- Full authorization of prototype enables rapid authorization
of updated Novavax COVID-19 vaccines in future
GAITHERSBURG, Md., Oct. 18,
2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a global company advancing protein-based vaccines with its
Matrix-M™ adjuvant, today announced that the Medicines and
Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has granted full
marketing authorization for its prototype COVID-19 vaccine
Nuvaxovid™ ▼ (NVX-CoV2373) for individuals aged 12 and older for
active immunization to help prevent COVID-19.
"Full marketing authorization of our prototype COVID-19 vaccine
in the U.K. is a stepping stone to enable authorization of updated
strains of our vaccine in the future," said John C. Jacobs, President and Chief Executive
Officer, Novavax. "We are working with the MHRA to provide the
information needed for the rapid review of our updated
protein-based non-mRNA COVID-19 vaccine as an important step to
ensuring access to vaccine options in the U.K. this coming
vaccination season."
Authorization was based on two Phase 3 trials, PREVENT-19
conducted in the U.S. and Mexico
and a Phase 3 trial in the U.K., as well as a Phase 2a/b trial in
South Africa. In these trials,
Novavax demonstrated the efficacy and safety of its prototype
vaccine as a primary series in individuals aged 12 and older, and
the immunogenicity and safety of the vaccine as a booster in
individuals aged 18 and older.
▼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.
|
i. Additional efficacy
and safety data are being collected.
|
Trade Name in the U.S.
The trade name Nuvaxovid™
has not been approved by the U.S. Food and
Drug Administration.
Important Safety Information: U.K.
- 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 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.
- There is an increased risk of myocarditis and pericarditis
following vaccination with Nuvaxovid. These conditions can develop
within just a few days after vaccination and have primarily
occurred within 14 days. Available data suggest that the course of
myocarditis and pericarditis following vaccination is not different
from myocarditis or pericarditis in general. Healthcare
professionals should be alert to the signs and symptoms of
myocarditis and pericarditis. Vaccinees (including parents or
caregivers) should be instructed to seek immediate medical
attention if they develop symptoms indicative of myocarditis or
pericarditis such as (acute and persisting) chest pain, shortness
of breath, or palpitations following vaccination. Healthcare
professionals should consult guidance and/or specialists to
diagnose and treat this condition.
- 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 (adverse reactions described in section 4.8 of the
SPC) 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)
NVX-CoV2373 is a
protein-based vaccine made by creating copies of the surface spike
protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique
recombinant nanoparticle technology, the non-infectious spike
protein serves as the antigen that primes the immune system to
recognize the virus, while Novavax's Matrix-M adjuvant enhances and
broadens the immune response. The vaccine is packaged as a
ready-to-use liquid formulation and is stored at 2° to 8°C,
enabling the use of existing vaccine supply and cold chain
channels.
About the PREVENT-19 Phase 3 Trial
The PRE-fusion
protein subunit Vaccine Efficacy Novavax Trial
COVID-19 (PREVENT-19) was a randomized, placebo-controlled,
observer-blinded Phase 3 trial conducted in the U.S. and
Mexico to evaluate the efficacy
and safety of NVX-CoV2373 as a primary series and as a booster in
adults and adolescents to prevent SARS-CoV-2 infection. As a
primary series, the primary endpoint was the first occurrence of
polymerase chain reaction (PCR)-confirmed symptomatic (mild,
moderate, or severe) COVID-19 with onset at least seven days after
the second dose in 29,960 adult participants aged 18 and older at
baseline without protocol violations prior to illness. A secondary
endpoint was the prevention of PCR-confirmed, symptomatic moderate
or severe COVID-19. Full results of the trial were published in
the New England Journal of Medicine.
About the NVX-CoV2373 U.K. Phase 3 Trial
The
primary endpoint in this phase 3, randomized, observer-blinded,
placebo-controlled trial conducted in the United Kingdom
(U.K.), was first occurrence of confirmed
COVID-19 with onset at least seven days after the second
vaccination. The trial enrolled 14,039 adult participants aged 18
and older. Full results were published in the New England
Journal of Medicine.
About Matrix-M™ Adjuvant
When added to vaccines,
Novavax's patented saponin-based Matrix-M adjuvant enhances the
immune system response, making it broader and more durable. The
Matrix-M adjuvant stimulates the entry of antigen-presenting cells
at the injection site and enhances antigen presentation in local
lymph nodes.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by
discovering, developing and commercializing innovative vaccines to
help protect against serious infectious diseases. Novavax, a
global company based in Gaithersburg, Md., U.S., offers a
differentiated vaccine platform that combines a recombinant protein
approach, innovative nanoparticle technology
and Novavax's patented Matrix-M adjuvant to
enhance the immune response. Focused on the world's most urgent
health challenges, Novavax is currently evaluating
vaccines for COVID-19, influenza and COVID-19 and influenza
combined. Please
visit novavax.com and LinkedIn for more
information.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and
prospects, the scope, timing and outcome of future regulatory
filings and actions. 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 or delays in obtaining regulatory authorization for its
product candidates, including future COVID-19 variant strain
changes; challenges or delays in clinical trials; manufacturing,
distribution or export delays or challenges; 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's Annual Report on Form
10-K for the year ended December 31, 2022 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
240-720-7804
media@novavax.com
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SOURCE NOVAVAX, INC