GAITHERSBURG, Md., Dec. 7, 2022
/CNW/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company
dedicated to developing and commercializing next-generation
vaccines for serious infectious diseases, today announced that
Health Canada has approved a supplement to a New Drug Submission
(sNDS) for Nuvaxovid™ (COVID-19 Vaccine (Recombinant protein,
Adjuvanted)) (NVX-CoV2373) for active immunization to prevent
coronavirus disease 2019 (COVID-19) caused by the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series
of two doses in adolescents aged 12 through 17.
"With the winter COVID-19 surge upon us, it's more important now
than ever to ensure adolescents have access to COVID-19 vaccine
options, including Nuvaxovid," said Stanley
C. Erck, President and Chief Executive Officer, Novavax.
"Our vaccine is developed using an innovative approach to
traditional vaccine technology and may have a special role to play
in adolescent vaccination based on parents' and caregivers'
familiarity with protein-based vaccines used in other disease
areas."
The approval of the sNDS was 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, the effectiveness analysis was based on
antibody titers that were shown to be higher in adolescents than in
young adults. Effectiveness was supported by clinical efficacy
showing that Nuvaxovid provided clinical protective efficacy of
79.5% (95% CI: 46.8%, 92.1%) overall at a time when the Delta
variant was the predominant circulating SARS-CoV-2 strain.
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. The most frequent ARs in
participants aged 12 through 17 were injection site tenderness
(71%), injection site pain (67%), headache (63%), myalgia (57%),
fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia
(19%), injection site swelling (19%), pyrexia (17%), and injection
site redness (17%). Most were mild-to-moderate in severity and
lasted less than two days. No new safety concerns were observed
through the placebo-controlled portion of the pediatric
expansion.
In the 12 through 17-year-old population, Novavax' vaccine has
been authorized in more than 10 markets around the world including
the U.S., the European Union, and the United Kingdom.
Health Canada previously
approved Nuvaxovid as a primary series in adults aged 18 and older
in February 2022 and as a
homologous booster in adults in November
2022. In Canada, Nuvaxovid
will be manufactured locally at the Biologics Manufacturing Centre
in Montreal. Engineering runs have
been successfully completed and manufacturing of process
performance qualification batches is expected to begin in early
2023.
Trade Name in the U.S.
The trade name Nuvaxovid™ has
not yet been approved by the U.S. Food and Drug Administration
(FDA).
Authorized Use of Nuvaxovid™ in Canada
Health Canada has approved registration of Nuvaxovid™
COVID-19 Vaccine (Recombinant protein, Adjuvanted) to COVID-19
caused by SARS-CoV-2 as a primary series in individuals 12 years of
age and older, and as a homologous booster dose in individuals 18
years of age and older. There are no data available on the
interchangeability of Nuvaxovid with other COVID- 19 vaccines to
complete the primary vaccination series.
Important Safety Information: Canada
- Nuvaxovid is contraindicated in individuals who are
hypersensitive to the active ingredient or to any ingredients in
the formulation, including any non-medicinal ingredient, or
component of the container.
- Vaccination should be postponed in individuals suffering from
an acute severe febrile illness or acute infection.
- Individuals may not be optimally protected until seven days
after their second dose.
- 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 Nuvaxovid.
- 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 effects with Nuvaxovid may temporarily affect the ability
to drive or use machines.
- Immunocompromised persons, including individuals receiving
immunosuppressant therapy, may have a diminished immune response to
the vaccine.
- Anxiety-related reactions, including vasovagal reactions,
hyperventilation, or stress–related reactions may occur in
association with vaccination. Syncope (fainting) can occur
following, or even before, any vaccination as a psychogenic
response to the needle injection. It is important that precautions
are in place to avoid injury from fainting and manage syncopal
reactions.
- Administration of Nuvaxovid in pregnancy should only be
considered when the potential benefits outweigh any potential risks
for the mother and fetus.
- The most common adverse reactions observed during clinical
studies were injection site tenderness, injection site pain,
fatigue, myalgia, headache, malaise, arthralgia, and nausea or
vomiting.
For more information on Nuvaxovid, including the Summary of
Product Characteristics with Package Leaflet, adverse event
reporting instructions, or to request additional information,
please visit the following websites:
- Health Canada
- 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
disease. 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 the 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 the Novavax COVID-19 vaccine 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 (CIC) 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 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 or Giovanna Chandler | 202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.