Novavax Nuvaxovid(TM) COVID-19 Vaccine Conditionally Authorized in the European Union for Adolescents Aged 12 Through 17
PR96872
GAITHERSBURG, Md., July 6, 2022 /PRNewswire=KYODO JBN/ --
-- Nuvaxovid(TM) COVID-19 vaccine is the first protein-based option for
adolescents aged 12 through 17 in Europe
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that the European Commission (EC) has approved the expanded
conditional marketing authorization (CMA) of Nuvaxovid(TM) (NVX-CoV2373)
COVID-19 vaccine in the European Union (EU) for adolescents aged 12 through 17.
The approval follows the positive recommendation made by the European Medicines
Agency's Committee for Medicinal Products for Human Use on June 23, 2022 (
).
"With this authorization, we are extremely pleased to be able to offer our
Nuvaxovid COVID-19 vaccine to adolescents in the EU," said Stanley C. Erck,
President and Chief Executive Officer, Novavax. "Our protein-based vaccine was
developed using an innovative approach to traditional technology and has
demonstrated efficacy and safety in both adolescents and adults."
The authorization 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.
The EC granted CMA for Nuvaxovid to prevent COVID-19 in individuals aged 18 and
over in December 2021 (
). In addition to the EC's expanded CMA, India (
) has granted emergency use authorization in the 12 through 17 year-old
population.
Authorization in the U.S.
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:
-- European Medicines Agency (
)
-- European Commission (
)
-- Novavax global authorization website (
)
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.
Contacts:
Investors
Alex Delacroix | +1 240-268-2022
ir@novavax.com
Media
Ali Chartan | +1 240-720-7804
media@novavax.com
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SOURCE Novavax, Inc.
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