Novavax Announces Expanded Approval of Nuvaxovid(TM) COVID-19 Vaccine for Adolescents Aged 12 through 17 in Japan
PR97197
GAITHERSBURG, Md., July 26, 2022 /PRNewswire=KYODO JBN/ --
-- Nuvaxovid(TM) is the first protein-based COVID-19 vaccine approved for use
in adolescents in Japan
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that Nuvaxovid(TM) (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(TM), 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
(https://c212.net/c/link/?t=0&l=en&o=3603602-1&h=1588304045&u=https%3A%2F%2Fir.novavax.com%2F2022-02-10-Novavax-Announces-Positive-Results-of-COVID-19-Vaccine-in-Pediatric-Population-of-PREVENT-19-Phase-3-Clinical-Trial&a=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(TM) 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 (https://c212.net/c/link/?t=0&l=en&o=3603602-1&h=3869587816&u=https%3A%2F%2Fir.novavax.com%2F2022-07-05-Novavax-Nuvaxovid-TM-COVID-19-Vaccine-Conditionally-Authorized-in-the-European-Union-for-Adolescents-Aged-12-Through-17&a=European+Union), emergency use authorization in India (https://c212.net/c/link/?t=0&l=en&o=3603602-1&h=789423915&u=https%3A%2F%2Fir.novavax.com%2F2022-03-22-Novavax-and-Serum-Institute-of-India-Announce-First-Emergency-Use-Authorization-of-Novavax-COVID-19-Vaccine-in-Adolescents-12-to-18-in-India&a=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
Trade Name in the U.S.
The trade name Nuvaxovid(TM) 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(TM) 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 degrees – 8 degrees 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 New England Journal of Medicine
( https://www.nejm.org/doi/full/10.1056/NEJMoa2116185?query=featured_home )
(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(TM) 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
(https://www.linkedin.com/company/novavax/ ).
*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 | +1 240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | +1 202-709-5563
media@novavax.com
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SOURCE Novavax, Inc.
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