Company working to ensure broad global
access to COVID-19 vaccine candidate,
following approval from regulators
NEW BRUNSWICK, N.J., Aug. 5,
2020 /CNW/ -- Johnson & Johnson (NYSE: JNJ) (the
Company) today announced its Janssen Pharmaceutical Companies have
entered into an agreement with the U.S. government for the large
scale domestic manufacturing and delivery in the U.S. of 100
million doses of Janssen's SARS-CoV-2 investigational vaccine,
Ad26.COV2.S, for use in the United
States following approval or Emergency Use Authorization by
the U.S. Food and Drug Administration (FDA).
The Biomedical Advanced Research and Development Authority
(BARDA), part of the U.S. Department of Health and Human Services'
Office of the Assistant Secretary for Preparedness and Response, in
collaboration with the U.S. Department of Defense, is committing
over $1 billion for this agreement.
The vaccine will be provided at a global not-for-profit basis for
emergency pandemic use. The U.S. government may also purchase an
additional 200 million doses of Ad26.COV2.S under a subsequent
agreement.
"Johnson & Johnson's global team of experts has worked
tirelessly alongside BARDA and scientific partners to pursue a
SARS-CoV-2 vaccine that can help to stop the spread of COVID-19. We
greatly appreciate the U.S. government's confidence in, and support
for, our R&D platform and efforts and the scalability of our
vaccine technology. We are scaling up production in the U.S. and
worldwide to deliver a SARS-CoV-2 vaccine for emergency use," said
Paul Stoffels, M.D., Vice Chairman
of the Executive Committee and Chief Scientific Officer, Johnson
& Johnson.
Johnson & Johnson's efforts to develop a SARS-CoV-2 vaccine
have been undertaken pursuant to an ongoing research and
development collaboration with BARDA and under the oversight of the
FDA. Based on the positive preclinical data recently published in
the peer reviewed journal Nature, the Phase 1/2a
first-in-human clinical trial of the vaccine candidate,
Ad26.COV2.S, is underway in healthy volunteers in the United States and Belgium.
The Company is evaluating one- and two-dose regimens, in its
clinical program and working diligently to ensure broad, global
access to the vaccine following approval or authorization by
regulators. Johnson & Johnson aims to meet its goal to supply
more than one billion doses globally through the course of 2021,
provided the vaccine is safe and effective.
Johnson & Johnson's SARS-CoV-2 vaccine program leverages
Janssen's AdVac® technology. The same technology was
used to develop Janssen's European Commission-approved Ebola
vaccine and construct its HIV, RSV and Zika vaccine candidates.
More than 90,000 individuals have been vaccinated to date using the
Janssen AdVac®-based platform.
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
potential preventive and treatment regimens 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 Janssen
Pharmaceuticals Inc., 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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SOURCE Johnson & Johnson