- Nuvaxovid™ is now authorized in the EU for use in adults
aged 18 and older as a booster regardless of previous vaccine
history
GAITHERSBURG, Md., Sept. 12,
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 European Commission (EC) has
approved the expanded conditional marketing authorization (CMA)
of Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine in the European
Union (EU) as a homologous and heterologous booster for active
immunization to prevent coronavirus disease 2019 (COVID-19) caused
by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
for adults aged 18 and older. The approval follows the
recommendation made by the European Medicines Agency's Committee
for Medicinal Products for Human Use on September 1, 2022.
"We are pleased to offer the first protein-based vaccine as both
a primary series and booster in the European Union," said
Stanley C. Erck, President and Chief
Executive Officer, Novavax. "As we continue to explore best
practices for managing COVID-19 long term, we have ongoing trials
further exploring Nuvaxovid's efficacy and safety as a booster
and preclinical data has indicated that our vaccine induces
immune response against Omicron variants, including BA.4/5."
The expanded CMA was based on data from Novavax' Phase 2
trial conducted in Australia,
from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored
COV-BOOST trial. As part of the 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 robust antibody response when used as a
heterologous third booster dose.
In the Novavax-sponsored trials, following the booster, local
and systemic reactions were generally short-lived with 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, reflecting the increased immunogenicity
seen with a third dose. 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.
Nuvaxovid has also been authorized in Japan, Australia, and New
Zealand as a booster in adults aged 18 and older and is
actively under review in other markets.
The EC previously granted CMA for Nuvaxovid to prevent
COVID-19 in adults aged 18 and older in December 2021. Additionally, the EC granted
expanded CMA for Nuvaxovid to prevent COVID-19 in adolescents aged
12 through 17 in July 2022.
Trade Name in the U.S.
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 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:
- European Medicines Agency
- European Commission
- Novavax global authorization website
About Nuvaxovid™ (NVX-CoV2373)
Nuvaxovid 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 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 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., EC 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 its COVID-19-Influenza Combination vaccine candidate in
a Phase 1/2 clinical trial, its quadrivalent influenza
investigational vaccine candidate, and is also evaluating 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,
including an Omicron strain based vaccine and bivalent
Omicron-based / original strain based vaccine, a COVID-seasonal
influenza combination 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 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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SOURCE Novavax, Inc.