ANTWERP, Belgium, Sept. 12, 2016 /PRNewswire/ -- Johnson &
Johnson (NYSE: JNJ) announced today that Janssen Vaccines &
Prevention B.V. (Janssen) has completed a submission to the World
Health Organization (WHO) for Emergency Use Assessment and Listing
(EUAL) for its investigational preventive Ebola prime-boost vaccine
regimen. The EUAL is a special procedure that can be
implemented when there is an outbreak of a disease with high rates
of morbidity or mortality and a lack of treatment or prevention
options.
"Over the past four decades, we have seen 25 Ebola outbreaks,
with the most recent in West
Africa killing seven times more people than all previous
outbreaks combined," said Paul
Stoffels, M.D., Chief Scientific Officer, Johnson &
Johnson. "We must take action now so that a tragedy on the
scale of West Africa never happens
again. Having an Ebola vaccine available is critical for
global preparedness. If the WHO grants an emergency use listing,
this will accelerate the availability of Janssen's investigational
vaccine regimen to the international community in the event another
Ebola crisis occurs."
EUAL assists UN Member States and procurement agencies determine
the acceptability for use of a specific vaccine in a public health
emergency. The decision to grant EUAL to the investigational
preventative vaccine regimen will be based on an evaluation of
available data including quality, safety, and immunogenicity, as
well as a risk/benefit analysis. While EUAL potentially
allows for deployment of a vaccine in an emergency, the vaccine
remains investigational pending formal regulatory agency review and
approval.
The news coincides with the opening of the 8th
International Symposium on Filoviruses in Antwerp, Belgium, hosted by the Antwerp
Institute of Tropical Medicine, which is reviewing global progress
against Ebola. The first outbreak of the disease was reported
exactly 40 years ago, in September
1976 in Zaire (now the
Democratic Republic of the
Congo).
"Forty years after Ebola's discovery, the potential availability
of a durable prime-boost vaccine would be a tremendous achievement
in global health," said Johan Van
Hoof, M.D., Global Therapeutic Area Head, Infectious
Diseases and Vaccines, Janssen Pharmaceutical Companies, and a
keynote speaker at the 8th International Symposium on
Filoviruses. "If listed for emergency use, the investigational
Janssen vaccine regimen could be a vital prevention tool for rapid
outbreak response, particularly for health workers and vulnerable
communities on the frontlines."
Prime-boost vaccination is an established prevention approach
for several infectious diseases. It involves giving an initial dose
to prime the immune system, followed by a booster dose at a later
date with the goal of potentially strengthening and optimizing the
duration of immunity. Janssen's heterologous prime-boost vaccine
regimen contains two components based on AdVac® technology from
Janssen, and MVA-BN® technology from Bavarian Nordic A/S.
The first clinical data for the investigational Janssen vaccine
regimen among healthy volunteers were published in JAMA:
The Journal of the American Medical Association in
April 2016. The Phase 1 results from
a UK study suggested that the regimen was well-tolerated and
immunogenic (produced an immune response). The study found that 100
percent of study participants achieved an initial antibody response
to Ebola, and that this was sustained eight months following
vaccination among all volunteers.
The UK study provided the first set of data from a total of 10
clinical studies that are being conducted on a parallel track
across the U.S., Europe and
Africa in support of potential
full licensure for a Janssen Ebola vaccine regimen. The first study
of the vaccine regimen in a West African country affected by the
Ebola epidemic began in Sierra
Leone in October 2015.
Janssen is also preparing to initiate a first-in-human Phase 1
clinical study to test a second-generation, multivalent version of
the AdVac/MVA-BN vaccine regimen. The multivalent heterologous
prime-boost regimen is intended to protect against multiple
filoviruses that cause disease in humans, including the Ebola,
Sudan and Marburg viruses. The
U.S. study will test the safety, tolerability and immunogenicity of
this vaccine regimen in varying dosing schedules among healthy
volunteers. The National Institute of Allergy and Infectious
Diseases (NIAID), part of the U.S. National Institutes of Health
(NIH), is funding this study. More information can be found at
ClinicalTrials.gov.
About Janssen's Ebola Vaccine Regimens
Janssen has
made a substantial investment to support the development of its
investigational monovalent Ebola vaccine regimen and multivalent
Ebola, Sudan and Marburg vaccine
regimen. We are also grateful for the significant support and
funding contributed by our global partners to help accelerate the
development of these vaccine regimens.
The monovalent and multivalent vaccine regimens originate from a
collaborative research program with the National Institutes of
Health (NIH) that commenced in 2008. The program has been funded in
part with Federal funds and preclinical services from the National
Institute of Allergy and Infectious Diseases (NIAID), part of NIH,
under Contract Numbers HHSN272200800056C, and HHSN272201000006I and
HHSN272201200003I, respectively. The MVA-BN-Filo material used in
Phase 1 studies was produced under NIAID/Fisher BioServices
contract #FBS-004-009 and NIH contract HHSN272200800044C.
In January 2015, Europe's Innovative Medicines Initiative (IMI)
awarded consortia of leading global research institutions and
non-government organizations working in conjunction with the
Janssen Pharmaceutical Companies grants totaling more than €100
million from the Ebola+ programme to support the development,
manufacturing and deployment of the monovalent Ebola vaccine
regimen. The IMI2 Joint Undertaking receives support from the
European Union's Horizon 2020 research and innovation programme and
European Federation of Pharmaceutical Industries and Associations
(EFPIA).
In September 2015, Janssen
Vaccines & Prevention B.V. was awarded $28.5 million from The Biomedical Advanced
Research and Development Authority (BARDA), part of the U.S.
Department of Health and Human Services, to help accelerate the
development of the monovalent Ebola vaccine regimen under Contract
Number HHSO100201500008C.
Janssen in partnership with Bavarian Nordic rapidly scaled up
production of the monovalent Ebola vaccine regimen and now has
approximately 2,000,000 regimens available, with the capacity to
produce several million regimens if needed.
About Johnson & Johnson
Caring for the world, one person at a time, inspires and unites the
people of Johnson & Johnson. We embrace research and science -
bringing innovative ideas, products and services to advance the
health and well-being of people. Our approximately 127,100
employees at more than 250 Johnson & Johnson operating
companies work with partners in health care to touch the lives of
over a billion people every day, throughout the world.
Our Commitment to Global Public Health
For 130 years, Johnson & Johnson has been committed to
improving the health of individuals, families and communities
around the world, including the most vulnerable populations. Today,
our vibrant, entrepreneurial and committed employees bring business
acumen and their collaborative spirit to help solve some of the
most complex global health problems. By harnessing our collective
breadth and scale, and our employees' passion and purpose, we
strive to advance health care and positively impact the lives of
all people.
About the Janssen Pharmaceutical Companies
At the
Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives
by finding new and better ways to prevent, intercept, treat and
cure disease inspires us. We bring together the best minds and
pursue the most promising science. We are Janssen. We collaborate
with the world for the health of everyone in it. 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, including
regarding development and production capacity of an Ebola vaccine
regimen. 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 development,
including the uncertainties of clinical success and regulatory
approvals; technological advances and new products attained by
competitors; the challenges and risks involved in large-scale
production of a vaccine; and the uncertainty of the level of demand
for a vaccine against Ebola. A further list and description 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, 2016, including
in Exhibit 99 thereto, 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
or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
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