NEW BRUNSWICK, N.J.,
June 10, 2020 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced that through its Janssen Pharmaceutical Companies
(Janssen) it has accelerated the initiation of the Phase 1/2a
first-in-human clinical trial of its investigational SARS-CoV-2
vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in
September, the trial is now expected to commence in the second half
of July.
Paul Stoffels, M.D., Vice
Chairman of the Executive Committee and Chief Scientific Officer,
Johnson & Johnson, said, "Based on the strength of the
preclinical data we have seen so far and interactions with the
regulatory authorities, we have been able to further accelerate the
clinical development of our investigational SARS-CoV-2 vaccine,
Ad26.COV2-S, recombinant. Simultaneously, we are continuing our
efforts to build important global partnerships and invest in our
vaccine production technology and manufacturing capabilities. Our
goal is to ensure we can deliver a vaccine to the world and protect
people everywhere from this pandemic."
The randomized, double-blind, placebo-controlled Phase 1/2a
study will evaluate the safety, reactogenicity (response to
vaccination), and immunogenicity (immune response) of the
investigational SARS-CoV-2 vaccine, Ad26.COV2-S,
recombinant in 1045 healthy adults aged 18 to 55 years, as
well as adults aged 65 years and older. The study will take place
in the U.S. and Belgium.
The Company is in discussions with the National Institutes of
Allergy and Infectious Diseases with the objective to start the
Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical
trial ahead of its original schedule, pending outcome of phase 1
studies and approval of regulators.
As the Company progresses the clinical development of its
investigational SARS-CoV-2 vaccine, Ad26.COV2-S,
recombinant, it continues to increase manufacturing capacity
and is in active discussions with global partners to ensure
worldwide access. The Company committed to the goal of supplying
more than one billion doses globally through the course of 2021,
provided the vaccine is a safe and effective.
Johnson & Johnson's efforts to expedite development and
production of a SARS-CoV-2 vaccine are enhanced by a
collaboration between Janssen and the Biomedical Advanced
Research and Development Authority (BARDA), part of the Office of
the Assistant Secretary for Preparedness and Response (ASPR) at the
U.S. Department of Health & Human Services.
COVID-19 is caused by SARS-CoV-2, which belongs to a group of
viruses called coronaviruses that attack the respiratory system.
There is currently no approved vaccine for COVID-19.
For more information on Johnson & Johnson's multi-pronged
approach to combatting 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 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 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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SOURCE Johnson & Johnson