NEW BRUNSWICK, N.J.,
Dec. 5, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced preliminary results from an independent study, including
a subset of participants from the Janssen-sponsored COV2008 study,
conducted by Dan Barouch, M.D.,
Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC),
which showed that a booster shot of the Johnson & Johnson
COVID-19 vaccine (Ad26.COV2.S), administered at six months after a
two-dose primary regimen of BNT162b2, increased both antibody and
T-cell responses. These results demonstrate the potential benefits
of heterologous boosting (mix-and-match). The article describing
these results have been posted on medRxiv.
"There is early evidence to suggest that a mix-and-match
boosting approach may provide individuals with different immune
responses against COVID-19 than a homologous boosting approach,"
said Dan Barouch, M.D., Ph.D.,
Director of the Center for Virology and Vaccine Research at BIDMC.
"In this preliminary study, when a booster dose of Ad26.COV2.S was
given to individuals six months after a primary regimen with the
BNT162b2 vaccine, there was a comparable increase of antibody
responses at week four following the boost and a greater increase
of CD8+ T-cell responses with Ad26.COV2.S compared with
"These results provide valuable scientific insights for our
vaccine when used as a mix-and-match booster and can help inform
boosting strategies with the goal to curb the pandemic," said
Mathai Mammen, M.D., Ph.D., Global
Head, Janssen Research & Development, Johnson & Johnson.
"These data add to the growing body of evidence demonstrating that
a mix-and-match booster dose of the Johnson & Johnson COVID-19
vaccine successfully increases humoral responses and cellular
responses against the original strain of SARS-CoV-2, as well as the
Beta and Delta variants."
These Phase 2 data are reinforced by preliminary results from
the UK COV-BOOST clinical study published in The Lancet,
which demonstrated that following primary vaccination with two
doses of either BNT162b2 (n=106) or ChAdOx1 nCov-19 (n=108), a
booster dose of the Johnson & Johnson COVID-19 vaccine
increased both antibody and T-cell responses.
Cellular (T-Cell) Responses
In this preliminary study,
boosting with the Johnson & Johnson COVID-19 vaccine after a
primary vaccine regimen of BNT162b2 appears to lead to a greater
increase in CD8+ T-cell responses than boosting with BNT162b2.
These T-cell response data suggest differences between immune
responses following homologous boosting with BNT162b2, and
mix-and-match boosting with the Johnson & Johnson COVID-19
vaccine following a primary regimen of BNT162b2.
The Johnson & Johnson COVID-19 vaccine leverages Janssen's
AdVac® technology and cell-mediated immunity, including
CD4+ and CD8+ responses. T-cells can target and destroy cells
infected by the virus that causes COVID-19. Specifically, CD8+
T-cells can directly destroy infected cells and are aided by CD4+
Humoral (Antibody) Responses
Both the Johnson &
Johnson COVID-19 vaccine and BNT162b2 as boosters led to similar
neutralizing and binding antibody levels against the original
SARS-CoV-2 strain, as well as the Delta and Beta variants, four
weeks following the boost. However, after a mix-and-match booster
dose of the Johnson & Johnson COVID-19 vaccine, antibodies
continued to increase for at least four weeks whereas in
individuals who received a homologous boost with the BNT162b2
vaccine, antibodies declined from week two to week four
Neutralizing antibodies are capable of binding to the virus in a
way that blocks infection and confines the virus to the upper
respiratory tract. Binding antibodies can bind to the virus' spike
protein and inactivate the virus through non-neutralizing antiviral
For this study, a specimen biorepository
at Beth Israel Deaconess Medical Center (BIDMC) obtained samples
from individuals who received the BNT162b2 vaccine. Participants
either continued follow-up in the biorepository and were boosted
with 30 ug BNT162b2 (n=24) or were enrolled in the COV2008 study
(NCT04999111) and were boosted with 5, 2.5, or 1x1010 vp
of the Johnson & Johnson COVID-19 vaccine (n=41). The COV2008
study is a Johnson & Johnson sponsored, ongoing, blinded Phase
2 clinical trial (VAC31518COV2008) to evaluate its COVID-19 vaccine
as a booster in adults 18 years of age and older.
The U.S. Centers for Disease Control and Prevention (CDC)
Advisory Committee on Immunization Practices (ACIP) has recommended
the Johnson & Johnson COVID-19 vaccine as a booster for all
eligible individuals aged 18 years and older who receive an
authorized COVID-19 vaccine.
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
In collaboration with academic groups in South Africa and around the world, the Company
has been evaluating the effectiveness of its COVID-19 vaccine
across variants, now including the new and rapidly spreading
Omicron variant. In addition, the Company is pursuing an
Omicron-specific variant vaccine and will progress it as
For more information on the Company's multi-pronged approach to
helping combat the pandemic, visit: www.jnj.com/covid-19.
The Johnson & Johnson COVID-19
vaccine, also referred to 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
- 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
- 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
- had a severe allergic reaction after a previous dose of this
- had a severe allergic reaction to any ingredient of this
HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
COVID-19 Vaccine will be given to you as an injection into the
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
Side effects that have been reported with the
Janssen COVID-19 Vaccine include:
- 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. 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
- 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
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
Cautions Concerning Forward-Looking
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 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
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SOURCE Johnson & Johnson