GAITHERSBURG, Md., Sept. 27,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced that an initial one million doses of
Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine are now available
for use in the United Kingdom
(U.K.). Nuvaxovid is the first protein-based COVID-19 vaccine
granted authorization from the Medicines and Healthcare products
Regulatory Agency (MHRA) and will be offered per the Joint
Committee on Vaccination and Immunisation (JCVI) advice.
"With U.K. data showing that people infected with both COVID-19
and the flu are more than five times as likely to die compared to
someone with no infection1, it is more important than
ever to consider any vaccine offered to you by the National Health
Service," said Stanley C. Erck,
President and Chief Executive Officer, Novavax. "We continue to
believe in the importance of a diversified national vaccine
portfolio to reduce winter pressures on the health service."
Nuvaxovid was created using Novavax' recombinant nanoparticle
technology to generate antigen derived from the coronavirus spike
protein and is formulated with Novavax' patented saponin-based
Matrix-M™ adjuvant to enhance the immune response. Nuvaxovid
contains purified protein antigen and can neither replicate, nor
can it cause COVID-19.
The MHRA granted Conditional Marketing Authorization (CMA) for
Nuvaxovid's use as a two-dose primary series vaccine for active
immunization to prevent coronavirus disease 2019 (COVID-19) caused
by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
in adults aged 18 and older in February
2022, and in adolescents aged 12 through 17 in
August 2022. Novavax submitted a
request to the MHRA for expanded CMA of Nuvaxovid as a booster in
adults aged 18 and older on June 1,
2022 and is awaiting a decision from the agency.
▼This medicine is subject to additional monitoring. This will
allow quick identification of new safety information. If you are
concerned about an adverse event, it should be reported on a Yellow
Card. Reporting forms and information can be found at
https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA
Yellow Card in the Google Play or Apple App Store. When reporting
please include the vaccine brand and batch/Lot number if
available.
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: UK
- 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 7 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:
- MHRA Regulatory approval of COVID-19 vaccine
Nuvaxovid
- 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 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. Food and Drug Administration, 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 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, the ongoing development of NVX-CoV2373,
NVX-CoV2515 and bivalent Omicron-based / original strain based
vaccine, a COVID-seasonal influenza combination investigational
vaccine candidate, its quadrivalent influenza
investigational vaccine candidate,Novavax' plans to
supplement existing authorizations with data from the additional
manufacturing sites in Novavax' global supply
chain, the scope, timing and outcome of future regulatory
filings and actions, including potential recommendations and
authorizations from the MHRA, JCVI or any
other regulatory authority, 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; unanticipated challenges or
delays in conducting clinical trials; 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; the emergence of
variants of the SARS-CoV-2 virus that may negatively impact market
acceptance or anticipated sales of NVX-CoV-2373; 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 statement. 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 statement 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.
References
- Stowe J, et al. Interactions between SARS-CoV-2 and influenza
and the impact of coinfection on disease severity: a test-negative
design. International Journal of Epidemiology. 2021 Aug
30;50(4):1124-1133.
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.