NEW BRUNSWICK, N.J.,
Feb. 26, 2021 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) (the Company) today
announced that the U.S. Food and Drug Administration's (FDA)
Vaccines and Related Biological Products Advisory Committee
(VRBPAC) unanimously voted to recommend Emergency Use Authorization
(EUA) for the Company's single-shot COVID-19 vaccine candidate for
adults 18 and older, developed by the Janssen Pharmaceutical
Companies of Johnson & Johnson. The vote was based on a
totality of scientific evidence provided by the Company, including
efficacy and safety data from the Phase 3 ENSEMBLE trial.
"We are extremely grateful to the VRBPAC members for their
extensive review of the data supporting emergency use of Johnson
& Johnson's single-shot COVID-19 vaccine candidate," said
Paul Stoffels, M.D., Vice Chairman
of the Executive Committee and Chief Scientific Officer, Johnson
& Johnson. "We believe our COVID-19 vaccine candidate has the
potential to help change the trajectory of the pandemic and stand
ready to make it available to protect the public as soon as
possible."
The next step in the process is for the FDA to decide whether to
grant an EUA for Janssen's COVID-19 vaccine candidate. The
recommendation of the FDA Advisory Committee is non-binding, and
the final decision on authorization is made by the FDA. Under an
EUA, the FDA has the authority to allow unapproved medical products
or unapproved uses of approved medical products to be used in an
emergency to diagnose, treat, or prevent serious or
life-threatening diseases or conditions during a declared public
health emergency. If authorized by the FDA, the U.S. Centers
for Disease Control and Prevention's (CDC) Advisory Committee on
Immunization Practices (ACIP) will then provide a recommendation on
the use and roll-out of the Janssen COVID-19 vaccine candidate.
"We are grateful to everyone who has contributed to the wealth
of data we presented today, including study participants, site
investigators and teams, collaborators and everyone who has worked
so hard to bring us to this moment. We are confident that our
COVID-19 vaccine candidate will have a significant impact in
protecting people around the world," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen
Research & Development, Johnson & Johnson.
Johnson & Johnson is committed to making its COVID-19
vaccine candidate available on a not-for-profit basis for
emergency pandemic use. The Company is prepared to supply
its vaccine immediately upon EUA and expects to deliver enough
single-dose vaccine candidate 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-dose vaccines to the
U.S. during the first half of 2021.
Johnson & Johnson also recently announced its
submission of a European Conditional Marketing Authorisation
Application to the European Medicines Agency as well as 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.
Manufacturing and Supply Chain Information
The
Johnson & Johnson COVID-19 single-dose vaccine candidate 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.
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% of participants over age 60.
The study enrolled 44% of participants in the United States. Seventy-four percent of
participants in the U.S. are White/Caucasian; 15% are Hispanic
and/or Latinx; 13% are Black/African American; 6% are Asian and 1%
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 Janssen COVID-19
vaccine candidate, including the ENSEMBLE clinical trial and the
delivery of doses for the U.S., have been funded 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).
Janssen 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.
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