaccine to be generally well-tolerated. Serious and severe adverse
reactions (AR) were low in number and balanced between vaccine and
placebo groups, and not considered related to the vaccine. Local
and systemic reactogenicity was generally lower than or similar to
adults, after the first and second dose. Among participants 12
through 17 years of age, solicited ARs following administration of
any dose of the vaccine were injection site pain/tenderness
(75.0%), headache (56.9%), fatigue/malaise (57.9%), muscle pain
(49.0%), nausea/vomiting (19.9%), joint pain (16.2%), fever
(16.9%), injection site swelling (8.0%), and injection site redness
(7.5%). Most were mild-to-moderate in severity and lasted less than
two days. No new safety signal was observed through the
placebo-controlled portion of the pediatric expansion.
In the 12 through 17-year-old population, the vaccine has been
authorized in more than 10 markets including the U.S., the European
Union, and the United
Kingdom (U.K.).
The TFDA previously granted EUA for Nuvaxovid to prevent
COVID-19 in adults aged 18 and older in June
2022.
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
- 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 the vaccine.
- 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 frequent adverse reactions in adolescents 12 to 17
years of age were injection site tenderness, injection site pain,
headache, myalgia, fatigue, malaise, nausea or vomiting,
arthralgia, injection site swelling, pyrexia, and injection site
redness.
For more information on NVX-CoV2373 please visit the following
website:
- Novavax global authorization website
About Nuvaxovid™
(NVX-CoV2373)
Nuvaxovid 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. The vaccine 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. 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 10 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 NVX-CoV2373 Phase 3
Trials
NVX-CoV2373 continues being evaluated in two pivotal Phase 3
trials.
PREVENT-19 (the PRE-fusion protein
subunit Vaccine Efficacy Novavax Trial
| COVID-19) is a 2:1 randomized, placebo-controlled,
observer-blinded trial to evaluate the efficacy, safety, and
immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 29,960
participants 18 years of age and over in 119 locations in the
U.S. and Mexico. The primary endpoint for PREVENT-19 was
the first occurrence of PCR-confirmed symptomatic (mild, moderate,
or severe) COVID-19 with onset at least seven 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%. A secondary endpoint was 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. In the trial, NVX-CoV2373 achieved 90.4% efficacy
overall. It was generally well-tolerated and elicited a robust
antibody response after the second dose in both studies. Full
results of the trial were published in the New England
Journal of Medicine (NEJM).
The pediatric expansion of PREVENT-19 is a 2:1 randomized,
placebo-controlled, observer-blinded trial to evaluate the safety,
effectiveness, and efficacy of NVX-CoV2373 with Matrix-M
adjuvant in 2,247 adolescent participants 12 to 17 years of age in
73 locations in the U.S., compared with placebo. In the pediatric
trial, the vaccine achieved its primary effectiveness endpoint
(non-inferiority of the neutralizing antibody response compared to
young adult participants 18 through 25 years of age from
PREVENT-19) and demonstrated 80% efficacy overall at a time when
the Delta variant of concern was the predominant circulating strain
in the U.S. Additionally, immune responses were about
two-to-three-fold higher in adolescents than in adults against all
variants studied.
Additionally, a trial conducted in the U.K. with 14,039
participants aged 18 years and over 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 seven 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. 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 vaccine candidate in a Phase 1/2
clinical trial, 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 bivalent Omicron-based / original strain based
vaccine, a COVID-seasonal influenza combination 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 evolving COVID-19 pandemic, the potential
impact and reach of Novavax and NVX-CoV2373 in addressing vaccine
access, controlling the pandemic and protecting populations, the
efficacy, safety intended utilization, and the 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 or Giovanna Chandler | 202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.