Novavax COVID-19 Vaccine Nuvaxovid(TM) Recommended for Expanded Conditional Marketing Authorization in EU by CHMP for Adolescents Aged 12 Through 17
PR96690
Novavax COVID-19 Vaccine Nuvaxovid(TM) Recommended for Expanded Conditional Marketing Authorization in the European Union by CHMP for Adolescents Aged 12 Through 17
GAITHERSBURG, Md., June 24, 2022 /PRNewswire=KYODO JBN/ --
--Upon authorization, Nuvaxovid(TM) would be the first protein-based option for
adolescents aged 12 through 17 in Europe
--Nuvaxovid(TM) demonstrated 80% efficacy and was generally well-tolerated in
adolescents
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that the Nuvaxovid(TM) (NVX-CoV2373) COVID-19 vaccine has been
recommended for expanded conditional marketing authorization (CMA) in the
European Union (EU) for adolescents aged 12 through 17. The Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency based
its opinion on results from the Phase 3 PREVENT-19 clinical trial.
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"This recommendation brings us closer to offering adolescents in the EU the
first protein-based COVID-19 vaccine developed using an innovative approach to
traditional technology," said Stanley C. Erck, President and Chief Executive
Officer, Novavax.
The CHMP recommendation 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 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. Fever was
seen more frequently in adolescents than in adults. These effects are usually
mild or moderate and improve within a few days from the vaccination.
The European Commission (EC) granted CMA for Nuvaxovid to prevent COVID-19 in
people 18 years of age and over in December 2021 (
).
In the 12 through 17 year-old population, emergency use authorization (
) has been granted in India.
Authorization in the U.S.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use
in the U.S. and 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 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 additional information on Nuvaxovid, please visit the following websites:
-- Novavax global authorization website (
)
-- European Medicines Agency (
)
-- European Commission (
)
About NVX-CoV2373
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. NVX-CoV2373 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 NVX-CoV2373 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 NVX-CoV2373 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 United States, compared with placebo. In
the pediatric trial, NVX-CoV2373 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.
PREVENT-19 is being conducted with support from the U.S. government, including
the Department of Defense, the Biomedical Advanced Research and Development
Authority (BARDA), part of the Office of the Assistant Secretary for
Preparedness and Response at the U.S. Department of Health and Human Services
(HHS), and the National Institute of Allergy and Infectious Diseases, part of
the National Institutes of Health at HHS. BARDA is providing up to $1.75
billion under a Department of Defense agreement (# MCDC2011-001).
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(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. NVX-CoV2373, the company's
COVID-19 vaccine, has received conditional authorization from multiple
regulatory authorities globally, including the European Commission and the
World Health Organization. The vaccine is currently under review by multiple
regulatory agencies worldwide and will soon be under review in the U.S. for use
in adults, 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 timing of clinical trial results, the ongoing
development of NVX-CoV2373, a COVID-seasonal influenza investigational
combination 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
adolescents, the potential impact and reach of Novavax and NVX-CoV2373 in
addressing vaccine access, controlling the pandemic and protecting populations,
and the efficacy, safety and intended utilization 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; 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 | +1 240-720-7804
media@novavax.com
SOURCE: Novavax, Inc.
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