Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use

PR83494

NEW BRUNSWICK, New Jersey, March 30, 2020 /PRNewswire=KYODO JBN/ --

- Johnson & Johnson and BARDA Together Commit More than $1 Billion to Novel

Coronavirus Vaccine Research and Development; Company Expects to Initiate Phase

1 Human Clinical Studies of Vaccine Candidate at Latest by September 2020

- Johnson & Johnson Will Establish New U.S. Vaccine Manufacturing Capabilities

and Additional Production Capacity Outside the U.S. to Begin Production at Risk

to Help Ensure Global Vaccine Supply

Johnson & Johnson (NYSE: JNJ) (the Company) today announced the selection of a

lead COVID-19 vaccine candidate from constructs it has been working on since

January 2020; the significant expansion of the existing partnership between the

Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical

Advanced Research and Development Authority (BARDA); and the rapid scaling of

the Company's manufacturing capacity with the goal of providing global supply

of more than one billion doses of a vaccine. The Company expects to initiate

human clinical studies of its lead vaccine candidate at the latest by September

2020 and anticipates the first batches of a COVID-19 vaccine could be available

for emergency use authorization in early 2021, a substantially accelerated

timeframe in comparison to the typical vaccine development process.

Through a landmark new partnership, BARDA, which is part of the Office of the

Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department

of Health and Human Services, and Johnson & Johnson together have committed

more than $1 billion of investment to co-fund vaccine research, development,

and clinical testing. Johnson & Johnson will use its validated vaccine platform

and is allocating resources, including personnel and infrastructure globally,

as needed, to focus on these efforts. Separately, BARDA and the Company have

provided additional funding that will enable expansion of their ongoing work to

identify potential antiviral treatments against the novel coronavirus.

As part of its commitment, Johnson & Johnson is also expanding the Company's

global manufacturing capacity, including through the establishment of new U.S.

vaccine manufacturing capabilities and scaling up capacity in other countries.

The additional capacity will assist in the rapid production of a vaccine and

will enable the supply of more than one billion doses of a safe and effective

vaccine globally. The Company plans to begin production at risk imminently and

is committed to bringing an affordable vaccine to the public on a not-for-profit basis

for emergency pandemic use.

Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said,

"The world is facing an urgent public health crisis and we are committed to

doing our part to make a COVID-19 vaccine available and affordable globally as

quickly as possible. As the world's largest healthcare company, we feel a deep

responsibility to improve the health of people around the world every day.

Johnson & Johnson is well positioned through our combination of scientific

expertise, operational scale and financial strength to bring our resources in

collaboration with others to accelerate the fight against this pandemic."

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

Scientific Officer, Johnson & Johnson, said, "We greatly value the U.S.

government's confidence and support for our R&D efforts. Johnson & Johnson's

global team of experts has ramped up our research and development processes to

unprecedented levels, and our teams are working tirelessly alongside BARDA,

scientific partners, and global health authorities. We are very pleased to have

identified a lead vaccine candidate from the constructs we have been working on

since January. We are moving on an accelerated timeline toward Phase 1 human

clinical trials at the latest by September 2020 and, supported by the global

production capability that we are scaling up in parallel to this testing, we

expect a vaccine could be ready for emergency use in early 2021."

Johnson & Johnson's Lead COVID-19 Vaccine Candidate

Johnson & Johnson began efforts in January 2020, as soon as the novel

coronavirus (COVID-19) sequence became available, to research potential vaccine

candidates. Research teams at Janssen, in collaboration with Beth Israel

Deaconess Medical Center, part of Harvard Medical School, constructed and

tested multiple vaccine candidates using the Janssen AdVac(R) technology

(https://c212.net/c/link/?t=0&l=en&o=2763873-1&h=2093926773&u=https%3A%2F%2Fwww.janssen.com%2Finfectious-diseases-and-vaccines%2Fpatented-technologies&a=AdVac%C2%AE+technology ).

Through collaborations with scientists at multiple academic institutions, the

vaccine constructs were then tested to identify those with the most promise in

producing an immune response in preclinical testing.

Based on this work, Johnson & Johnson has identified a lead COVID-19 vaccine

candidate (with two back-ups), which will progress into the first manufacturing

steps. Under an accelerated timeline, the Company is aiming to initiate a Phase

1 clinical study in September 2020, with clinical data on safety and efficacy

expected to be available by the end of the year. This could allow vaccine

availability for emergency use in early 2021. For comparison, the typical

vaccine development process involves a number of different research stages,

spanning 5 to 7 years, before a candidate is even considered for approval.

For more than 20 years, Johnson & Johnson has invested billions of dollars in antivirals and vaccine capabilities. The COVID-19 vaccine program is leveraging Janssen's proven AdVac(R)

and PER.C6(R) technologies ( https://c212.net/c/link/?t=0&l=en&o=2763873-1&h=392506868&u=https%3A%2F%2Fwww.janssen.com%2Finfectious-diseases-and-vaccines%2Fpatented-technologies&a=AdVac%C2%AE+and+PER.C6%C2%AE+technologies )

that provide the ability to rapidly develop new vaccine candidates and upscale production of

the optimal vaccine candidate. The same technology was used to develop and manufacture

the Company's Ebola vaccine and construct our Zika, RSV, and HIV vaccine candidates

which are in Phase 2 or Phase 3 clinical development stages.

Expanded Antiviral Research

In addition to the vaccine development efforts, BARDA and Johnson & Johnson

have also expanded their partnership to accelerate Janssen's ongoing work in

screening compound libraries, including compounds from other pharmaceutical

companies. The Company's aim is to identify potential treatments against the

novel coronavirus. Johnson & Johnson and BARDA are both providing funding as

part of this partnership. These antiviral screening efforts are being conducted

in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven),

in Belgium.

As announced in February 2020, the Company and BARDA have been working closely

with global partners to screen Janssen's library of antiviral molecules to accelerate

the discovery of potential COVID-19 treatments.

COVID-19 belongs to a group of viruses called coronaviruses that attack the

respiratory system. There is currently no approved vaccine, treatment or cure

for COVID-19.

For more information on Johnson & Johnson's multi-pronged approach to

combatting 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=2763873-1&h=4140229718&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=2763873-1&h=1986511987&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 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.

Logo - https://mma.prnewswire.com/media/403394/Johnson_and_Johnson_Logo.jpg

SOURCE Johnson & Johnson

CONTACT: Media Contacts: Jake Sargent, + 1 202-569-5086, JSargen3@ITS.JNJ.com;

Cristal Downing, +1 908-616-8833, cdowning@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;

Lesley Fishman, +1 732-524-3922