Country for PR: United States
Contributor: PR Newswire New York
Thursday, July 30 2020 - 20:58
Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies
NEW BRUNSWICK, New Jersey, July 30, 2020 /PRNewswire-AsiaNet/ --

  -- Study published in Nature shows J&J's investigational SARS-CoV-2 vaccine
     elicits a strong immune response that protects against subsequent

  -- 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 ( 
), 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 ( 
) 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

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 ( 
) 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 

For more information on Johnson & Johnson's multi-pronged approach to 
combatting the pandemic, visit:

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 Follow us at @JNJNews ( 

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 Follow us at @JanssenGlobal ( 

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, 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 -  

SOURCE: Johnson & Johnson

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