GAITHERSBURG, Md., Nov. 11,
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 removed the clinical hold on Novavax's
Investigational New Drug (IND) application for its
COVID-19-Influenza Combination (CIC) and stand-alone influenza
vaccine candidates. The FDA has cleared the Company to begin
enrolling the planned Phase 3 trial following the determination
that Novavax satisfactorily addressed all clinical hold issues.
Novavax will be working with the clinical trial investigators and
other partners to resume trial activities as quickly as
possible.
"We thank the FDA for their partnership and thorough review of
the additional information provided as part of our response
package," said Robert Walker, MD,
Chief Medical Officer, Novavax. "The information provided to the
FDA supported our assessment that the serious adverse event was not
related to our vaccine. We plan to start our Phase 3 trial as soon
as possible."
The clinical hold announced on October
16, 2024, resulted from a spontaneous report of a serious
adverse event in a participant who received investigational CIC
vaccine in a Phase 2 trial that completed in 2023. The FDA had
requested additional information on this event, initially reported
as motor neuropathy. The additional information included a change
in the event term to amytrophic lateral sclerosis, a condition that
is not known to be immune-mediated or associated with vaccination,
which in this event was assessed as not related to vaccination.
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 stand-alone influenza 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 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,
including the enrolment of trial participants;
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
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SOURCE Novavax, Inc.