NEW BRUNSWICK, N.J.,
Feb. 4, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced that Janssen Biotech, Inc., has submitted an application
to the U.S. Food and Drug Administration (FDA) requesting Emergency
Use Authorization (EUA) for its investigational single-dose Janssen
COVID-19 vaccine candidate. The Company's EUA submission is based
on topline efficacy and safety data from the Phase 3 ENSEMBLE
clinical trial, demonstrating that the investigational single-dose
vaccine met all primary and key secondary endpoints. The Company
expects to have product available to ship immediately following
authorization.
"Today's submission for Emergency Use Authorization of our
investigational single-shot COVID-19 vaccine is a pivotal step
toward reducing the burden of disease for people globally and
putting an end to the pandemic," said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and
Chief Scientific Officer at Johnson & Johnson. "Upon
authorization of our investigational COVID-19 vaccine for emergency
use, we are ready to begin shipping. With our submission to the FDA
and our ongoing reviews with other health authorities around the
world, we are working with great urgency to make our
investigational vaccine available to the public as quickly as
possible."
The Company has initiated rolling submissions with several
health agencies outside the U.S., and will submit a Conditional
Marketing Authorisation Application (cMAA) with the European
Medicines Agency in the coming weeks.
Manufacturing and Supply Chain Information
The Janssen investigational vaccine is compatible with standard
vaccine distribution channels. If authorized, Janssen's
investigational single-dose vaccine is estimated to remain stable
for two years at -4°F (-20°C), at least three months of which can
be stored in most standard refrigerators at temperatures of
36°F–46°F (2°-8°C). The Company will ship the vaccine using the
same cold chain technologies it uses today to transport other
innovative medicines.
Janssen's Investigational COVID-19 Vaccine
The Janssen investigational COVID-19 vaccine leverages the
Company's AdVac® vaccine platform, which was also used to
develop and manufacture Janssen's European Commission-approved
Ebola vaccine regimen and construct its investigational Zika, RSV,
and HIV vaccines. The safety profile observed was consistent with
other investigational vaccines using Janssen's
AdVac® technology among more than 200,000 people to
date.
Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE study is a randomized, double-blind,
placebo-controlled clinical trial in adults 18 years old and
older. The study was designed to evaluate the safety and
efficacy of the Janssen investigational vaccine in protecting
against both moderate and severe COVID-19 disease, with
assessment of efficacy as of day 14 and as of day 28 as co-primary
endpoints.
The trial, conducted in eight countries across three continents,
includes a diverse and broad population.
Research and development activities for the investigational
Janssen COVID-19 vaccine including the ENSEMBLE clinical trial and
the delivery of doses for the U.S. has been funded in whole or in
part with federal funds from the U.S. Department of Health and
Human Services, Office of the Assistant Secretary for Preparedness
and Response, Biomedical Advanced Research and Development
Authority (BARDA), under Contract No. HHSO100201700018C, and in
collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH)
at the U.S. Department of Health and Human Services
(HHS).
Janssen has worked with BARDA since 2015 on innovative solutions
for influenza, chemical, biological, radiation and nuclear threats
and emerging infectious diseases such as Ebola. In February 2020, Janssen and BARDA began work on
the development of a COVID-19 vaccine based on Janssen's
AdVac® technology.
For more information on the Company'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 of Johnson &
Johnson
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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SOURCE Johnson & Johnson