Agreement provides option for European Union Member
States to secure up to 200 million additional doses for
a total of up to 400 million doses
NEW BRUNSWICK, N.J., Oct. 8,
2020 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ)
(the Company) today announced the European Commission (EC), acting
on behalf of the European Union (EU) Member States, has approved an
Advance Purchase Agreement in which the Janssen Pharmaceutical
Companies will supply 200 million doses of its COVID-19 vaccine
candidate to EU Member States following approval or authorization
from regulators. The EU Member States also have the option to
secure up to 200 million additional doses.
"The COVID-19 pandemic continues to threaten communities
worldwide and we have a responsibility to ensure access to our
COVID-19 vaccine as soon as we can. We appreciate the Commission's
and the Member States' support for our COVID-19 vaccine candidate
and development efforts," said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and
Chief Scientific Officer, Johnson & Johnson.
This contract follows the conclusion of exploratory talks with
the EC. The Company is in ongoing discussions with other
stakeholders, including national governments and global
organizations, as part of its efforts to meet its commitment to
make its vaccine candidate accessible globally, provided the
vaccine has a good safety profile, is efficacious and receives
approval or authorization from regulators.
Separate to the agreement with the EC, as part of the Company's
larger commitment to respond to the COVID-19 pandemic, Johnson
& Johnson has also announced plans to allocate up to 500
million vaccine doses toward international efforts to ensure access
for lower income countries, with delivery beginning mid next year
following approval or authorization from regulators. Recognizing
the unique global demand for COVID-19 vaccines, we are working
tirelessly to further expand the number of available doses.
Johnson & Johnson is developing and testing Janssen's
COVID-19 vaccine candidate in accordance with its usual rigorous
ethical standards of safety and sound scientific principles. The
Company is evaluating a single-dose regimen in its large-scale,
pivotal, multi-country Phase 3 trial (ENSEMBLE) that started
in September. A second Phase 3 study with a two-dose regimen is
planned to start later this year. The Company is committed to
transparency and sharing information related to the Phase 3
ENSEMBLE study – including the study protocol.
Janssen's investigational COVID-19 vaccine leverages Janssen's
AdVac® technology. The same technology was used to
develop Janssen's EC-approved Ebola vaccine regimen and is the
basis for its HIV, RSV and Zika vaccine candidates. To date, more
than 100,000 individuals have been vaccinated with a Janssen
AdVac®-based vaccine. Based on our understanding of the
stability of our vaccines, we anticipate our COVID-19 vaccine
candidate to be compatible with standard distribution channels
without the need for new distribution infrastructure.
For more information on Johnson & Johnson'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
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