Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine

Johnson & Johnson

PR85030

 

NEW BRUNSWICK, New Jersey, Aug. 5, 2020 /PRNewswire=KYODO JBN/ --

 

    -- Company working to ensure broad global access to COVID-19 vaccine

candidate, following approval from regulators

 

Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen

Pharmaceutical Companies have entered into an agreement with the U.S.

government for the large scale domestic manufacturing and delivery in the U.S.

of 100 million doses of Janssen's SARS-CoV-2 investigational vaccine,

Ad26.COV2.S, for use in the United States following approval or Emergency Use

Authorization by the U.S. Food and Drug Administration (FDA).

 

The Biomedical Advanced Research and Development Authority (BARDA)

[https://c212.net/c/link/?t=0&l=en&o=2877164-1&h=2085312140&u=https%3A%2F%2Fwww.phe.gov%2Fbarda&a=BARDA ],

part of the U.S. Department of Health and Human Services' Office of the

Assistant Secretary for Preparedness and Response, in collaboration with the

U.S. Department of Defense, is committing over $1 billion for this agreement.

The vaccine will be provided at a global not-for-profit basis for emergency

pandemic use. The U.S. government may also purchase an additional 200 million

doses of Ad26.COV2.S under a subsequent agreement.

 

"Johnson & Johnson's global team of experts has worked tirelessly alongside

BARDA and scientific partners to pursue a SARS-CoV-2 vaccine that can help to

stop the spread of COVID-19. We greatly appreciate the U.S. government's

confidence in, and support for, our R&D platform and efforts and the

scalability of our vaccine technology. We are scaling up production in the U.S.

and worldwide to deliver a SARS-CoV-2 vaccine for emergency use," said Paul

Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific

Officer, Johnson & Johnson.

 

Johnson & Johnson's efforts to develop a SARS-CoV-2 vaccine have been

undertaken pursuant to an ongoing research and development collaboration with

BARDA and under the oversight of the FDA. Based on the positive preclinical data

[https://c212.net/c/link/?t=0&l=en&o=2877164-1&h=742065667&u=https%3A%2F%2Fwww.jnj.com%2Fsingle-dose-of-johnson-johnson-covid-19-vaccine-candidate-demonstrates-robust-protection-in-pre-clinical-studies&a=preclinical+data ]

recently published in the peer reviewed journal Nature [https://c212.net/c/link/?t=0&l=en&o=2877164-1&h=1054653261&u=https%3A%2F%2Fwww.nature.com%2Farticles%2Fs41586-020-2607-z&a=Nature ], the Phase 1/2a first-in-human clinical trial of the vaccine candidate,

Ad26.COV2.S, is underway in healthy volunteers in the United States and Belgium.

 

The Company is evaluating one- and two-dose regimens, in its clinical program

and working diligently to ensure broad, global access to the vaccine following

approval or authorization by regulators. Johnson & Johnson aims to meet its

goal to supply more than one billion doses globally through the course of 2021,

provided the vaccine is safe and effective.

 

Johnson & Johnson's SARS-CoV-2 vaccine program leverages Janssen's AdVac(R)

technology [https://c212.net/c/link/?t=0&l=en&o=2877164-1&h=2512207854&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 European

Commission-approved Ebola vaccine and construct its HIV, RSV and Zika vaccine

candidates. More than 90,000 individuals have been vaccinated to date using the

Janssen AdVac(R)-based platform.

 

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=2877164-1&h=3983574171&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=2877164-1&h=1842455742&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

908-405-1144SKumar10@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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