Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies

Johnson & Johnson

2020/7/31 16:31

PR84968

 

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

 

  -- Study published in Nature shows J&J's investigational SARS-CoV-2 vaccine

     elicits a strong immune response that protects against subsequent infection

 

  -- First-in-human Phase 1/2a clinical trial now underway in United States and

     Belgium; Phase 3 clinical trial expected to commence in September

 

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

vaccine candidate protected against infection with SARS-CoV-2, the virus that

causes COVID-19, in pre-clinical studies. The data, published in Nature

(https://c212.net/c/link/?t=0&l=en&o=2871844-1&h=2914018444&u=https%3A%2F%2Fwww.nature.com%2Farticles%2Fs41586-020-2607-z&a=Nature ), show the Company's investigational adenovirus serotype 26 (Ad26)

vector-based vaccine elicited a robust immune response as demonstrated by

"neutralizing antibodies," successfully preventing subsequent infection and

providing complete or near-complete protection in the lungs from the virus in

non-human primates (NHPs) in the pre-clinical study. Based on the strength of

the data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate,

Ad26.COV2.S, in healthy volunteers, has now commenced (https://c212.net/c/link/?t=0&l=en&o=2871844-1&h=3310778026&u=https%3A%2F%2Fwww.jnj.com%2Fjohnson-johnson-announces-acceleration-of-its-covid-19-vaccine-candidate-phase-1-2a-clinical-trial-to-begin-in-second-half-of-july&a=has+now+commenced ) in the United States and Belgium.

 

"We are excited to see these pre-clinical data because they show our SARS-CoV-2

vaccine candidate generated a strong antibody response and provided protection

with a single dose. The findings give us confidence as we progress our vaccine

development and upscale manufacturing in parallel, having initiated a Phase

1/2a trial in July with the intention to move into a Phase 3 trial in September," said

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

Johnson & Johnson.

 

The robust Janssen COVID-19 clinical trial program, including the Phase 1/2a

clinical trial and the Phase 3 clinical trial program, will evaluate both one-

and two-dose regimens of Ad26.COV2.S in parallel studies. The Phase 1/2a trial

will evaluate the safety, reactogenicity (expected reactions to vaccination,

such as swelling or soreness), and immunogenicity of Ad26.COV2.S in over 1,000

healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.

Planning also is underway for a Phase 2a study in the Netherlands, Spain and

Germany and a Phase 1 study in Japan. For more information about these studies,

please visit www.clinicaltrials.gov.

 

As the Company plans its COVID-19 Phase 3 clinical development program,

discussions are underway with partners with the objective to start a pivotal

Phase 3 clinical trial of the single vaccine dose versus placebo in September,

pending the interim data of the Phase 1 and 2 trials and approval of regulators.

Simultaneously, the Company also is planning to start a parallel Phase 3 clinical

trial of a two-dose regimen versus placebo.

 

The Company also will emphasize representation of populations that have been

disproportionately impacted by the pandemic as it designs and implements its

COVID-19 Phase 3 trial program. In the United States, this would include significant

representation of Blacks, Hispanic/Latinx and participants over 65 years of age.

 

The pre-clinical studies were conducted by researchers from Beth Israel

Deaconess Medical Center (BIDMC) in collaboration with the Janssen

Pharmaceutical Companies of Johnson & Johnson and others as part of its ongoing

collaboration (https://c212.net/c/link/?t=0&l=en&o=2871844-1&h=4189318692&u=https%3A%2F%2Fwww.jnj.com%2Fjohnson-johnson-announces-collaboration-with-the-beth-israel-deaconess-medical-center-to-accelerate-covid-19-vaccine-development&a=collaboration )

to accelerate the development of a SARS-CoV-2 vaccine.

 

Dan Barouch, M.D., Ph.D., Director of the Center for Virology and Vaccine

Research at BIDMC and the Ragon Institute, stated, "The pre-clinical data,

generated in collaboration with the Johnson & Johnson team, highlights the

potential of this SARS-CoV-2 vaccine candidate. Moreover, the data suggest that

antibody levels may serve as a biomarker for vaccine-mediated protection."

 

In the studies, researchers first immunized the NHPs with a panel of vaccine

prototypes, and then challenged them with SARS-CoV-2 infection. The scientists

found that, of seven vaccine prototypes tested in the study, Ad26.COV2.S

(referred to in the Nature article as Ad26-S.PP), elicited the highest levels

of neutralizing antibodies to SARS-CoV-2. The level of antibodies correlated

with the level of protection, confirming previous observations and suggesting

they could be a potential biomarker for vaccine-mediated protection. The six

NHPs that received a single immunization with Ad26.COV2.S showed no detectable

virus in the lower respiratory tract after exposure to SARS-CoV-2, and only one

of six showed very low levels of the virus in a nasal swab at two time points.

 

"As we collectively battle this pandemic, we remain deeply committed to our

goal of providing a safe and effective vaccine to the world. Our pre-clinical

results give us reason to be optimistic as we initiate our first-in-human

clinical trial, and we are excited to enter the next stage in our research and

development toward a COVID-19 vaccine. We know that, if successful, this

vaccine can be rapidly developed, produced on a large scale and delivered

around the world," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen

Research & Development, LLC, Johnson & Johnson.

 

The Company's fundamental responsibility is to provide patients, consumers and

healthcare providers with products that are as safe and effective as possible.

Johnson & Johnson takes an evidence- and science-based, ethics- and

values-driven approach to medical safety, putting patient and consumer

wellbeing first and foremost in its decision making and actions, with an

emphasis on transparency.

 

As Johnson & Johnson progresses the clinical development of SARS-CoV-2, the

Company continues to increase manufacturing capacity and is in active

discussions with global strategic partners to support worldwide access. 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.

 

This project has been funded in whole or in part with Federal funds from the

Office of the Assistant Secretary for Preparedness and Response, Biomedical

Advanced Research and Development Authority, under Other Transaction Agreement

HHSO100201700018C.

 

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=2871844-1&h=2115787610&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=2871844-1&h=4273830783&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 Research & Development LLC., 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 or

Seema Kumar, +1 908-405-1144, SKumar10@its.jnj.com or Katie Buckley, +44

7900-655-261, KBuckle8@its.jnj.com or Investor Relations: Chris DelOrefice, +1

732-524-2955 or Jennifer McIntyre, +1 732-524-3922

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