Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen's COVID-19 Vaccine Candidate

Johnson & Johnson

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

(https://c212.net/c/link/?t=0&l=en&o=2944135-1&h=3501919193&u=https%3A%2F%2Fwww.jnj.com%2Four-company%2Fdiscussions-progress-between-johnson-johnson-and-the-european-commission-regarding-companys-investigational-covid-19-vaccine&a=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 (https://c212.net/c/link/?t=0&l=en&o=2944135-1&h=41111230&u=https%3A%2F%2Fwww.jnj.com%2Flatest-news%2Fjohnson-johnson-signs-communique-on-expanded-global-access-for-covid-19-vaccines&a=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)

(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)

technology (https://c212.net/c/link/?t=0&l=en&o=2944135-1&h=266619149&u=https%3A%2F%2Fwww.janssen.com%2Finfectious-diseases-and-vaccines%2Fvaccine-technology&a=AdVac%C2%AE+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(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

(https://c212.net/c/link/?t=0&l=en&o=2944135-1&h=1999237752&u=http%3A%2F%2Fwww.twitter.com%2Fjnjnews&a=%40JNJNews ).

 

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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