NEW BRUNSWICK, N.J.,
Feb. 19, 2021 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) (the Company) announced that
Janssen-Cilag International N.V. has submitted for Emergency Use
Listing (EUL) to the World Health Organization (WHO) for the
investigational single-dose Janssen COVID-19 vaccine candidate. The
data package delivered today includes interim efficacy and safety
results from the Phase 3 ENSEMBLE clinical trial. The Company's
rolling submission of clinical data to WHO is now complete.
"Our filing with the World Health Organization marks another
important step in our effort to combat COVID-19 and also in our
unwavering commitment to equitable access," said Paul Stoffels, M.D., Vice Chairman of the
Executive Committee and Chief Scientific Officer of Johnson &
Johnson. "If we are to end the global pandemic, life-saving
innovations like vaccines must be within reach for all
countries."
The EUL procedure streamlines the process by which new or
unlicensed products can be assessed for use during public health
emergencies by governments and UN procurement agencies. The EUL
process expedites access to such products in many countries around
the world and is also a prerequisite to supply vaccines to the new
COVAX Facility, a global mechanism for pooled procurement and
distribution of COVID-19 vaccines in 190 participating countries,
including 92 lower-income countries.
In December 2020, the Company
entered into an agreement in principle with Gavi, the Vaccine
Alliance (Gavi) in support of the COVAX Facility. The Company and
Gavi expect to enter into an Advance Purchase Agreement (APA) that
would provide up to 500 million doses of the Janssen vaccine to
COVAX through 2022.
Commitment to Equitable Access
Equitable access is at
the forefront of Johnson & Johnson's COVID-19 response. The
Company's single-dose vaccine candidate and its compatibility with
standard vaccine distribution channels align with WHO's
recommendations for medical interventions in a pandemic setting,
which emphasize ease of distribution, administration and
compliance.
The Company is committed to ensuring global access to its
COVID-19 vaccine candidate on a not-for-profit basis during the
acute phase of the pandemic. In September
2020, Johnson & Johnson joined other life sciences
companies and the Bill & Melinda Gates Foundation in signing an
unprecedented communiqué which outlined a steadfast commitment
to facilitating equitable access to the innovations being developed
to fight the pandemic.
Regulatory Filings
The Company filed for Emergency Use
Authorization (EUA) in the United
States on February 4, 2021 and
submitted a Conditional Marketing Authorisation Application
(cMAA) in the European Union on February 15, 2021. In addition, rolling
submissions for the investigational single-dose COVID-19 vaccine
have been initiated in several countries worldwide. The
Company will continue to provide data on an ongoing basis in
support of WHO prequalification for the Janssen COVID-19 vaccine
candidate.
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 trial, conducted in eight countries across three
continents, includes a diverse and broad population. 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 Company announced
topline efficacy and safety data from ENSEMBLE on January 29, 2021.
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