ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence
and clinical research organisation, today announces that it is
partnering with the U.S. Biomedical Advanced Research and
Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response within the U.S. Department of
Health and Human Services, to execute a clinical trial to evaluate
the effectiveness of next generation COVID-19 vaccine
candidates.
Next generation COVID-19 vaccines could have the potential to
expand the breadth of coverage against existing and future variants
of the virus, extend the duration of protection, and offer better
protection in the prevention of illness and transmission over the
current state of vaccine technologies. Against this backdrop, the
Government & Public Health Solutions team at ICON will execute
a Phase 2b clinical trial to assess the relative efficacy of a next
generation COVID-19 vaccine compared to currently
approved/authorised COVID-19 vaccines in the prevention of
symptomatic, PCR confirmed SARS-CoV-2 infection.
The trial will involve 10,000 subjects, expected to be enrolled
over a six-month period. BARDA will select the vaccine candidate to
be investigated in this trial, thereby accelerating the start of
the Phase 2b clinical trial to support in benchmarking its efficacy
against existing vaccines.
ICON has extensive experience in vaccine clinical development
for commercial businesses, governments and NGOs, having
participated in over 184 vaccine studies in the past five years.
This experience has already helped ICON play a significant role in
the search for vaccines and treatments for COVID-19. The company
has partnered with its customers on the development of a number of
approved vaccines. ICON has conducted or is currently involved in
over 86 COVID-19 related trials.
Edward Wright, President, ICON Government & Public Health
Solutions, commented: “We are pleased to be partnering with BARDA
on this research at an important juncture in the fight against
COVID-19. As new variants emerge, timely clinical research has a
pivotal role to play in helping ensure the development of medicines
is accelerating as quickly as possible in line with the virus. Our
experience in executing COVID-19 trials effectively, efficiently
and thoroughly means we are well placed to support those sponsors
who are at the scientific forefront in this area.”
In addition to its Government & Public Health Solutions
team, ICON draws on the expertise of its biotech division, which
comprises over 8,000 staff dedicated to biotech customers. As the
world’s largest dedicated biotech division, the team works with
over 500 biotech sponsors annually.
Chris Smyth, President, ICON Biotech Solutions commented: “In
addition to our vaccine clinical development experience, we
understand the important role biotech companies have in innovative
drug development, and the specific requirements they have as they
look to develop their portfolios. We are pleased to have the
opportunity to work with them on this trial.”
This trial is part of Project NextGen, which coordinates across
the U.S. Government and the private sector to advance innovative
vaccines and therapeutics into clinical trials, regulatory review,
and potential commercial availability.
BARDA is responsible for developing medical countermeasures to
secure the U.S. against chemical, biological, radiological, and
nuclear threats, as well as pandemic influenza and emerging
infectious diseases.
Since 2014, ICON has been a member of BARDA’s Medical
Countermeasures Clinical Studies Network (CSN). The network
supports planning and implementation of clinical studies for
medical countermeasure development. ICON has worked on numerous
clinical trials as part of this network, including, most recently,
the execution of an anthrax vaccine clinical trial.
This project has been supported in whole or in part with federal
funds from the Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA), under contract
number 75A50120D00017.
Ends
About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical
research organisation. From molecule to medicine, we advance
clinical research providing outsourced services to pharmaceutical,
biotechnology, medical device and government and public health
organisations. We develop new innovations, drive emerging therapies
forward and improve patient lives. With headquarters in Dublin,
Ireland, ICON employed approximately 41,160 employees in 108
locations in 53 countries as at June 30, 2023. For further
information about ICON, visit: www.iconplc.com.
This press release contains forward-looking statements. These
statements are based on management's current expectations and
information currently available, including current economic and
industry conditions. These statements are not guarantees of future
performance or actual results, and actual results, developments and
business decisions may differ from those stated in this press
release. The forward-looking statements are subject to future
events, risks, uncertainties and other factors that could cause
actual results to differ materially from those projected in the
statements, including, but not limited to, the ability to enter
into new contracts, maintain client relationships, manage the
opening of new offices and offering of new services, the
integration of new business mergers and acquisitions, the impact of
COVID-19 on our business, as well as other economic and global
market conditions and other risks and uncertainties detailed from
time to time in SEC reports filed by ICON, all of which are
difficult to predict and some of which are beyond our control. For
these reasons, you should not place undue reliance on these
forward-looking statements when making investment decisions. The
word "expected" and variations of such words and similar
expressions are intended to identify forward-looking statements.
Forward-looking statements are only as of the date they are made
and we do not undertake any obligation to update publicly any
forward-looking statement, either as a result of new information,
future events or otherwise. More information about the risks and
uncertainties relating to these forward-looking statements may be
found in SEC reports filed by ICON, including its Form 20-F, F-1,
F-4, S-8, F-3 and certain other reports, which are available on the
SEC's website at http://www.sec.gov.
About ICON Government & Public Health Solutions
ICON Government & Public Health Solutions (GPHS) is ICON's
business unit focused on direct U.S. Government engagement,
Non-Government Organisations (NGOs) and academia, providing full
service and functional research solutions. In addition, ICON GPHS
coordinates a Government Centre of Excellence (CoE) to lend
internal federal government subject matter expertise that can be
leveraged by other ICON business units when commercial clients
receive federal funding on ICON awarded contracts.
About BARDA’s Medical Countermeasures Clinical Studies
Network (CSN)
The CSN provides BARDA partners and medical countermeasure
developers with essential tools and services to develop vaccines,
therapeutics, diagnostics, and medical devices. The CSN provides
comprehensive (Phases 1-4) clinical study services to help evaluate
the safety, dosage, pharmacokinetics/pharmacodynamics,
immunogenicity, and efficacy of medical countermeasure candidates,
provide long-term storage services for clinical and nonclinical
biological specimens and investigational products for future
assays, and provide a statistical and data coordinating centre for
harmonisation across BARDA projects.
ICON/ICLR-G
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Media Contacts: Claire Quinn (GMT time zone) Corporate
Communications, ICON plc +353 87 4066091 claire.quinn@iconplc.com
Weber Shandwick (PR adviser) Lisa Henry (GMT time zone)
lhenry@webershandwick.com +44 7785 458203
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