- Nuvaxovid™ is the first protein-based COVID-19 vaccine
approved for use in adolescents in Japan
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 that Nuvaxovid™ (NVX-CoV2373) COVID-19
vaccine received expanded manufacturing and marketing approval from
the Japan Ministry of Health, Labour and Welfare (MHLW) for primary
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. Novavax has partnered with
Takeda to develop, manufacture, and distribute Nuvaxovid in
Japan.
"We are pleased to work with Takeda to offer Nuvaxovid™, a
protein-based vaccine, to adolescents in Japan," said Stanley
C. Erck, President and Chief Executive Officer, Novavax. "As
COVID-19 continues to surge in the country, this approval offers
another option to help protect the health of the people of
Japan and help bolster the
vaccination rate."
The expanded approval 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.
Novavax licensed and transferred its manufacturing technologies
and is supplying the Matrix-M™ adjuvant to enable Takeda to
manufacture the vaccine at its Hikari facility.
In the 12 through 17 year-old population, Nuvaxovid has been
granted conditional authorization in the European Union, emergency
use authorization in India,
and provisional registration in Australia, and is actively under review in
other markets.
The MHLW previously approved Nuvaxovid for individuals aged 18
and older in April 2022.
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 7 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 TAK-019 Clinical
Trial
This placebo-controlled Phase 1/2 study (ClinicalTrials.gov
identifier NCT04712110) in Japan evaluated the safety and immunogenicity
of two vaccinations of TAK-019 given 21 days apart. The first of
200 subjects aged 20 years and older was dosed in Japan on February 24, 2021, and each
participant was assigned to receive a placebo or a 0.5 ml dose of
TAK-019 at both vaccinations. Participants Subjects were followed
for 12 months after the second dose of investigational product.
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 older 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 older 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., 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 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 potential for
subsequent orders from the U.S. government for additional doses of
NVX-CoV2373 and other potential formulations, 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 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
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.