- 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
GAITHERSBURG, Md., April 20, 2022 /PRNewswire/
-- 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™ 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.
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°- 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 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™ 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 | 240-268-2022
ir@novavax.com
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey |
202-709-7521
media@novavax.com
Logo -
https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg