GAITHERSBURG, Md., Nov. 9, 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
Medicines and Healthcare products Regulatory Agency (MHRA) in the
United Kingdom (U.K.) has expanded
the conditional marketing authorization (CMA)i for
Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine▼ as a homologous and
heterologous booster dose after the primary series of Nuvaxovid
(six months) or of an mRNA or adenoviral vector 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.
"Our protein-based vaccine, developed using an innovative
approach to traditional technology, may have a prominent role to
play in COVID-19 boosting," 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 immunogenicity
as a booster dose. Currently available clinical and preclinical
data indicate that our vaccine induces robust immune responses
against Omicron variants, including BA.4/5."
The MHRA decision was based on data from Novavax' Phase 2 trial
conducted in the U.S. and Australia (1,283 participants), from a
separate Phase 2 trial conducted in South Africa (4,404 participants), and from
the U.K.-sponsored COV-BOOST trial (2,878
participants).1,2 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.1,2 The third dose
produced increased immune responses against the original ancestral
strain of SARS-CoV-2 comparable to or exceeding levels associated
with protection in Phase 3 clinical trials.1,2 In the
COV-BOOST trial, Nuvaxovid increased antibody titers when used as a
heterologous third booster dose after a primary two-dose
vaccination series of an mRNA vaccine or adenoviral vector
vaccine.2
In the Novavax-sponsored trials, following the booster, local
and systemic reactions had a median duration of approximately two
days.1,2 Adverse reactions were usually mild to moderate
in severity.1,2 Safety reporting of reactogenicity
events showed an increasing incidence across all three doses of
Nuvaxovid. 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.1,2
Nuvaxovid is also available for use as a booster in adults aged
18 and older in the U.S., European Union, Japan, Australia, New
Zealand, Switzerland, and
Israel. In addition, a number of
countries have policy recommendations allowing use of the vaccine
as a heterologous or homologous booster dose.
The MHRA previously granted CMA for Nuvaxovid as a primary
series in adults aged 18 and older in February 2022, and in adolescents aged 12
through 17 in August 2022.
▼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 yet been approved by the U.S. Food and
Drug Administration (FDA).
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 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)
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 populations and
indications 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, its partnerships, the potential for subsequent
orders from the U.S. government for additional doses of NVX-CoV2373
and other potential formulations, the timing of clinical trial
results, the ongoing development of NVX-CoV2373, including
NVX-CoV2515 and bivalent Omicron-based / original strain based
vaccine, a COVID-seasonal influenza investigational vaccine
candidate, its quadrivalent influenza investigational
vaccine candidate, the scope, timing and outcome of future
regulatory filings and actions, including any potential
recommendations and authorizations from JVCI,
MHRA or any other regulatory authority, 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 and intended utilization 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; 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; 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
References
- Mallory RM, Formica N, Pfeiffer S, et al. Safety and
immunogenicity following a homologous booster dose of a SARS-CoV-2
recombinant spike protein vaccine (NVX-CoV2373): a secondary
analysis of a randomised, placebo-controlled, phase 2 trial
[published online ahead of print, 2022 Aug 10]. Lancet Infect
Dis. 2022;S1473-3099(22)00420-0.
doi:10.1016/S1473-3099(22)00420-0.
- Munro APS, Janani L, Cornelius V, et al. Safety and
immunogenicity of seven COVID-19 vaccines as a third dose (booster)
following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK
(COV-BOOST): a blinded, multicentre, randomised, controlled, phase
2 trial [published correction appears in Lancet. 2021 Dec
18;398(10318):2246]. Lancet. 2021;398(10318):2258-2276.
doi:10.1016/S0140-6736(21)02717-3.
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SOURCE Novavax, Inc.