GAITHERSBURG, Md., Nov. 18,
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 granted expanded authorization 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 homologous booster in
adults aged 18 and older.
"Canadians now have access to our protein-based Nuvaxovid
COVID-19 vaccine as an adult booster," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "With the winter months upon us, it's important
to have options for vaccination to help protect against
COVID-19."
The expanded authorization was based on data from a Phase 2
trial conducted in South
Africa and from the Prevent-19 Phase 3 trial conducted in
the U.S. and Mexico. As part of
the trials, a single booster dose of Nuvaxovid was administered to
healthy adult participants approximately six to 11 months after
their primary series of two doses administered three weeks apart.
The third (booster) dose produced increased immune responses
to levels comparable to or exceeding those associated with
protection against COVID-19 in Phase 3 clinical trials.
In the 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. The most frequent adverse reactions were
injection site tenderness (68%), injection site pain (56%), fatigue
(45%), myalgia (44%), headache (41%), malaise (35%), arthralgia
(20%), and nausea or vomiting (11%). Following the booster
vaccination in adults, frequencies and severity (all grades) of
solicited adverse events generally increased, with most events
being mild to moderate in severity.
Novavax' vaccine has been authorized as a heterologous and
homologous booster in the U.S., European Union, United Kingdom (U.K.), Japan, Australia, New
Zealand, and Switzerland, and a number of other countries
have policy recommendations allowing use of the vaccine as a
heterologous or homologous booster dose. Novavax has ongoing trials
to further explore the vaccine's immunogenicity and safety as
a heterologous booster.
Health Canada previously
authorized Nuvaxovid as a primary series in adults aged 18 and
older in February 2022. Novavax filed
in Canada for the vaccine's use as
a primary series in adolescents aged 12 through 17 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).
Authorized Use of Nuvaxovid™ in Canada
Health Canada has granted
authorization for registration of Nuvaxovid™ COVID-19 Vaccine
(Recombinant protein, Adjuvanted) to COVID-19 caused by SARS-CoV-2
as a primary series 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,
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.