NEW BRUNSWICK, N.J.,
Dec. 30, 2021 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) (the Company) today announced new
preliminary results from the South African Phase 3b Sisonke study which showed that a homologous
(same vaccine) booster shot of the Johnson & Johnson COVID-19
vaccine (Ad26.COV2.S) demonstrated 85 percent effectiveness against
COVID-19-related hospitalization. The study, conducted by the South
African Medical Research Council (SAMRC), showed that the Johnson
& Johnson booster reduced the risk of hospitalization from
COVID-19 among healthcare workers in South Africa after Omicron became the dominant
variant. During the months studied (mid-November to mid-December)
the frequency of Omicron increased from 82 to 98 percent of
COVID-19 cases in South Africa as
reported by GISAID, an initiative that provides COVID-19 data.
A second, separate analysis of the immune response to different
vaccine regimens, conducted by Beth Israel Deaconess Medical
Center (BIDMC), demonstrated that a heterologous booster (different
vaccine) of the Johnson & Johnson COVID-19 vaccine in
individuals who initially received the BNT162b2 mRNA vaccine
generated a 41-fold increase in neutralizing antibody responses and
a 5-fold increase in CD8+ T-cells to Omicron by four weeks
following the boost. A homologous boost with BNT162b2
generated a 17-fold increase in neutralizing antibodies and a
1.4-fold increase in CD8+ T-cells by four weeks following the
boost. Both neutralizing antibodies and CD8+ T-cells were higher
four weeks after the boost with the Johnson & Johnson vaccine
than with the BNT162b2 vaccine.
The increase in CD8+ T-cells generated by the Johnson &
Johnson vaccine may be key to explaining the high levels of
effectiveness against severe COVID-19 disease and hospitalization
in the Sisonke 2 study, as the Omicron variant has been shown to
escape neutralizing antibodies.1
"Data from the Sisonke 2 study confirm that the Johnson &
Johnson COVID-19 booster shot provides 85 percent effectiveness
against hospitalization in areas where Omicron is dominant. This
adds to our growing body of evidence which shows that the
effectiveness of the Johnson & Johnson COVID-19 vaccine remains
strong and stable over time, including against circulating variants
such as Omicron and Delta," said Mathai
Mammen, M.D., Ph.D., Global Head, Janssen Research &
Development, LLC, Johnson & Johnson. "We believe that the
protection could be due to the robust T-cell responses induced by
the Johnson & Johnson COVID-19 vaccine. Furthermore, these
data suggest that Omicron is not affecting the T-cell responses
generated by our vaccine."
The data have been submitted to the pre-print server
medRxiv by the studies' authors, with anticipation of
publication in peer-reviewed journals.
Phase 3b Sisonke 2 Booster Shot
Study in South African Healthcare Workers
Data from the
Sisonke 2 trial (n=227,310), conducted among healthcare workers in
South Africa who received the
single-shot Johnson & Johnson COVID-19 vaccine as a primary
dose, show that the Johnson & Johnson COVID-19 booster
increased vaccine effectiveness (VE) against hospitalization to 85
percent. When a booster shot was administered six to nine months
after a primary single dose, VE increased over time from 63 percent
(95% CI, 31-81%) at 0-13 days, to 84 percent (95% CI, 67-92%) at
14-27 days and 85 percent (95% CI, 54-95%) at 1-2 months
Sisonke 2 was conducted in approximately 350 vaccination centers
across all nine provinces of South
Africa. Utilizing data from Discovery Health, a South
African managed care organization, trial investigators determined
VE of the Johnson & Johnson COVID-19 booster shot (n=69,092) as
compared to other individuals enrolled in the same managed care
organization, during the period from November 15, 2021, through December 20, 2021.
Enrollment for the Sisonke 2 arm of the trial commenced just
prior to the onset of the Omicron wave in South Africa, allowing researchers to evaluate
the effectiveness of the Company's COVID-19 vaccine specifically as
Omicron became the dominant variant in the country. Genomic
characterization of isolates from COVID-19 cases was not conducted
in this trial.
Healthcare workers have an increased risk of being infected with
COVID-19, and in countries such as South
Africa, which have a significant population living with
comorbidities, the impacts of SARS-CoV-2 infections in healthcare
workers are especially profound. The majority of South African
healthcare workers who have died of COVID-19 had at least one
comorbidity, and many had multiple comorbidities.
"Even before you factor in the increased infectiousness of
Omicron, we have to remember that healthcare workers on the
frontlines are at a greatly increased risk of being affected by
COVID-19 in the first place," said Glenda
E. Gray, MBBCH, FCPaed (SA), President and CEO of the SAMRC.
"We are therefore encouraged to see that boosting with the Johnson
& Johnson COVID-19 vaccine regimen provides strong protection
in a challenging real-world setting where there is an elevated risk
of exposure – not just to COVID-19, but to the highly transmissible
Dr. Nicholas Crisp, the Deputy
Director General of the South African National Department of Health
said "The data showing the effectiveness of the Ad26.COV.2 vaccine
booster against Omicron in Sisonke is important, as this vaccine is
part of our arsenal to combat COVID-19. This data should reassure
healthcare workers who have not taken their booster to get
vaccinated as soon as possible."
Antibody and T-Cell Responses After Heterologous Boosting
Regimen Greater than After Homologous Regimen Against Omicron
An analysis of 65 individuals who received primary
vaccination with two doses of an mRNA COVID-19 vaccine (BNT162b2),
followed by a homologous booster shot of BNT162b2 (n=24) or a
heterologous booster with the Johnson & Johnson COVID-19
vaccine (n=41) after at least six months, found both regimens
increased humoral and cellular responses against Omicron.
Antibody responses against Omicron were boosted by both the
Johnson & Johnson COVID-19 vaccine and the BNT162b2 vaccine,
with the Johnson & Johnson COVID-19 vaccine increasing
neutralizing antibody titers by 41-fold at four weeks post-boost.
The BNT162b2 vaccine was found to increase antibody titers to a
higher level at week two post-boost, before declining to represent
a 17-fold increase at week four post-boost. The progressive
increase in antibodies the weeks following a vaccination of a
Johnson & Johnson booster is similar to that seen following the
first vaccine. The rapid immune response followed by waning of the
antibody response after the BNT162b2 booster is also similar to
that seen following the two-dose priming regimen.
The Johnson & Johnson COVID-19 vaccine boosted median
Omicron-reactive CD8+ T-cells by 5.5-fold, and Omicron-reactive
CD4+ T-cells by 3.1-fold, while the homologous (BNT162b2) regimen
boosted both Omicron-reactive CD4+ and CD8+ T-cells by
T-cells can target and destroy cells infected by the virus that
causes COVID-19 and are believed to contribute to protection
against severe disease. Specifically, CD8+ T-cells can directly
destroy infected cells and are aided by CD4+ T-cells.
These data suggest that heterologous boosting has the potential
to induce strong cell-mediated immunity, which is important for
immune memory and protection against severe lower respiratory tract
disease. The durability of heterologous and homologous boost
regimens for the SARS-CoV-2 Omicron variant remain to be
"As the Omicron variant has mutated from the original SARS-CoV-2
strain, there is a need to understand how effective currently
authorized COVID-19 vaccines remain at protecting against severe
disease," said Dan Barouch, M.D.,
Ph.D., Director of the Center for Virology and Vaccine Research at
BIDMC. "Our analysis shows that a booster shot of the Johnson &
Johnson COVID-19 vaccine generated a robust increase in both
neutralizing antibodies and T-cells to Omicron."
The Johnson & Johnson
COVID-19 vaccine has been authorized as booster by multiple
regulators and healthcare bodies around the world. Johnson &
Johnson continues to submit relevant 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.
On December 16, 2021, the U.S.
Centers for Disease Control and Prevention (CDC) endorsed updated
recommendations made by the Advisory Committee on Immunization
Practices (ACIP) for the prevention of COVID-19, expressing a
clinical preference for individuals to receive an mRNA COVID-19
vaccine over the Johnson & Johnsons COVID-19 vaccine. In the
U.S., individuals who are unable or unwilling to receive an mRNA
vaccine will continue to have access to the Johnson & Johnson
The Johnson & Johnson COVID-19 vaccine is an important
choice for people who can't or won't return for multiple
vaccinations or who would remain unvaccinated without an
alternative to the mRNA vaccines. The Johnson & Johnson
COVID-19 vaccine aligns with the World Health Organization's (WHO)
recommendations for medical interventions in a pandemic setting,
which emphasize ease of distribution, administration, and
For more information on the Company's multi-pronged approach to
helping combat the pandemic, visit: www.jnj.com/covid-19.
Dr. Dan Barouch and Dr.
Glenda E. Gray are independent study
investigators who have collaborated with Janssen Research &
Development, LLC on clinical trials of the Johnson & Johnson
AUTHORIZATION OF USE
The Johnson & Johnson COVID-19 vaccine, also known as the
Janssen COVID-19 Vaccine, is authorized for use 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).
- Primary vaccination regimen for the Janssen COVID-19 Vaccine is
a single-dose (0.5 mL) administered to individuals 18 years of age
- A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be
administered at least 2 months after the primary vaccination to
individuals 18 years of age and older.
- A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL)
may be administered to individuals 18 years of age and older as a
heterologous booster dose following completion of primary
vaccination with another authorized or approved COVID-19 vaccine.
The dosing interval for the heterologous booster dose is the same
as that authorized for a booster dose of the vaccine used for
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
- 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
You should not get the Janssen COVID-19 Vaccine if you:
- had a severe allergic reaction after a previous dose of this
- had a severe allergic reaction to any ingredient of this
- had a blood clot along with a low level of platelets (blood
cells that help your body stop bleeding) following Janssen COVID-19
Vaccine or following AstraZeneca's COVID-19 vaccine (not authorized
or approved in the United
HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen COVID-19 Vaccine will be given to you as an injection
into the muscle.
Primary Vaccination: The Janssen COVID-19 Vaccine is
administered as a single dose.
- A single booster dose of the Janssen COVID-19 Vaccine may be
administered at least two months after primary vaccination with the
Janssen COVID-19 Vaccine.
- A single booster dose of the Janssen COVID-19 Vaccine may be
administered to individuals 18 years of age and older who have
completed primary vaccination with a different authorized or
approved COVID-19 vaccine. Please check with your health care
provider regarding timing of the booster dose.
WHAT ARE THE RISKS OF THE JANSSEN COVID-19 VACCINE?
Side effects that have been reported with the Janssen COVID-19
- Injection site reactions: pain, redness of the skin, and
- General side effects: headache, feeling very tired, muscle
aches, nausea, fever.
- Swollen lymph nodes.
- Blood clots.
- 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 after vaccination. Blood clots with
low levels of platelets following the Janssen COVID-19 Vaccine have
been reported in males and females, across a wide age range of
individuals 18 years and older; reporting has been highest in
females ages 30 through 49 years (about 1 case for every 100,000
vaccine doses administered), and about 1 out of every 7 cases has
been fatal. You should seek medical attention right away if you
have any of the following symptoms after receiving the Janssen
- 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
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
- Weakness or tingling sensations, especially in the legs or
arms, that's worsening and spreading to other parts of the
- Difficulty walking.
- Difficulty with facial movements, including speaking, chewing,
- 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.
CAN I RECEIVE THE JANSSEN COVID-19 VACCINE AT THE SAME TIME
AS OTHER VACCINES?
Data have not yet been submitted to FDA on administration of the
Janssen COVID-19 Vaccine at the same time as other vaccines. If you
are considering receiving the Janssen COVID-19 Vaccine with other
vaccines, discuss your options with your healthcare provider.
Please read Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers)
including full EUA Prescribing Information available
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 &
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, manufacture and distribution of the Johnson &
Johnson COVID-19 vaccine. 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
subsequently filed Quarterly Reports on Form 10-Q and other 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
1 Planas D., et al. Nature. Considerable escape of
SARS-CoV-2 Omicron to antibody neutralization. Available at:
https://www.nature.com/articles/d41586-021-03827-2. Last accessed:
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SOURCE Johnson & Johnson