First participants dosed in Phase 3 trial (ENSEMBLE)
evaluating safety and efficacy of Janssen's COVID-19 vaccine
candidate, JNJ-78436735, also known as Ad26.COV2.S
NEW BRUNSWICK, New Jersey,
Sept. 23, 2020 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced the launch of its large-scale, pivotal, multi-country
Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate,
JNJ-78436735, being developed by its Janssen Pharmaceutical
Companies. The initiation of the ENSEMBLE trial follows positive
interim results from the Company's Phase 1/2a clinical study, which
demonstrated that the safety profile and immunogenicity after a
single vaccination were supportive of further development. These
results have been submitted to medRxiv and are due to be published online
imminently. Based on these results and following discussions
with the U.S. Food and Drug Administration (FDA), ENSEMBLE will
enroll up to 60,000 volunteers across three continents and will
study the safety and efficacy of a single vaccine dose versus
placebo in preventing COVID-19.
Johnson & Johnson has continued the scaling up of its
manufacturing capacity and remains on track to meet its goal of
providing one billion doses of a vaccine each year. The Company is
committed to bringing an affordable vaccine to the public on a
not-for-profit basis for emergency pandemic use and anticipates the
first batches of a COVID-19 vaccine to be available for emergency
use authorization in early 2021, if proven to be safe and
effective.
Johnson & Johnson will develop and test its COVID-19 vaccine
candidate in accordance with high ethical standards and sound
scientific principles. The Company is committed to transparency and
sharing information related to the Phase 3 ENSEMBLE study –
including the study protocol.
"As COVID-19 continues to impact the daily lives of people
around the world, our goal remains the same – leveraging the global
reach and scientific innovation of our company to help bring an end
to this pandemic," said Alex Gorsky,
Chairman and Chief Executive Officer, Johnson & Johnson. "As
the world's largest healthcare company, we are bringing to bear our
best scientific minds, and rigorous standards of safety, in
collaboration with regulators, to accelerate the fight against this
pandemic. This pivotal milestone demonstrates our focused
efforts toward a COVID-19 vaccine that are built on
collaboration and deep commitment to a robust scientific
process. We are committed to clinical trial transparency
and to sharing information related to our study, including details
of our study protocol."
"We remain fully focused on developing an urgently needed, safe
and effective COVID-19 vaccine for people around the world," said
Paul Stoffels, M.D., Vice Chairman
of the Executive Committee and Chief Scientific Officer, Johnson
& Johnson. "We greatly value the collaboration and support
from our scientific partners and global health authorities as our
global team of experts work tirelessly on the development of the
vaccine and scaling up our production capacity with a goal to
deliver a vaccine for emergency use authorization in early
2021."
The Janssen COVID-19 vaccine candidate leverages the Company's
AdVac® technology platform, which was also used
to develop and manufacture Janssen's European Commission
approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine
candidates. Janssen's AdVac® technology platform has
been used to vaccinate more than 100,000 people to date across
Janssen's investigational vaccine programs.
With Janssen's AdVac® technology, the vaccine,
if successful, is estimated at launch to remain stable for two
years at -20 °C and at least three months at 2-8° C. This makes the
vaccine candidate compatible with standard vaccine distribution
channels and would not require new infrastructure to get it to the
people who need it.
PHASE 3 ENSEMBLE STUDY
The Phase 3 ENSEMBLE study is a randomized, double-blind,
placebo-controlled clinical trial designed to evaluate the safety
and efficacy of a single vaccine dose versus placebo in up to
60,000 adults 18 years old and older, including significant
representation from those that are over age 60. The trial will
include those both with and without comorbidities associated with
an increased risk for progression to severe COVID-19, and will aim
to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru,
South Africa and the United States. In order to evaluate the
effectiveness of Janssen's COVID-19 vaccine, countries and clinical
trial sites which have a high incidence of COVID-19 and the ability
to achieve a rapid initiation will be activated.
Built on a legacy of purpose-driven actions and a commitment to
diversity and inclusion, the Company aims to achieve representation
of populations that have been disproportionately impacted by the
pandemic in the implementation of its COVID-19 Phase 3 trial
program. In the U.S., this includes significant representation of
Black, Hispanic/Latinx, American Indian and Alaskan Native
participants.
ENSEMBLE is being initiated in collaboration with the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response at
the U.S. Department of Health and Human Services (HHS) under Other
Transaction Agreement HHSO100201700018C, and the National Institute
of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH) at HHS.
In parallel, the Company has also agreed in principle to
collaborate with the United
Kingdom of Great Britain
and Northern Ireland (the UK
Government) on a separate Phase 3 clinical trial in multiple
countries to explore a two-dose regimen of Janssen's vaccine
candidate.
"With our vaccine candidate now in our global Phase 3 trial, we
are one step closer to finding a solution for COVID-19. We used a
highly scientific and evidence-based approach to select this
vaccine candidate. We are extremely grateful for the tireless
efforts of our researchers and for the vital contributions of those
participants who have volunteered to take part in our studies.
Together, we are working to help combat this pandemic," said
Mathai Mammen, M.D., Ph.D., Global
Head, Janssen Research & Development, LLC, Johnson &
Johnson.
The Company is in ongoing discussions with many stakeholders,
including national governments and global organizations, as part of
its efforts to meet its commitment to make the vaccine candidate
accessible globally, provided the vaccine is demonstrated to be
safe and effective and following regulatory approval.
For more information on Johnson & Johnson's multi-pronged
approach to helping combat the pandemic, visit:
www.jnj.com/coronavirus.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation
of vibrant lives, thriving communities and forward progress. That's
why for more than 130 years, we have aimed to keep people well at
every age and every stage of life. Today, as the world's largest
and most broadly-based healthcare company, we are committed to
using our reach and size for good. We strive to improve access and
affordability, create healthier communities, and put a healthy
mind, body and environment within reach of everyone, everywhere. We
are blending our heart, science and ingenuity to profoundly change
the trajectory of health for humanity. Learn more at www.jnj.com.
Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies
At
Janssen, we're creating a future where disease is a thing of the
past. We're the Pharmaceutical Companies of Johnson & Johnson,
working tirelessly to make that future a reality for patients
everywhere by fighting sickness with science, improving access with
ingenuity, and healing hopelessness with heart. We focus on areas
of medicine where we can make the biggest difference:
Cardiovascular & Metabolism, Immunology, Infectious Diseases
& Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at @JanssenGlobal.
Notice to Investors Concerning Forward-Looking
Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding development of a potential preventive vaccine for
COVID-19. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of the Janssen Pharmaceutical Companies, and/or Johnson
& Johnson. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 29, 2019, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in the company's most
recently filed Quarterly Report on Form 10-Q, and the company's
subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. None of the
Janssen Pharmaceutical Companies nor Johnson & Johnson
undertakes to update any forward-looking statement as a result of
new information or future events or developments.
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