NEW BRUNSWICK, N.J.,
Feb. 27, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company)
today announced that the U.S. Food and Drug Administration (FDA)
has issued Emergency Use Authorization (EUA) for its single-dose
COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies
of Johnson & Johnson, to prevent COVID-19 in individuals
18 years of age and older.
This decision was based on the totality of scientific evidence,
including data from the Phase 3 ENSEMBLE study that
demonstrated the vaccine was 85 percent effective in
preventing severe disease across all regions studied, and showed
protection against COVID-19 related hospitalization and death,
beginning 28 days after vaccination.
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.
"This milestone follows a year of incredible work by our
dedicated teams and unprecedented collaboration with health leaders
around the world – all of whom shared a goal of bringing a
single-shot vaccine to the public," said Alex Gorsky, Chairman and Chief Executive
Officer at Johnson & Johnson. "We will do everything we can to
help bring this pandemic to an end, in the United States and throughout the
world."
"We believe the Johnson & Johnson single-shot COVID-19
vaccine is a critical tool for fighting this global pandemic,
particularly as it shows protection across countries with different
variants. A vaccine that protects against COVID-19, especially
against the most dire outcomes of hospitalization and death, will
help ease the burden on people and the strain on health systems
worldwide," said Paul Stoffels,
M.D., Vice Chairman of the Executive Committee and Chief Scientific
Officer, Johnson & Johnson. "We look forward to our continued
efforts around the world as we collectively aim to change the
trajectory of this global pandemic."
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 vaccines to the
U.S. government 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. This will be prioritized according to the
populations identified by the CDC's Advisory Committee on
Immunization Practices (ACIP) guidelines.
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 (EUL) 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.
The EUA follows a unanimous vote by the U.S. FDA's Vaccines and
Related Biological Products Advisory Committee (VRBPAC), on
February 26, 2021.
"We are thankful for the efforts of all those who have
volunteered to participate in our clinical trials, our
scientists, collaborators, clinical trial sites and
investigators. Through the combined commitment of everyone
involved, we have been able to discover, develop and
manufacture a single-shot COVID-19 vaccine to protect
people around the world," said Mathai
Mammen, M.D., Ph.D., Global Head, Janssen Research &
Development, Johnson & Johnson.
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
The Company's 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 FDA through an Emergency Use Authorization (EUA) for
active immunization to prevent Coronavirus Disease 2019 (COVID-19)
in individuals 18 years of age and older. There is no FDA-approved
vaccine to prevent COVID-19.
The FDA EUA Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) and full EUA
Prescribing Information available are at
https://www.janssenlabels.com/emergency-use-authorization/Janssen+COVID-19+Vaccine-HCP-fact-sheet.pdf.
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