- U.S. NIAID-sponsored trial will evaluate heterologous
booster regimens, including NVX-CoV2373, after primary series with
current FDA approved or emergency use authorized-vaccines
- NVX-CoV2373 will be evaluated in a head-to-head boosting
trial in the United Arab Emirates
to assess boosting options for a large number of the world's
population that have previously been vaccinated with inactivated
COVID-19 vaccine
GAITHERSBURG, Md., March 25, 2022 /PRNewswire/ -- Novavax, Inc.
(Nasdaq: NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases, today announced that NVX-CoV2373, its protein-based
COVID-19 vaccine, is included in two trials now underway to
evaluate its vaccine's safety, immunogenicity, and reactogenicity
as a booster amidst the ongoing COVID-19 pandemic. Both studies
have initiated participant enrollment and will help to extend
knowledge of how a range of vaccines, including Novavax' COVID-19
vaccine, can be used as boosters following primary
immunization.
"Additional COVID-19 booster studies are important to support
vaccine choice for individuals, healthcare providers, and public
health authorities," said Filip
Dubovsky, M.D., Chief Medical Officer, Novavax. "Our
COVID-19 vaccine has already been recommended by multiple national
policy bodies for both primary vaccination and booster settings in
individuals 18 years of age and older. We look forward to adding to
this body of evidence to support the expanded use of our
protein-based vaccine."
Novavax is participating in an ongoing Phase 1/2 trial sponsored
by the National Institute of Allergy and Infectious Diseases
(NIAID) to assess homologous and heterologous boosting regimens in
participants who received a primary series of a COVID-19 vaccine
which has received full approval or Emergency Use Authorization
(EUA) from the U.S. Food and Drug Administration (FDA).
Participants will be given a third dose (> 12 weeks later) of
either NVX-CoV2373 or one of the three COVID-19 vaccines that have
already received EUA or full authorization from the FDA. The study
is enrolling approximately 1,130 healthy individuals aged 18 years
or older, about 180 of whom will receive NVX-CoV2373 as a
heterologous booster. The trial is being conducted at approximately
10 clinical research sites and its primary objectives are to
evaluate safety, reactogenicity, and immunogenicity of delayed
heterologous or homologous vaccine doses after EUA dosed vaccines.
Participants will be followed for 12 months, with topline results
expected later this year and full results expected in 2023.
Novavax' COVID-19 vaccine is also being evaluated in an
observer-blinded Phase 3 study in the United Arab Emirates (UAE) to assess
homologous versus heterologous boosting of participants who have
already been immunized with Sinopharm's COVID-19 vaccine. The
safety and immunogenicity of a single booster dose of Novavax'
COVID-19 vaccine in adults previously vaccinated with Sinopharm's
COVID-19 vaccine will be evaluated. The study is enrolling
approximately 1,000 participants aged 18 years or older at two
centers in Abu Dhabi with the goal
of providing data to support boosting with NVX-CoV2373 in the large
number of individuals who have been vaccinated with inactivated
vaccines globally. Participants will be followed for six months,
with full results expected during the fourth quarter of 2022. The
Ministry of Health and Prevention approved NVX-CoV2373 for
emergency use in the UAE in December.
For more information about the NIAID-sponsored study,
read here on clinicaltrials.gov. For more
information about the study in the UAE, read here
on clinicaltrials.gov. NVX-CoV2373 has not yet been authorized
for use by the FDA, nor has it received heterologous or homologous
booster approval in all the countries where it's been
authorized.
Important Safety Information
- 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.
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
(SII), 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 NVX-CoV2373 Phase 3
trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3
trials.
PREVENT-19, a trial in the U.S. and Mexico that
enrolled almost 30,000 participants aged 18 years and older,
achieved 90.4% efficacy overall. It was designed as a 2:1
randomized, placebo-controlled, observer-blinded study to evaluate
the efficacy, safety and immunogenicity of NVX-CoV2373. The primary
endpoint for PREVENT-19 was the first occurrence of PCR-confirmed
symptomatic (mild, moderate or severe) COVID-19 with onset at least
7 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. 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).
A trial conducted in the U.K. with 14,039 participants aged 18
years and older 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
7 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. 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. In
addition to its COVID-19 vaccine, Novavax is also currently
evaluating a COVID-seasonal influenza combination vaccine in a
Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu,
its quadrivalent influenza investigational vaccine candidate. 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 Twitter, LinkedIn, Instagram and Facebook.
Forward-Looking
Statements
Statements herein relating to the future of Novavax, its
operating plans and prospects, its partnerships, the timing of
clinical trial results, the ongoing development of NVX-CoV2373 and
NanoFlu, its COVID-seasonal influenza investigational vaccine
candidate, 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, the potential impact and
reach of Novavax and NVX-CoV2373 in addressing vaccine access,
controlling the pandemic and protecting populations, and the
efficacy, safety and intended utilization 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; 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
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey |
202-709-7521
media@novavax.com
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