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
NEW BRUNSWICK, New Jersey,
July 30, 2020 /PRNewswire/
-- 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 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 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.
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.
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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