PR85748

NEW BRUNSWICK, New Jersey, Sept. 23, 2020 /PRNewswire=KYODO JBN/ --

-- First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and

   efficacy of Janssen's COVID-19 vaccine candidate, JNJ-78436735, also known

   as Ad26.COV2.S

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

large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19

vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical

Companies. The initiation of the ENSEMBLE trial follows positive interim

results from the Company's Phase 1/2a clinical study, which demonstrated that

the safety profile and immunogenicity after a single vaccination were

supportive of further development. These results have been submitted to medRxiv

and are due to be published online imminently. Based on these results and

following discussions with the U.S. Food and Drug Administration (FDA),

ENSEMBLE will enroll up to 60,000 volunteers across three continents and will

study the safety and efficacy of a single vaccine dose versus placebo in

preventing COVID-19.

Johnson & Johnson has continued the scaling up of its manufacturing capacity

and remains on track to meet its goal of providing one billion doses of a

vaccine each year. The Company is committed to bringing an affordable vaccine

to the public on a not-for-profit basis for emergency pandemic use and

anticipates the first batches of a COVID-19 vaccine to be available for

emergency use authorization in early 2021, if proven to be safe and effective.

Johnson & Johnson will develop and test its COVID-19 vaccine candidate in

accordance with high ethical standards and sound scientific principles.

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=2925902-1&h=1522581176&u=https%3A%2F%2Fwww.jnj.com%2Fcoronavirus%2Fcovid-19-phase-3-study-clinical-protocol&a=study+protocol ).

"As COVID-19 continues to impact the daily lives of people around the world,

our goal remains the same - leveraging the global reach and scientific

innovation of our company to help bring an end to this pandemic," said Alex

Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson. "As the

world's largest healthcare company, we are bringing to bear our best scientific

minds, and rigorous standards of safety, in collaboration with regulators, to

accelerate the fight against this pandemic. This pivotal milestone demonstrates

our focused efforts toward a COVID-19 vaccine that are built on collaboration

and deep commitment to a robust scientific process. We are committed to

clinical trial transparency and to sharing information related to our study,

including details of our study protocol."

"We remain fully focused on developing an urgently needed, safe and effective

COVID-19 vaccine for people around the world," said Paul Stoffels, M.D., Vice

Chairman of the Executive Committee and Chief Scientific Officer, Johnson &

Johnson. "We greatly value the collaboration and support from our scientific

partners and global health authorities as our global team of experts work

tirelessly on the development of the vaccine and scaling up our production

capacity with a goal to deliver a vaccine for emergency use authorization in early 2021."

The Janssen COVID-19 vaccine candidate leverages the Company's AdVac(R)

technology (https://c212.net/c/link/?t=0&l=en&o=2925902-1&h=1181941441&u=https%3A%2F%2Fwww.janssen.com%2Finfectious-diseases-and-vaccines%2Fpatented-technologies&a=AdVac%C2%AE+technology) platform,

which was also used to develop and manufacture Janssen's European

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

candidates. Janssen's AdVac(R) technology platform has been used to vaccinate

more than 100,000 people to date across Janssen's investigational vaccine programs.

With Janssen's AdVac(R) technology, the vaccine, if successful, is estimated at

launch to remain stable for two years at -20 (Degrees) C and at least three

months at 2-8 (Degrees) C. This makes the vaccine candidate compatible with

standard vaccine distribution channels and would not require new infrastructure

to get it to the people who need it.

PHASE 3 ENSEMBLE STUDY

The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled

clinical trial designed to evaluate the safety and efficacy of a single vaccine

dose versus placebo in up to 60,000 adults 18 years old and older, including

significant representation from those that are over age 60. The trial will

include those both with and without comorbidities associated with an increased

risk for progression to severe COVID-19, and will aim to enroll participants in

Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United

States. In order to evaluate the effectiveness of Janssen's COVID-19 vaccine,

countries and clinical trial sites which have a high incidence of COVID-19 and

the ability to achieve a rapid initiation will be activated.

Built on a legacy of purpose-driven actions and a commitment to diversity and

inclusion, the Company aims to achieve representation of populations that have

been disproportionately impacted by the pandemic in the implementation of its

COVID-19 Phase 3 trial program. In the U.S., this includes significant representation

of Black, Hispanic/Latinx, American Indian and Alaskan Native participants.

ENSEMBLE is being initiated in collaboration with the Biomedical Advanced

Research and Development Authority (BARDA), part of the Office of the Assistant

Secretary for Preparedness and Response at the U.S. Department of Health and

Human Services (HHS) under Other Transaction Agreement HHSO100201700018C, and

the National Institute of Allergy and Infectious Diseases (NIAID), part of the

National Institutes of Health (NIH) at HHS.

In parallel, the Company has also agreed in principle to collaborate

(https://c212.net/c/link/?t=0&l=en&o=2925902-1&h=125471153&u=https%3A%2F%2Fwww.jnj.com%2Four-company%2Fjohnson-johnson-announces-collaboration-in-principle-with-the-united-kingdom-on-additional-phase-3-study-and-agreement-to-supply-its-covid-19-vaccine-candidate&a=collaborate )

with the United Kingdom of Great Britain and Northern Ireland (the UK

Government) on a separate Phase 3 clinical trial in multiple countries to

explore a two-dose regimen of Janssen's vaccine candidate.

"With our vaccine candidate now in our global Phase 3 trial, we are one step

closer to finding a solution for COVID-19. We used a highly scientific and

evidence-based approach to select this vaccine candidate. We are extremely

grateful for the tireless efforts of our researchers and for the vital contributions

of those participants who have volunteered to take part in our studies. Together,

we are working to help combat this pandemic," said Mathai Mammen, M.D., Ph.D.,

Global Head, Janssen Research & Development, LLC, Johnson & Johnson.

The Company is in ongoing discussions with many stakeholders, including

national governments and global organizations, as part of its efforts to meet

its commitment to make the vaccine candidate accessible globally, provided the

vaccine is demonstrated to be safe and effective and following regulatory approval.

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=2925902-1&h=3430601698&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=2925902-1&h=1289483207&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 a

potential preventive vaccine 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.

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SOURCE: Johnson & Johnson

CONTACT: Media Contacts: 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