- Nuvaxovid™ COVID-19 vaccine is the first protein-based
option for adolescents aged 12 through 17 in Europe
GAITHERSBURG, Md., July 5, 2022
/CNW/ -- 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™ (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™ 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™
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™ 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.
*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 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 | 240-268-2022
ir@novavax.com
Media
Ali Chartan | 240-720-7804
media@novavax.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/novavax-nuvaxovid-covid-19-vaccine-conditionally-authorized-in-the-european-union-for-adolescents-aged-12-through-17-301580570.html
SOURCE Novavax, Inc.