GAITHERSBURG, Md., Aug. 4, 2022
/PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology
company dedicated to developing and commercializing next-generation
vaccines for serious infectious diseases, today announced the
initiation of its Phase 2b/3
Hummingbird™ global clinical trial. The trial will evaluate the
safety, effectiveness (immunogenicity), and efficacy of two doses
of the Novavax COVID-19 vaccine (NVX-CoV2373) in younger children
aged six months through 11 years, followed by a booster at six
months after the primary vaccination series.
"We are excited to begin the Hummingbird trial to study
Nuvaxovid's efficacy in children as young as six months through age
11," said Stanley C. Erck, President
and Chief Executive Officer, Novavax. "With a successful trial, we
may have the opportunity to offer our COVID-19 vaccine to all age
groups aged six months and older for protection against this
ongoing pandemic."
The trial will assess the Novavax COVID-19 vaccine in infants
(six through 23 months of age), toddlers (two through five years)
and children (six through 11 years). The trial is an age
de-escalation trial and age groups will be tested sequentially.
Participants have begun dosing in the six to 11-year-old age group.
The trial will also have sentinel cohorts in each age group and
cohort progression and age-de-escalation will occur after safety
review.
The trial will seek to enroll 3,600 participants in the US,
Mexico, Colombia, Argentina, Spain, UK, South
Africa, Philippines, and
Brazil. Initial results are
expected in Q1 2023.
About the Novavax COVID-19 vaccine (NVX-CoV2373)
The Novavax COVID-19 vaccine (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. The Novavax COVID-19 vaccine contains
purified protein antigen and can neither replicate, nor can it
cause COVID-19.
The 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 its COVID-19 vaccine
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
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., EC and the
WHO. The vaccine is currently under review by multiple regulatory
agencies worldwide, including for additional indications and
populations such as adolescents and as a booster. In addition to
its COVID-19 vaccine, Novavax is also currently evaluating a
COVID-seasonal influenza combination vaccine candidate in a Phase
1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu*, its
quadrivalent influenza investigational vaccine candidate, and is
also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as
well as a bivalent 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.
*NanoFlu identifies a recombinant hemagglutinin (HA) protein
nanoparticle influenza vaccine candidate produced by Novavax. This
investigational candidate was evaluated during a controlled phase 3
trial conducted during the 2019-2020 influenza season.
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,
including an Omicron strain based vaccine and bivalent
Omicron-based / original strain based vaccine, a COVID-seasonal
influenza investigational combination 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, additional worldwide authorizations of NVX-CoV2373
for use in adults and adolescents, and as a booster, the evolving
COVID-19 pandemic, 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; 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; unanticipated challenges or
delays in conducting clinical trials; 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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/novavax-announces-initiation-of-phase-2b3-hummingbird-global-clinical-trial-for-the-novavax-covid-19-vaccine-in-children-aged-six-months-through-11-years-301600069.html
SOURCE Novavax, Inc.