NEW BRUNSWICK, N.J.,
Feb. 16, 2021 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) (the Company) today announced that
Janssen-Cilag International N.V., has submitted a conditional
Marketing Authorisation Application (cMAA) to the European
Medicines Agency (EMA) seeking authorisation for its
investigational single-dose Janssen COVID-19 vaccine candidate. The
submission is based on topline efficacy and safety data from
the Phase 3 ENSEMBLE clinical trial.
"Throughout Europe, there remains an urgent need for additional
COVID-19 vaccines, and today's submission is a significant step
forward in ensuring the European Union has another option to help
reduce the impact the pandemic has had in Europe and around the world," said
Paul Stoffels, M.D., Vice Chairman
of the Executive Committee and Chief Scientific Officer at Johnson
& Johnson. "We stand ready to begin distributing our vaccine
within the European Union in the second quarter of 2021."
Once a conditional Marketing Authorisation has been granted, the
Company must fulfill specific obligations within defined timelines,
including the supply of additional data.
The Company announced in December it had initiated a
rolling submission with the EMA for its investigational Janssen
COVID-19 vaccine, enabling the EMA to review data as they become
available. In addition, rolling submissions for the investigational
single-dose COVID-19 vaccine have been initiated in several
countries worldwide and with the World Health Organization (WHO).
The Company filed for Emergency Use Authorization (EUA) in
the United States on February 4, 2021.
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
-20°C (-4°F), at least three months of which can be stored in most
standard refrigerators at temperatures of 2°-8°C (36°F–46°F).
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.
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.
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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