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NEW BRUNSWICK, N.J.,
January 29, 2021 – Johnson
& Johnson (NYSE: JNJ) (the Company) today announced topline efficacy
and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the
investigational single-dose COVID-19 vaccine in development at its Janssen
Pharmaceutical Companies met all primary and key secondary endpoints. The
topline safety and efficacy data are based on 43,783 participants accruing
468 symptomatic cases of COVID-19.
The Phase 3 ENSEMBLE
study is designed to evaluate the efficacy and safety of the Janssen
COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with
co-primary endpoints of 14 days and 28 days following vaccination. Among
all participants from different geographies and including those infected
with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was
66% effective overall in preventing moderate to severe COVID-19, 28 days
after vaccination. The onset of protection was observed as early as day 14.
The level of protection against moderate to severe COVID-19 infection was
72% in the United States, 66% in Latin America and 57% in South Africa, 28
days post-vaccination.
“Johnson &
Johnson embarked on the global effort to combat the COVID-19 pandemic a
year ago, and has brought the full force of our capabilities, as well as
tremendous public-private partnerships, to enable the development of a single-shot
vaccine. Our goal all along has been to create a simple, effective solution
for the largest number of people possible, and to have maximum impact to
help end the pandemic,” said Alex Gorsky, Chairman, Board of Directors and
Chief Executive Officer, Johnson & Johnson. “We’re proud to have
reached this critical milestone and our commitment to address this global
health crisis continues with urgency for everyone, everywhere.”
Prevention of severe
disease; protection against COVID-related hospitalization and death
The vaccine
candidate was 85 percent effective in preventing severe disease across all
regions studied, [i] 28 days after vaccination in all adults 18
years and older. Efficacy against severe disease increased over time with
no cases in vaccinated participants reported after day 49.
The Janssen COVID-19
vaccine candidate demonstrated complete protection against COVID-related
hospitalization and death, 28 days post-vaccination. There was a clear
effect of the vaccine on COVID-19 cases requiring medical intervention
(hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane
oxygenation (ECMO)), with no reported cases among participants who had
received the Janssen COVID-19 vaccine, 28 days post-vaccination.
“These topline
results with a single-shot COVID-19 vaccine candidate represent a promising
moment. The potential to significantly reduce the burden of severe disease,
by providing an effective and well-tolerated vaccine with just one
immunization, is a critical component of the global public health
response,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee
and Chief Scientific Officer, Johnson & Johnson. “A one-shot vaccine is
considered by the World Health Organization to be the best option in
pandemic settings, enhancing access, distribution and compliance.
Eighty-five percent efficacy in preventing severe COVID-19 disease and
prevention of COVID-19-related medical interventions will potentially
protect hundreds of millions of people from serious and fatal outcomes of
COVID-19. It also offers the hope of helping ease the huge burden placed on
healthcare systems and communities.”
In the study, the
definition of severe COVID-19 disease included laboratory-confirmed
SARS-CoV-2 and one or more of the following: signs consistent with severe
systemic illness, admission to an intensive care unit, respiratory failure,
shock, organ failure or death, among other factors. Moderate COVID-19
disease was defined as laboratory-confirmed SARS-CoV-2 and one or more of
the following: evidence of pneumonia, deep vein thrombosis, shortness of
breath or abnormal blood oxygen saturation above 93%, abnormal respiratory
rate (≥20); or two or more systemic symptoms suggestive of COVID-19.
Protection was
generally consistent across race, age groups, including adults over 60
years of age (N= 13,610), and across all variants and regions studied,
including South Africa where nearly all cases of COVID-19 (95%) were due to
infection with a SARS-CoV-2 variant from the B.1.351 lineage [ii].
Multi-continent
Study Provides Clinical Data on Multiple Emerging Viral Mutations
The ENSEMBLE study
results include efficacy against newly emerging strains of coronavirus,
including some highly infectious variants present in the US, Latin America
and South Africa. The Phase 3 ENSEMBLE trial is being conducted at the
height of the COVID-19 pandemic in eight countries and three regions, at a
time when disease spread has accelerated throughout the world resulting in
people having increased exposure to the virus.
“These results are a
testament to the extraordinary efforts of everyone involved in our COVID-19
vaccine candidate clinical program, and we are extremely grateful to the
clinical trial staff and trial participants for their invaluable
contributions,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen
Research & Development. “Changing the trajectory of the pandemic will
require mass vaccination to create herd immunity, and a single-dose regimen
with fast onset of protection and ease of delivery and storage provides a
potential solution to reaching as many people as possible. The ability to
avoid hospitalizations and deaths would change the game in combating the
pandemic.”
Trial participants
of the phase 3 ENSEMBLE study continue to be followed for up to two years
for assessments of safety and efficacy. Therefore, these data may be
updated based on ongoing analysis. The comprehensive available data set
will be submitted to a peer-reviewed journal in the coming weeks.
Phase 3 ENSEMBLE
Study Safety Data
The analysis
included a concurrent review of the available Phase 3 ENSEMBLE study safety
data by the Data and Safety Monitoring Board (DSMB), an independent group
of experts, that did not report any significant safety concerns relating to
the vaccine. A review of adverse events indicated that a single-dose of
Janssen’s COVID-19 vaccine candidate was generally well-tolerated.
The safety profile
was consistent with other vaccine candidates using Janssen’s
AdVac® technology among more than 200,000 people to date. Overall
fever rates were 9% and Grade 3 fever 0.2%. Overall serious adverse events
(SAEs) reported were higher in participants who received placebo as
compared to the active vaccine candidate. No anaphylaxis was observed.
Janssen Vaccine
Candidate Access and Distribution
The Company is
committed to bringing an affordable COVID-19 vaccine on a not-for-profit
basis for emergency pandemic use, pending regulatory authorizations.
In addition, the
Janssen vaccine candidate is compatible with standard vaccine distribution
channels. If authorized, Janssen’s single-dose vaccine candidate is
estimated to remain stable for two years at -20°C (-4°F), at least three
months of which can be at temperatures of 2-8°C (36°F–46°F). The Company
will ship the vaccine using the same cold chain technologies it uses today
to transport other innovative medicines.
The Company intends
to file for U.S. Emergency Use Authorization (EUA) in early February and
expects to have product available to ship immediately following
authorization. It expects to share more information on specifics of
deployment as authorizations are secured and contracts are finalized. The
Company’s anticipated manufacturing timeline will enable it to meet its
2021 supply commitments, including those signed with governments and global
organizations.
Phase 3 ENSEMBLE
Study Design
The Phase 3 ENSEMBLE
study is a randomized, double-blind, placebo-controlled clinical trial
designed to evaluate the safety and efficacy of a single-dose vaccine
versus placebo in adults 18 years old and older.
The ENSEMBLE study
was designed to evaluate the safety and efficacy of the Janssen vaccine
candidate in protecting against both moderate and severe COVID-19 disease,
with assessment of efficacy as of day 14 and as of day 28 as co-primary
endpoints.
Phase 3 ENSEMBLE
Study Demographics
The trial, conducted
in eight countries across three continents, includes a diverse and broad
population including 34% (N= 14,672) of participants over age 60.
The study enrolled
44% (N=19,302) of participants in the United States, 41% (N=17,905) in
Central and South America (Argentina, Brazil, Chile, Colombia, Mexico,
Peru) and 15% (N=6,576) in South Africa.
Forty-five percent
of participants are female, 55% male.
Among participants
globally, 59% are White/Caucasian; 45% are Hispanic and/or Latinx; 19% are
Black/African American; 9% are Native American and 3% are Asian. In the
United States, 74% are White/Caucasian; (15% are Hispanic) and/or Latinx;
13% are Black/African American; 6% are Asian and 1% are Native American.
Forty-one percent of
participants in the study had comorbidities associated with an increased
risk for progression to severe COVID-19 (overall 41%, obesity (28.5%), type
2 diabetes (7.3%), hypertension (10.3%), HIV (2.8%); also other
immunocompromised participants were in the study.
Janssen’s Vaccine
Technology
The investigational
Janssen COVID-19 vaccine candidate leverages the Company’s AdVac® vaccine platform , which was also used to
develop and manufacture Janssen’s European Commission-approved Ebola
vaccine regimen and construct its Zika, RSV, and HIV investigational
vaccine candidates.
The Janssen
AdVac® viral vector technology can induce potent and long-lasting
humoral and cellular immune responses, enabling the pursuit of vaccines for
disease targets that are currently unpreventable or untreatable.
Johnson &
Johnson continues to develop and test its COVID-19 vaccine candidate in
accordance with ethical standards and sound scientific principles .
The Company is committed to transparency and sharing information related to its
ongoing clinical studies – including the ENSEMBLE study protocol.
ENSEMBLE 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 (BARDA), under Contract No. HHSO100201700018C,
and in collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH) at the
U.S. Department of Health and Human Services (HHS).
Janssen has worked
with BARDA since 2015 on innovative solutions for influenza, chemical,
biological, radiation and nuclear threats and emerging infectious diseases
such as Ebola. In February 2020, Janssen and BARDA began work on the
development of a COVID-19 vaccine based on Janssen’s AdVac® technology.
The Janssen
Pharmaceutical Companies entered into a collaboration with the Beth Israel Deaconess Medical
Center (BIDMC) to support the development of the preventive vaccine
candidate for COVID-19.
Janssen’s COVID-19
vaccine program has been designed to be thorough and driven by science. As
such, the Company is also investigating immune responses for different
doses and dosing regimens as well as studying a two-dose regimen of its
COVID-19 vaccine candidate for efficacy in the Phase 3 ENSEMBLE 2 study.
For more information
on the Company’s multi-pronged approach to helping combat the pandemic,
visit: www.jnj.com/coronavirus.
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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 of Johnson & Johnson
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.
The company plans
to hold an investor webcast to share the results and provide opportunity
for Q&A today at 9:00am EST. The call will be hosted by Chris
DelOrefice, Vice President of Investor Relations and Mathai Mammen, Global
Head of Janssen Research and Development. The webcast is accessible
at www.investor.jnj.com and telephone, for both “listen-only”
participants and financial analysts who wish to take part in the question
and answer portion of the call. Please dial (877) 869-3847 in the U.S. and
(201) 689-8261 outside of the U.S.
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 its
COVID-19 vaccine candidate. 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.
[i] https://www.jnj.com/coronavirus/covid-19-phase-3-study-clinical-protocol
[ii] The B.1.351 lineage also known
as 501Y.V2 variant and 20H/501Y.V2 (formerly 20C/501Y.V2) is a variant
of SARS-CoV-2, the virus that causes COVID-19
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