GAITHERSBURG, Md., Nov. 29,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced that the World Health Organization (WHO)
has issued an updated Emergency Use Listing (EUL) for Nuvaxovid™
(NVX-CoV2373) COVID-19 vaccine for active immunization to prevent
coronavirus disease 2019 (COVID-19) caused by the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series
of two doses in adolescents aged 12 through 17 and as a booster in
adults aged 18 and older.
"Today's updated Emergency Use Listing from the WHO allows us to
offer our protein-based vaccine as a primary series to adolescents
and as a booster for adults around the world," said Stanley C. Erck, President and Chief Executive
Officer, Novavax. "WHO member countries now have a vaccine option
for these indications developed using an innovative approach to
traditional technology that can also be stored in standard
refrigeration, making it easy to transport."
Primary Series in Adolescents
The updated
EUL for Nuvaxovid as a primary series in
adolescents aged 12 through 17 was based on data from the
ongoing pediatric expansion of the Phase 3
PREVENT-19 trial of 2,232 adolescents aged 12 through 17 years
across 75 sites in the U.S., to evaluate the safety and
effectiveness of Nuvaxovid. In the pediatric
expansion, 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 pediatric expansion 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 pediatric expansion.
Booster in Adults
The updated EUL
for Nuvaxovid as a booster in adults aged 18 and
older is supported by data from Novavax' Phase
2 trial conducted in Australia, from a separate Phase 2 trial
conducted in South Africa, and
from the United Kingdom
(U.K.)-sponsored COV-BOOST trial. As part
of the Novavax Phase 2 trials, a single booster dose
of Nuvaxovid was administered to healthy adult
participants approximately six months after their primary two-dose
vaccination series of Nuvaxovid. The third dose
produced increased immune responses comparable to or exceeding
levels associated with protection in Phase 3 clinical trials. In
the COV-BOOST trial, Nuvaxovid induced a
meaningful antibody response when used as a heterologous
third booster dose.
In the Novavax-sponsored trials, following the booster, local
and systemic reactions had a median duration of approximately two
days. The incidence of Grade 3 or higher events remained relatively
low. Safety reporting of reactogenicity events showed an increasing
incidence across all three doses of Nuvaxovid, often seen with
increased immunogenicity. Medically attended adverse events (AE),
potentially immune-mediated medical conditions, and severe AEs
occurred infrequently following the booster dose and were balanced
between vaccine and placebo groups.
In the 12 through 17-year-old population, Novavax' vaccine has
been authorized in more than 10 markets including the U.S., the
European Union (EU), and the U.K. The vaccine has also been
authorized as a booster in the U.S., EU, Japan, Australia, New
Zealand, and Switzerland, and a number of other countries
have policy recommendations allowing use of the vaccine as a
heterologous or homologous booster dose. Novavax' vaccine is
actively under review in other markets for both indications and has
ongoing trials to further explore its efficacy and safety as a
booster.
The WHO previously granted EUL for Nuvaxovid in adults aged
18 and older in December 2021.
Trade Name in the U.S.
The trade name
Nuvaxovid™ has not yet been approved by the U.S. Food and
Drug Administration (FDA).
Important Safety Information: WHO
- 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
Nuvaxovid. 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 frequent adverse reactions in clinical trials in
individuals 12 years of age and older were headache, nausea or
vomiting myalgia, arthralgia, injection site tenderness, injection
site pain, fatigue, and malaise.
For more information on Nuvaxovid, including the Summary of
Product Characteristics with Package Leaflet, adverse event
reporting instructions, or to request additional information,
please visit the following websites:
- World Health Organization
- Novavax global authorization website
About Nuvaxovid™ (NVX-CoV2373)
Nuvaxovid (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. Nuvaxovid contains purified protein
antigen and can neither replicate, nor can it cause
COVID-19.
Nuvaxovid 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 Nuvaxovid 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 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, 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 U.S., 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 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. The Novavax COVID-19 vaccine, has
received authorization from multiple regulatory authorities
globally, including the U.S. FDA, the European Commission, and the
WHO. 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 its COVID-19-Influenza Combination (CIC)
vaccine candidate in a Phase 1/2 clinical trial, its
quadrivalent influenza investigational vaccine candidate, and
an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent
format 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.
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, NVX-CoV2515 and a
bivalent Omicron-based / original strain based vaccine, the
CIC investigational vaccine candidate, a quadrivalent
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 potential impact and reach of Novavax
and NVX-CoV2373 in addressing vaccine access, controlling the
pandemic and protecting populations, the efficacy, safety, intended
utilization, and expected administration 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
Erika Schultz |
240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler |
202-709-5563
media@novavax.com
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