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