GAITHERSBURG, Md., Oct. 16,
2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a global company advancing protein-based vaccines with its
Matrix-M™ adjuvant, today announced that the U.S. Food and Drug
Administration (FDA) has placed a clinical hold on Novavax's
Investigational New Drug (IND) application for its
COVID-19-Influenza Combination (CIC) and stand-alone influenza
vaccine candidates. The clinical hold is due to a spontaneous
report of a serious adverse event (SAE) of motor neuropathy in a
single CIC Phase 2 trial participant outside of the U.S. who
received the vaccine in January 2023.
The trial completed in July 2023 and
the participant reported the SAE in September 2024.
"We are working closely with the FDA to provide the necessary
information that will allow them to better understand this
observation and resolve the clinical hold," said Robert Walker, MD, Chief Medical Officer,
Novavax. "It is important to note that safety is our top priority,
and while we do not believe causality has been established for this
serious adverse event, we are committed to working expeditiously to
fulfill requests for more information from the FDA. Our goal is to
successfully resolve this matter and to start our Phase 3 trial as
soon as possible."
Data from Novavax's previous COVID-19 and influenza trials have
shown no signals for motor neuropathy. Investigators have been
informed of this action. The COVID-19 IND for Novavax's
COVID-19 vaccine is not impacted by the clinical hold.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by
discovering, developing and commercializing innovative vaccines to
help protect against serious infectious diseases. Novavax, a global
company based in Gaithersburg,
Md., U.S., offers a differentiated vaccine platform that
combines a recombinant protein approach, innovative nanoparticle
technology and Novavax's patented Matrix-M adjuvant to enhance the
immune response. The Company's portfolio includes its COVID-19
vaccine and its pipeline includes its CIC and tNIV vaccine
candidates. In addition, Novavax's adjuvant is included in the
University of Oxford and Serum
Institute of India's R21/Matrix-M
malaria vaccine. Please visit novavax.com and
LinkedIn for more information.
Forward-Looking Statements
Statements herein relating
to the potential resolution of the clinical hold placed
on Novavax's IND for its CIC and stand-alone influenza vaccine
candidates and the timing of the initiation of the Phase 3 trial
for Novavax's CIC and stand-alone influenza vaccine candidates 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; resource constraints, including
human capital and manufacturing capacity, on the ability of Novavax
to pursue planned regulatory pathways; challenges or delays in
clinical trials; manufacturing, distribution or export delays or
challenges; Novavax's exclusive dependence on Serum Institute of
India Pvt. Ltd. for co-formulation and filling and the impact of
any delays or disruptions in their operations on the delivery of
customer orders; 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's Annual Report on Form 10-K for the year ended
December 31, 2023, 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
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
240-720-7804
media@novavax.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/update-on-novavaxs-covid-19-influenza-combination-and-stand-alone-influenza-phase-3-trial-302277807.html
SOURCE Novavax, Inc.