NEW BRUNSWICK, N.J.,
Oct. 21, 2021 /PRNewswire/
-- Johnson & Johnson (the Company) (NYSE: JNJ) today
announced that the U.S. Centers for Disease Control and Prevention
(CDC) Advisory Committee on Immunization Practices (ACIP), has
recommended its COVID-19 vaccine as a booster for all eligible
individuals who receive an authorized COVID-19 vaccine.
"Today's recommendation supports the use of the Johnson &
Johnson COVID-19 vaccine as a booster for eligible individuals in
the U.S. regardless of which vaccine they initially receive," said
Paul Stoffels, M.D., Vice Chairman
of the Executive Committee and Chief Scientific Officer at Johnson
& Johnson. "The Johnson & Johnson vaccine provided 94
percent protection in the U.S. against COVID-19 when given as a
booster following the single-shot Johnson & Johnson vaccine,
and due to its unique mechanism of action, offers long-lasting,
durable protection. We remain confident in the benefit it will
provide to millions around the world."
The Johnson & Johnson COVID-19 vaccine was recommended as a
booster for adults aged 18 and older who received the Johnson &
Johnson single-shot vaccine at least two months earlier. A booster
dose of the Johnson & Johnson COVID-19 vaccine was also
recommended for eligible adults at least six months following the
second dose of an authorized mRNA vaccine.
The ACIP recommendation has been forwarded to the Director of
the CDC and the U.S. Department of Health and Human Services (HHS)
for review and adoption.
The Company's single-dose COVID-19 vaccine received FDA
Emergency Use Authorization for adults aged 18 and older
on February 27, 2021. On October 20, 2021, the FDA authorized for
emergency use a booster shot of the Johnson & Johnson COVID-19
vaccine for adults aged 18 and older at least two months following
primary vaccination with the Company's single-dose vaccine.
For more information on the Company's multi-pronged approach to
helping combat the pandemic, visit: www.jnj.com/covid-19.
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) to provide:
- 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 as a heterologous booster dose following
completion of primary vaccination with another authorized or
approved COVID-19 vaccine. The eligible population(s) and dosing
interval for the heterologous booster dose are the same as those
authorized for a booster dose of the vaccine used for primary
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 VACCINE?
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
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 eligible individuals who have completed primary
vaccination with a different authorized or approved COVID-19
vaccine. Please check with your health care provider regarding
eligibility for and 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. 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 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 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
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SOURCE Johnson & Johnson