NEW BRUNSWICK, N.J.,
Sept. 21, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced new data reinforcing the strong and long-lasting
protection of its COVID-19 vaccine. New data also showed that
protection against COVID-19 increases when a booster shot of the
Johnson & Johnson vaccine is administered. The safety profile
of the vaccine remained consistent and was generally well-tolerated
when administered as a booster.
"Our large real-world evidence and Phase 3 studies confirm that
the single-shot Johnson & Johnson vaccine provides strong and
long-lasting protection against COVID-19-related hospitalizations.
Additionally, our Phase 3 trial data further confirm protection
against COVID-19-related death," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen
Research & Development, Johnson & Johnson. "Our single-shot
vaccine generates strong immune responses and long-lasting immune
memory. And, when a booster of the Johnson & Johnson COVID-19
vaccine is given, the strength of protection against COVID-19
further increases."
"It is critical to prioritize protecting as many people as
possible against hospitalization and death given the continued
spread of COVID-19. A single-shot COVID-19 vaccine that is easy to
use, distribute and administer, and that provides strong and
long-lasting protection is crucial to vaccinating the global
population," said Paul Stoffels,
M.D., Vice Chairman of the Executive Committee and Chief Scientific
Officer at Johnson & Johnson. "At the same time, we now have
generated evidence that a booster shot further increases protection
against COVID-19 and is expected to extend the duration of
protection significantly."
The Company has provided available data to the U.S. Food and
Drug Administration (FDA) and plans to submit the data to other
regulators, the World Health Organization (WHO) and National
Immunization Technical Advisory Groups (NITAGs) worldwide to inform
decision-making on local vaccine administration strategies, as
needed.
The data are summarized below:
Johnson & Johnson single-shot vaccine showed strong and
long-lasting protection in the real world
The
largest real-world evidence study for a COVID-19 vaccine
reported to date in the U.S. demonstrated stable vaccine
effectiveness of 79 percent (CI, 77%-80%) for COVID-19-related
infections and 81 percent (CI, 79%-84%) for COVID-19-related
hospitalizations. There was no evidence of reduced effectiveness
over the study duration, including when the Delta variant became
dominant in the U.S. Sequencing data were not available for
analysis. The study included 390,000 people who received the
Johnson & Johnson COVID-19 vaccine versus approximately 1.52
million unvaccinated people matched on age, sex, time, three-digit
zip code, and comorbidities and predictors for COVID-19 infection
severity conducted from March to late July
2021.
These data were consistent with the Phase 3 ENSEMBLE trial,
where strong protection against severe/critical disease and death
was observed at least 28 days post-final vaccination:
- 75 percent overall efficacy (CI, 65%-82%) against
severe/critical COVID-19, across all age cohorts and all countries
included in the study.
- 74 percent efficacy in the U.S. against severe/critical
COVID-19 (CI, 39%-91%); 89 percent against hospitalization (CI,
24%-100%); 83 percent against COVID-19-related death (CI,
41%-97%).
Booster shot at two months provided 94 percent protection
against COVID-19 in the U.S.
The Phase 3 ENSEMBLE 2 study
showed that another shot of the Johnson & Johnson COVID-19
vaccine given 56 days after the first provided:
- 100 percent protection (CI, 33%-100%) against severe/critical
COVID-19 – at least 14 days post-final vaccination.
- 75 percent protection against symptomatic (moderate to
severe/critical) COVID-19 globally (CI, 55%-87%).
- 94 percent protection against symptomatic (moderate to
severe/critical) COVID-19 in the U.S. (CI, 58%-100%).
When a booster of the Johnson & Johnson COVID-19 vaccine was
given two months after the first shot, antibody levels rose to four
to six times higher than observed after the single shot.
Booster shot at six months provided 12-fold increase in
antibodies
When a booster of the Johnson & Johnson
COVID-19 vaccine was given six months after the single shot,
antibody levels increased nine-fold one week after the booster and
continued to climb to 12-fold higher four weeks after the booster.
All rises were irrespective of age.
The Johnson & Johnson single-shot COVID-19 vaccine,
developed by its Janssen Pharmaceutical Companies of Johnson &
Johnson, received an Emergency Use Authorization (EUA) in
the United States on
February 27, 2021
and Conditional Marketing Authorization (CMA) by the
European Commission on March 11. The
World Health Organization (WHO) issued Emergency Use
Listing on March 12, and the
Company received an interim recommendation by the
Strategic Advisory Group of Experts (SAGE) on Immunization for the
WHO on March 17. Many more
authorizations have been granted in countries worldwide, and
regulatory submissions are ongoing.
- Additional Notes -
Real-World Evidence Study
In the largest
real-world evidence Vaccine Effectiveness (VE) study of
participants receiving the Johnson & Johnson single-shot
COVID-19 vaccine in the U.S. to date, the Janssen R&D Data
Science team, Harvard University and
Aetion utilized the HealthVerity database, which consisted of
longitudinal de-identified patient-level information representative
of the U.S. population. This study compared approximately 390,000
people who received the Company's single-shot COVID-19 vaccine
versus approximately 1.52 million unvaccinated people matched on
age, sex, time, three-digit zip code, and comorbidities and
predictors for COVID-19 infection severity.
This study is a longitudinal cohort design, using robust
propensity matching methods to create a comparator cohort to assess
real-world VE. All analyses were performed using the Aetion
Evidence Platform, which is a scientifically validated software
that is also used by regulators, payers, and health technology
assessment bodies to assess the safety, effectiveness, and value of
medical technologies. All transformations of the raw data are
preserved for full reproducibility and audit trails are available,
including a quality check of the data ingestion process.
In the real-world U.S. data, the Johnson & Johnson
single-shot COVID-19 vaccine showed VE of 81 percent (CI, 79%-84%)
for COVID-19-related hospitalizations and effectiveness of 79
percent (CI, 77%-80%) for COVID-19-related infections (VE was
corrected to compensate for vaccination status misclassification
due to under-recording of true vaccination status in health care
claims data). Uncorrected VE was 69 percent (CI, 67%-71%) for
COVID-19-related infections; VE of 73 percent (CI, 69%-76%) for
COVID-19 hospitalizations.
The Johnson & Johnson single-shot COVID-19 vaccine showed VE
against COVID-19-related hospitalizations at 86 percent (CI,
83%-89%) for participants younger than 60 years, and 78 percent
(CI, 74%-81%) for those 60 years and older. VE against COVID-19
infections was 81 percent (CI, 79%-82%) for people younger than 60
years, and 75 percent (CI, 73%-78%) for those 60 years and older.
These results are consistent with what was observed in the ENSEMBLE
study.
ENSEMBLE 1 Study
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 Johnson & Johnson vaccine candidate in
protecting against moderate to severe/critical COVID-19 disease,
with assessment of efficacy as of day 14 and as of day 28 as
co-primary endpoints.
In the Phase 3 ENSEMBLE study, a single dose of the Johnson
& Johnson COVID-19 vaccine offered strong and durable overall
efficacy (75%; CI, 65%-82%; n=46 cases vaccine arm, n=176 cases
placebo arm) against severe/critical COVID-19, across all age
cohorts and all countries included in the study, after at least 28
days post-vaccination. While efficacy against severe/critical
COVID-19 caused by the initial circulating SARS-COV-2 reference
strain (Wuhan) remained high (93%;
CI, 54%-99%; n=1 case vaccine arm, n=14 cases placebo arm), there
was somewhat lower vaccine efficacy (72%; CI, 56%-82%; n=27 cases
vaccine arm, n=93 cases placebo arm) against severe/critical
disease caused by variants.
The single-dose regimen had 53 percent (CI, 47%-58%; n=433
cases vaccine arm, n=883 cases placebo arm) efficacy against
moderate to severe/critical infection with 58 percent (CI, 35%-74%;
n=30 cases vaccine arm, n=69 cases placebo arm) efficacy against
the reference strain. Efficacy against hospitalizations related to
COVID-19 in the ENSEMBLE trial was 76 percent (CI, 54%-88%; n=16
cases vaccine arm, n=64 cases placebo arm), and efficacy against
COVID-19-related deaths was 83 percent (CI, 41%-97%; n=3 cases
vaccine arm, n=17 cases placebo arm).
In the U.S., the ENSEMBLE trial demonstrated vaccine efficacy
against moderate to severe/critical COVID-19 infection of 70
percent 28-days post-vaccination (CI, 61%-77%; n=77 cases vaccine
arm, n=239 cases placebo arm), 74 percent against severe/critical
infection (CI, 39%-91%; n=7 cases vaccine arm, n=26 cases placebo
arm) and 89 percent against hospitalization (CI, 24%-100%; n=1 case
vaccine arm, n=9 cases placebo arm).
Median follow-up time in the ENSEMBLE study was four months,
with 23 percent of the participants with follow-up of greater than
six months.
The vaccine was generally well-tolerated by all participants,
with fewer local and systemic reactions as compared with Phase 1/2
data.
ENSEMBLE was initiated in collaboration with the Biomedical
Advanced Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response at
the U.S. Department of Health and Human Services (HHS) under Other
Transaction Agreement HHSO100201700018C, and the National Institute
of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH) at HHS.
Full data will be submitted for publication in the coming
months.
ENSEMBLE 2 Study
The Phase 3 ENSEMBLE 2 study is a
randomized, double-blind, placebo-controlled clinical trial
designed to evaluate the safety and efficacy of a two-dose vaccine
regimen, given at a 56-day interval, versus placebo in adults 18
years old and older with and without comorbidities associated with
an increased risk for severe COVID-19.
The study was designed to assess efficacy of the investigational
vaccine after both the first and second dose to evaluate protection
against the virus and potential incremental benefits for duration
of protection with a second dose. In the ENSEMBLE 2 Phase 3 study
solicited and unsolicited adverse events following this second dose
are similar to those seen in single-dose studies.
Compared to the single-dose results, ENSEMBLE 2 also
demonstrated increased efficacy of a two-dose schedule against
moderate to severe/critical COVID-19 of 75 percent (CI, 55%-87%;
n=14 cases vaccine arm, n=52 cases placebo arm) and severe/critical
COVID-19 of 100 percent (CI, 33%-100%; n=0 cases vaccine arm, n=8
cases placebo arm) at least 14 days following the second
vaccination prior to unblinding. In the U.S., efficacy against
moderate to severe/critical COVID-19 was 94 percent (CI, 58%-100%;
n=1 case vaccine arm, n=14 cases placebo arm).
Median follow-up time in the ENSEMBLE 2 study was 36 days since
second vaccination, with 29 percent of participants having at least
two months of follow-up after receipt of their second dose.
The vaccine, when given as a second dose or booster, remained
generally well-tolerated.
Full data will be submitted for publication in the coming
months.
For more information on the Company's multi-pronged approach to
helping combat the pandemic, visit: www.jnj.com/covid-19.
Authorized Use
The Janssen COVID-19 vaccine is
authorized for use in the U.S. under an Emergency Use Authorization
(EUA) for active immunization to prevent coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus
2 (SARS-CoV-2) in individuals 18 years of age and older.
IMPORTANT SAFETY INFORMATION
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE
YOU GET THE JANSSEN COVID-19 VACCINE?
Tell the vaccination
provider about all of your medical conditions, including if
you:
- have any allergies
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects your
immune system
- are pregnant or plan to become pregnant
- are breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
WHO SHOULD NOT GET THE JANSSEN COVID-19
VACCINE?
You should not get the Janssen COVID-19 Vaccine if
you:
- had a severe allergic reaction to any ingredient of this
vaccine.
HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen
COVID-19 Vaccine will be given to you as an injection into the
muscle. The Janssen COVID-19 Vaccine vaccination schedule is a
single dose.
WHAT ARE THE RISKS OF THE JANSSEN COVID-19
VACCINE?
Side effects that have been reported with the
Janssen COVID-19 Vaccine include:
- Injection site reactions: pain, redness of the skin, and
swelling.
- General side effects: headache, feeling very tired, muscle
aches, nausea, fever.
- Swollen lymph nodes.
- Unusual feeling in the skin (such as tingling or a crawling
feeling) (paresthesia), decreased feeling or sensitivity,
especially in the skin (hypoesthesia).
- Persistent ringing in the ears (tinnitus).
- Diarrhea, vomiting.
Severe Allergic Reactions
There is a remote chance that the Janssen COVID-19 Vaccine could
cause a severe allergic reaction. A severe allergic reaction would
usually occur within a few minutes to one hour after getting a dose
of the Janssen COVID-19 Vaccine. For this reason, your vaccination
provider may ask you to stay at the place where you received your
vaccine for monitoring after vaccination. Signs of a severe
allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
Blood Clots with Low Levels of Platelets
Blood clots involving blood vessels in the brain, lungs, abdomen,
and legs along with low levels of platelets (blood cells that help
your body stop bleeding), have occurred in some people who have
received the Janssen COVID-19 Vaccine. In people who developed
these blood clots and low levels of platelets, symptoms began
approximately one to two-weeks following vaccination. Reporting of
these blood clots and low levels of platelets has been highest in
females ages 18 through 49 years. The chance of having this occur
is remote. You should seek medical attention right away if you have
any of the following symptoms after receiving Janssen COVID-19
Vaccine:
- Shortness of breath,
- Chest pain,
- Leg swelling,
- Persistent abdominal pain,
- Severe or persistent headaches or blurred vision,
- Easy bruising or tiny blood spots under the skin beyond the
site of the injection.
These may not be all the possible side effects of the Janssen
COVID-19 Vaccine. Serious and unexpected effects may occur. The
Janssen COVID-19 Vaccine is still being studied in clinical
trials.
Guillain Barré Syndrome
Guillain Barré syndrome (a neurological disorder in which the
body's immune system damages nerve cells, causing muscle weakness
and sometimes paralysis) has occurred in some people who have
received the Janssen COVID-19 Vaccine. In most of these people,
symptoms began within 42 days following receipt of the Janssen
COVID-19 Vaccine. The chance of having this occur is very low. You
should seek medical attention right away if you develop any of the
following symptoms after receiving the Janssen COVID-19
Vaccine:
- Weakness or tingling sensations, especially in the legs or
arms, that's worsening and spreading to other parts of the
body
- Difficulty walking
- Difficulty with facial movements, including speaking, chewing,
or swallowing
- Double vision or inability to move eyes
- Difficulty with bladder control or bowel function
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience
a severe allergic reaction, call 9-1-1, or go to the nearest
hospital.
Call the vaccination provider or your healthcare provider if you
have any side effects that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse
Event Reporting System (VAERS). The VAERS toll-free number
is 1-800-822-7967 or report online
to https://vaers.hhs.gov/reportevent.html. Please include
"Janssen COVID-19 Vaccine EUA" in the first line of box #18 of the
report form. In addition, you can report side effects to Janssen
Biotech Inc. at 1-800-565-4008.
Please read Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers)
including full EUA Prescribing Information available
at www.JanssenCOVID19Vaccine.com/EUA-factsheet
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.
Cautions 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 a potential preventive vaccine
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 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
January 3, 2021, 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