- Nuvaxovid™ is the first protein-based COVID-19
vaccine available for use in adolescents aged 12 through 17 in
Australia
GAITHERSBURG, Md., July 26,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced the Australian Therapeutic Goods Agency
(TGA) has granted expanded approval for provisional registration of
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)
to adolescents aged 12 through 17.
"Today's provisional registration of Nuvaxovid for adolescents
is timely with Australia's current
winter surge of COVID-19 and the return to schools," said
Stanley C. Erck, President and Chief
Executive Officer, Novavax. "We are committed to reducing the
burden of COVID-19 and believe that our vaccine, developed using an
innovative approach to traditional technology, may help increase
the adolescent vaccination rate."
The provisional registration was based on data from the ongoing
pediatric expansion of PREVENT-19, a pivotal Phase 3 trial of 2,247
adolescents aged 12 through 17 years across 73 sites in the U.S.,
to evaluate the safety, effectiveness (immunogenicity), and
efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved its primary
effectiveness endpoint and demonstrated 80% clinical efficacy
overall at a time when the Delta variant was the predominant
circulating SARS-CoV-2 strain in the U.S.
Preliminary safety data from the trial showed the vaccine to be
generally well-tolerated. Serious and severe adverse events 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 common adverse reactions
observed were injection site tenderness/pain, headache, myalgia,
fatigue, and malaise. There was no increase in reactogenicity in
younger (12 to <15 years old) adolescents compared to older (15
to <18 years old) adolescents. No new safety signal was observed
through the placebo-controlled portion of the study.
In the 12 through 17 year-old population, Nuvaxovid has also
been conditionally authorized in the European Union and
granted emergency use authorization in India, and is under review in other
markets.
The TGA granted provisional registration in January 2022 for use
of Nuvaxovid in adults aged 18 and older and for use as a
heterologous and homologous booster in June 2022.
Novavax' sponsor in Australia
is Biocelect Pty. Ltd.
▼ This vaccine is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals
are asked to report any suspected adverse events at
www.tga.gov.au/reporting-problems.
Trade Name in the U.S.
The trade name Nuvaxovid™ has
not yet been approved by the U.S. Food and Drug Administration.
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 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 website:
About the Novavax COVID-19 vaccine (NVX-CoV2373)
The
Novavax COVID-19 vaccine (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 (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. The Novavax COVID-19 vaccine contains
purified protein antigen and can neither replicate, nor can it
cause COVID-19.
The 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. Use of the vaccine should be in
accordance with official recommendations.
Novavax has established partnerships for the manufacture,
commercialization and distribution of its COVID-19 vaccine
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 Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3
Trials
The Novavax COVID-19 vaccine (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, the Novavax
COVID-19 vaccine 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 the Novavax COVID-19 vaccine with
Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years
of age in 73 locations in the United
States, 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., EC and the WHO. 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 a COVID-seasonal influenza combination vaccine
candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373
and NanoFlu*, its quadrivalent influenza investigational vaccine
candidate, and is also evaluating an Omicron strain-based vaccine
(NVX-CoV2515) as well as a bivalent 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.
*NanoFlu identifies a recombinant hemagglutinin (HA) protein
nanoparticle influenza vaccine candidate produced by Novavax. This
investigational candidate was evaluated during a controlled phase 3
trial conducted during the 2019-2020 influenza season.
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, including an Omicron strain based
vaccine and bivalent Omicron-based / original strain based vaccine,
a COVID-seasonal 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 and intended
utilization of NVX-CoV2373, 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
Alex Delacroix | 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.