NEW BRUNSWICK, N.J.,
Oct. 15, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced the U.S. Food and Drug Administration's (FDA) Vaccines
and Related Biological Products Advisory Committee (VRBPAC)
unanimously voted 19-0 to recommend Emergency Use Authorization
(EUA) for a booster dose of the Johnson & Johnson COVID-19
vaccine for adults aged 18 and older at least two months following
initial vaccination with the single-shot vaccine.
The vote was based on findings from two Company clinical trials,
including the Phase 3 ENSEMBLE 2 study, which evaluated a
booster dose of the Johnson & Johnson COVID-19 vaccine
administered two months after the single-shot, as well as a large
and robust real-world evidence study. The Company also presented
data that support the increased potential of a booster when
administered at six months. Phase 3 clinical data and real-world
data both demonstrated the Johnson & Johnson single-shot
COVID-19 vaccine was strong and long-lasting.
"Today's recommendation is based on the totality of evidence,
with clinical and real-world data showing that while a single shot
offers strong and long-lasting protection against COVID-19, a
booster given after the single-dose primary vaccination increases
protection, in particular against symptomatic COVID-19," said
Paul Stoffels, M.D., Vice Chairman
of the Executive Committee and Chief Scientific Officer, Johnson
"Johnson & Johnson is steadfast in its commitment to protect
as many people globally as possible against the continued spread of
COVID-19," said Mathai Mammen, M.D.,
Ph.D., Global Head, Janssen Research & Development, Johnson
& Johnson. "Today's recommendation by the VRBPAC is another
step toward ensuring that those who have received the single-shot
Johnson & Johnson vaccine – or will receive it in the future –
are provided the opportunity to increase their protection against
COVID-19. We look forward to sharing these data with regulatory
bodies and advisory groups around the world to address the
continued threat of COVID-19."
The Company's EUA amendment submission included results from the
Phase 3 ENSEMBLE 2 study, which found a booster dose at two months
provided 94 percent protection against symptomatic (moderate to
severe/critical) COVID-19 in the United
States (CI, 58%-100%) and 100 percent protection (CI,
33%-100%) against severe/critical COVID-19, at least 14 days
post-booster vaccination. Also submitted were findings from a Phase
1/2a study evaluating a booster dose given six months after the
first shot, which show antibody levels increased nine-fold one week
after the booster, and continued to climb to 12-fold higher four
weeks after the booster.
The vaccine, when given as a booster or primary dose, was
generally well-tolerated, with no new safety signals observed in
the two-dose ENSEMBLE 2 trial compared with single-dose
The submission also included data from a large and robust U.S.
real-world evidence study, conducted from March to July 31, 2021, and recently extended to
August 31, 2021. These real-world
data demonstrated the single-dose Johnson & Johnson COVID-19
vaccine showed stable vaccine effectiveness of 76 percent (CI,
75%-77%) for COVID-19-related infections and 81 percent (CI,
79%-84%) for COVID-19-related hospitalizations, with no evidence of
reduced effectiveness over the study duration of six months –
including when the Delta variant became dominant in the U.S.
(sequencing data were not available for analysis).
Johnson & Johnson remains committed to helping end this
pandemic as quickly as possible and is committed to diligently
generating and evaluating real-world evidence, as well as evidence
from its ongoing clinical trial program.
The Company anticipates a decision from the FDA on the EUA
amendment for a booster dose of the Johnson & Johnson COVID-19
vaccine in the coming days, and plans 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. The Centers for Disease Control and Prevention's (CDC)
Advisory Committee on Immunization Practices (ACIP) will discuss
the use of boosters and provide a potential recommendation on
In the U.S., there is sufficient supply to support boosting to
those who have received the more than 15.1 million doses of the
Johnson & Johnson COVID-19 vaccine that have been administered
as primary vaccinations.
The Johnson & Johnson single-shot COVID-19 vaccine,
developed by its Janssen Pharmaceutical Companies of Johnson &
Johnson, received initial 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.
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 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
- 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 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. 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
- Injection site reactions: pain, redness of the skin, and
- 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
- 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.
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 developments.
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SOURCE Johnson & Johnson