Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen's COVID-19 Vaccine Candidate
PR86011
NEW BRUNSWICK, N.J., Oct. 8, 2020 /PRNewswire=KYODO JBN/ --
-- 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
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
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)
(https://c212.net/c/link/?t=0&l=en&o=2944135-1&h=2569478470&u=https%3A%2F%2Fwww.jnj.com%2Fjohnson-johnson-initiates-pivotal-global-phase-3-clinical-trial-of-janssens-covid-19-vaccine-candidate&a=large-scale%2C+pivotal%2C+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 (https://c212.net/c/link/?t=0&l=en&o=2944135-1&h=3784548130&u=https%3A%2F%2Fwww.jnj.com%2Fcoronavirus%2Fcovid-19-phase-3-study-clinical-protocol&a=study+protocol ).
Janssen's investigational COVID-19 vaccine leverages Janssen's AdVac(R)
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(R)-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 (https://c212.net/c/link/?t=0&l=en&o=2944135-1&h=4152939101&u=https%3A%2F%2Ftwitter.com%2FJanssenGlobal&a=%40JanssenGlobal ).
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
CONTACT: Jake Sargent, +1 202-569-5086, JSargen3@its.jnj.com; Seema Kumar, +1
908-405-1144, SKumar10@its.jnj.com; Katie Buckley, +44 7900-655-261,
KBuckle8@its.jnj.com; Investor Relations: Chris DelOrefice, +1 732-524-2955,
Jennifer McIntyre, +1 732-524-3922
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