Initial Results from Novavax' COVID-19-Influenza Vaccine Trial are First to Show Feasibility of Combination Vaccine
PR95566
GAITHERSBURG, Md., April 21, 2022 /PRNewswire=KYODO JBN/ --
-- Phase 1/2 clinical trial of COVID-19-Influenza combination vaccine
candidate indicates vaccine is well-tolerated and immunogenic
-- Data from this combination trial will inform planned Phase 2 dose
confirmation trial, scheduled to begin by the end of 2022
-- Immune response confirmed in stand-alone influenza vaccine and
combination vaccine with potential path forward for both
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced initial results from the Phase 1/2 clinical trial of its
COVID-Influenza Combination Vaccine (CIC). The CIC combines Novavax' COVID-19
vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate. The CIC
trial demonstrated that formulating the combination vaccine is feasible,
well-tolerated and immunogenic.
"We continue to evaluate the dynamic public health landscape and believe there
may be a need for recurrent boosters to fight both COVID-19 and seasonal
influenza," said Gregory M. Glenn, M.D., President of Research and Development,
Novavax. "We're encouraged by these data and the potential path forward for a
combination COVID-19-influenza vaccine as well as stand-alone vaccines for
influenza and COVID-19."
The safety and tolerability profile of the combination vaccine was consistent
with the stand-alone NVX-CoV2373 and quadrivalent nanoparticle influenza
vaccine reference formulations in the trial. The combination vaccine was found
to be generally well tolerated. Serious adverse were rare and none were
assessed as being related to the vaccine.
The study employed descriptive endpoints, assessing safety and the
immunological responses of different CIC vaccine formulations. A Design of
Experiments (DOE) modeling-based approach was used to design the trial,
enabling more powerful fine-tuning of dose selection of both the COVID-19 and
influenza antigens for further development compared to traditional approaches.
The preliminary trial results found that various CIC vaccine formulations
induced immune responses in participants comparable to reference stand-alone
influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2,
B-Victoria HA and SARS-CoV-2 rS antigens). Modeling results also showed that a
combined formulation has the potential to reduce total antigen amount by up to
50% overall, optimizing production and delivery.
Both protein-based vaccines used in the trial were formulated with the patented
saponin-based Matrix-M(TM) adjuvant to enhance the immune response and
stimulate high levels of neutralizing antibodies. These data support
advancement to a Phase 2 confirmation trial, expected to begin by the end of
2022.
Data from the trial were presented at the World Vaccine Congress (WVC) in
Washington, DC.
Influenza Program Update
At the WVC, Novavax also reviewed key findings from the Phase 3 trial of its
stand-alone influenza candidate, previously referred to as NanoFlu, which met
its primary immunogenicity endpoint. These results have previously been
published in The Lancet (https://c212.net/c/link/?t=0&l=en&o=3510692-1&h=3626900746&u=https%3A%2F%2Fwww.thelancet.com%2Fjournals%2Flaninf%2Farticle%2FPIIS1473-3099(21)00192-4%2Ffulltext&a=The+Lancet).
Authorization in the U.S.
Neither NVX-CoV2373 or the influenza vaccine candidate have been authorized or
approved for use in the U.S. by the U.S. Food and Drug Administration.
Important Safety Information for NVX-CoV2373
-- NVX-CoV2373 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 NVX-CoV2373.
-- 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.
-- NVX-CoV2373 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 NVX-CoV2373 may be lower in immunosuppressed individuals.
-- Administration of NVX-CoV2373 in pregnancy should only be considered
when the potential benefits outweigh any potential risks for the mother
and foetus.
-- The effects with NVX-CoV2373 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 NVX-CoV2373 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 additional safety information, including the full Summary of Product
Characteristics with Package Leaflet, please visit www.NovavaxCovidVaccine.com.
About the COVID-19-Influenza Combination Vaccine Phase 1/2 trial
The Phase 1/2 CIC vaccine trial is evaluating a combination of Novavax'
recombinant protein-based NVX-CoV2373 and influenza vaccine candidates and
patented saponin-based Matrix-M adjuvant in a single formulation. The trial
will evaluate the safety, tolerability and immune response to the combination
vaccine in 642 healthy adults 50 to 70 years of age. Participants will have
been either previously infected with the SARS-CoV-2 virus that causes COVID-19
or vaccinated through an authorized vaccine at least eight weeks prior to
enrollment. All participants will be randomly assigned to cohorts to evaluate
multiple formulations and will be dosed on Day 0 and again at Day 56. The trial
is being conducted in Australia at 10 sites. (ClinicalTrials.gov Identifier:
NCT04961541)
About NVX-CoV2373
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.
NVX-CoV2373 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.
NVX-CoV2373 contains purified protein antigen and can neither replicate, nor
can it cause COVID-19.
Novavax' COVID-19 vaccine 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 degrees – 8 degrees 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 NVX-CoV2373 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 Matrix-M(TM) 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' Influenza Program
Novavax' influenza vaccine, previously known as NanoFlu, is a quadrivalent
recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced
by Novavax in its SF9 insect cell baculovirus system. The influenza vaccine
uses HA amino acid protein sequences that are the same as the recommended
wild-type circulating virus HA sequences, and contains Novavax' patented
saponin-based Matrix-M adjuvant. This investigational candidate was evaluated
during a controlled phase 3 trial conducted during the 2019-2020 influenza
season.
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. NVX-CoV2373, the company's
COVID-19 vaccine, has received conditional authorization from multiple
regulatory authorities globally, including the European Commission and the
World Health Organization. The vaccine is also under review by multiple
regulatory agencies worldwide.
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, including
the Phase 2 confirmation trial expected to begin by the end of 2022, the
ongoing development of NVX-CoV2373, NanoFlu, its COVID-seasonal influenza
investigational vaccine candidate, and its COVID-Influenza Combination Vaccine,
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, the potential impact and reach of
Novavax and its COVID-19 Influenza Combination Vaccine in protecting
populations, and the efficacy, safety and intended utilization of the COVID-19
Influenza Combination Vaccine, NanoFlu, and 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; 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, 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 | +1 240-268-2022
ir@novavax.com
Media
Ali Chartan | +1 240-720-7804
Laura Keenan Lindsey | +1 202-709-7521
media@novavax.com
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SOURCE Novavax, Inc.
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