NEW BRUNSWICK, N.J.,
Feb. 28, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced that the U.S. Centers for Disease Control and
Prevention's (CDC) Advisory Committee on Immunization Practices
(ACIP) has recommended the first single-shot COVID-19 vaccine,
developed by the Janssen Pharmaceutical Companies of Johnson &
Johnson, for individuals 18 years of age and older under the
Emergency Use Authorization (EUA) issued by the U.S. Food and Drug
Administration (FDA).
"For more than 130 years, Johnson & Johnson has come to the
aid of people during times of crisis, and we believe today's
recommendation from the CDC to begin use of our vaccine as part of
the U.S. national immunization program will add a critical tool in
the fight against COVID-19," said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and
Chief Scientific Officer at Johnson & Johnson. "This
recommendation follows the FDA's decision to grant an Emergency Use
Authorization for our single-shot vaccine, which has the potential
to play a pivotal role in helping to end the COVID-19
pandemic."
ACIP is a body of independent health experts that advises the
CDC on the types of populations and circumstances for which
vaccines should be used. The ACIP recommendation will be 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-shot COVID-19 vaccine received EUA from the
FDA on February 27, 2021.
The terms of the EUA allow use of the vaccine while more data
are gathered. The Company plans to file for a Biologics License
Application (BLA) with the FDA later in 2021.
Johnson & Johnson is committed to making its COVID-19
vaccine available on a not-for-profit basis for emergency pandemic
use. The Company has begun shipping its COVID-19 vaccine
and expects to deliver enough
single-shot vaccines by the end of March to enable the
full vaccination of more than 20 million people in the U.S. The
Company plans to deliver 100 million single-shot vaccines to
the U.S. during the first half of 2021. The U.S. government will
manage allocation and distribution of the vaccine in the U.S.
Johnson & Johnson also recently announced its
submission of a European Conditional Marketing Authorisation
Application to the European Medicines Agency as well as its filing
for an Emergency Use Listing with the World Health Organization for
its COVID-19 vaccine candidate. In addition, rolling submissions
for the single-dose COVID-19 vaccine candidate have been initiated
in several countries worldwide.
Manufacturing and Supply Chain Information
The
Johnson & Johnson COVID-19 single-dose vaccine is compatible
with standard vaccine storage and distribution channels with ease
of delivery to remote areas. The vaccine is estimated to remain
stable for two years at -4°F (-20°C), and a maximum of three months
at routine refrigeration at temperatures of 36-46°F (2 to 8°C). The
Company will ship the vaccine using the same cold chain
technologies it uses today to transport treatments for cancer,
immunological disorders and other medicines. The COVID-19 vaccine
should not be re-frozen if distributed at temperatures of 36°F–46°F
(2°-8°C).
Johnson & Johnson's COVID-19 Vaccine
Candidate
The Company's Janssen COVID-19 vaccine
leverages the AdVac® vaccine platform, a unique and
proprietary technology that was also used to develop and
manufacture Janssen's European Commission-approved Ebola vaccine
regimen and construct its investigational Zika, RSV, and HIV
vaccines.
The Janssen COVID-19 vaccine has not been approved or licensed
by the U.S. Food and Drug Administration (FDA), but has been
authorized by the FDA through an Emergency Use Authorization
(EUA).
The FDA EUA Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) and full EUA Prescribing
Information are available here.
For more information on the single-dose Janssen COVID-19
vaccine, visit: www.janssencovid19vaccine.com.
Phase 3 ENSEMBLE Study Design
The Phase 3 ENSEMBLE
study is a randomized, double-blind, placebo-controlled clinical
trial in individuals 18 years of age and older. The study was
designed to evaluate the safety and efficacy of the Company's
vaccine candidate in protecting against both moderate and severe
COVID-19 disease, with assessment of efficacy as of day 14 and
as of day 28 as co-primary endpoints. The study enrolled a total of
43,783 participants.
The trial, conducted in eight countries across three continents,
includes a diverse and broad population including 34 percent of
participants over age 60.
The study enrolled 44 percent of participants in the United States. Seventy-four percent of
participants in the U.S. are White/Caucasian; 15 percent are
Hispanic and/or Latinx; 13 percent are Black/African American; 6
percent are Asian and 1 percent are Native American.
Forty-one percent of participants in the study had comorbidities
associated with an increased risk for progression to severe
COVID-19.
Research and development activities for the Company's COVID-19
vaccine, including the ENSEMBLE clinical trial and the delivery of
doses for the U.S., 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 Contract
No. HHSO100201700018C, and in collaboration with the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH) at the U.S. Department of
Health and Human Services (HHS).
Johnson & Johnson has worked with BARDA since 2015 on
innovative solutions for influenza, chemical, biological, radiation
and nuclear threats and emerging infectious diseases such as
Ebola.
For more information on the Company's multi-pronged approach to
helping combat the pandemic, visit: www.jnj.com/coronavirus.
Authorized Use
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) 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.
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
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.
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.
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