NEW BRUNSWICK, N.J.,
Aug. 25, 2021 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) (the Company) today announced data
supporting the use of its COVID-19 vaccine as a booster shot for
people previously vaccinated with the single-shot Johnson &
Johnson vaccine.
In July, the Company reported interim Phase 1/2a data
published in the New England Journal of Medicine that
demonstrated neutralizing antibody responses generated by the
Johnson & Johnson single-shot COVID-19 vaccine were strong and
stable through eight months after immunization.
In anticipation of the potential need for boosters, the Company
conducted two Phase 1/2a studies in individuals previously
vaccinated with its single-shot vaccine. New interim data from
these studies demonstrate that a booster dose of the Johnson &
Johnson COVID-19 vaccine generated a rapid and robust increase in
spike-binding antibodies, nine-fold higher than 28 days after the
primary single-dose vaccination. Significant increases in binding
antibody responses were observed in participants between ages 18
and 55, and in those 65 years and older who received a lower
booster dose. The study summaries were submitted to medRxiv
on August 24.
"We have established that a single shot of our COVID-19 vaccine
generates strong and robust immune responses that are durable and
persistent through eight months. With these new data, we also see
that a booster dose of the Johnson & Johnson COVID-19 vaccine
further increases antibody responses among study participants who
had previously received our vaccine," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen
Research & Development, Johnson & Johnson. "We look forward
to discussing with public health officials a potential strategy for
our Johnson & Johnson COVID-19 vaccine, boosting eight months
or longer after the primary single-dose vaccination."
The Company is engaging with the U.S. Food and Drug
Administration (FDA), U.S. Centers for Disease Control and
Prevention (CDC), European Medicines Agency (EMA) and other health authorities regarding
boosting with the Johnson & Johnson COVID-19 vaccine. Johnson
& Johnson continues to diligently generate and evaluate data
from ongoing trials as well as emerging real-world evidence.
The Phase 1/2a clinical trials (VAC31518COV1001 and
VAC31518COV2001) have been funded in part with federal funds from
the U.S. Department of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response, Biomedical
Advanced Research and Development Authority (BARDA), under other
transaction authority ("OTA") agreement No. HHSO100201700018C.
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
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.
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