Up to 200,000 Johnson & Johnson Ebola vaccine
regimens will be made available as part of a WHO early access
clinical program now underway in Sierra
Leone
Company's Ebola vaccine regimen also receives
Prequalification from the WHO
The Johnson & Johnson vaccine regimen is designed to be
used proactively to induce immunity against Ebola in adults and
children
NEW BRUNSWICK, N.J.,
May 13, 2021 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) (the Company) today announced the World
Health Organization (WHO) and the government of Sierra Leone have begun administering the
Company's Ebola vaccine regimen as part of a WHO early access
clinical program aimed at preventing further spread of Ebola in
West Africa. The vaccine regimen,
developed by the Janssen Pharmaceutical Companies of Johnson &
Johnson (Janssen) in collaboration
with Bavarian Nordic A/S, is being donated to the WHO by Janssen
for the purposes of the early access clinical program. Johnson
& Johnson also announced that its Ebola vaccine regimen has
received Prequalification from the WHO, which will help accelerate
its registration in countries where Ebola is a persistent public
health threat and facilitate broader access to people at risk of
exposure to this virus.
Health authorities in Guinea
officially declared a new Ebola outbreak in February 2021 after the West African country
experienced its first cases of disease since the end of the
2014-2016 Ebola outbreak – which was the worst on record.
Preliminary data obtained through genetic sequencing suggest that
the new outbreak was caused by the same virus strain also
responsible for the 2014-2016 outbreak and was likely reintroduced
by a survivor. The continuation of the outbreak, which has caused
at least 23 cases and 12 deaths, and the persistence of Ebola virus
in human and animal hosts underscores the importance of proactive
vaccination efforts to prevent the further spread of the virus and
to be prepared for potential new outbreaks in the future.
"Johnson & Johnson's vision is to help prevent Ebola
outbreaks before they start. WHO Prequalification of our vaccine
regimen and the deployment to West
Africa are important steps forward in reaching this goal and
an important milestone for epidemic preparedness," said
Paul Stoffels, M.D., Vice Chairman
of the Executive Committee and Chief Scientific Officer of Johnson
& Johnson. "By working closely with the WHO and national
governments, we will be able to quickly support efforts to protect
populations at risk and help end this latest outbreak. This
proactive approach is essential if we are to solve the growing
threat of infectious diseases, including Ebola."
Johnson & Johnson is grateful to its global strategic
partners who have helped to support and co-fund the Ebola vaccine
regimen, including Bavarian Nordic A/S, the Biomedical Advanced
Research and Development Authority (BARDA) and the National
Institutes of Health (NIH) at the U.S. Department of Health and
Human Services (HHS), and the Innovative Medicines Initiative (IMI)
funded through the EU Horizon 2020 program.
WHO Early Access Clinical Program
Administration of the Johnson & Johnson Ebola vaccine regimen
in West Africa will be directed by
the WHO and national governments in accordance with the protocol
for the early access clinical program, which incorporates interim
2019 recommendations from the WHO's Strategic Advisory Group
of Experts on Immunization (SAGE). The goal of the initiative is to
establish a protective geographic barrier against the spread of
Ebola beyond Guinea, beginning in
the neighboring nation of Sierra
Leone. The program administered its first doses of the
Johnson & Johnson Ebola vaccine regimen this week in
Sierra Leone's Kambia District,
and is expected to expand to additional countries in the region as
local preparations are completed.
The early access clinical program plans to administer the
vaccine to up to 200,000 individuals beginning with health workers,
other frontline workers and others at increased risk
of exposure to the Ebola virus (adults and adolescents 14
years and above on a case-by-case basis or depending on national
regulations). Pregnant women and HIV-positive adults who are
otherwise healthy are permitted to enroll in the program.
Sierra Leone has prior
experience administering the Johnson & Johnson Ebola vaccine.
In 2015, during the West African epidemic, the country's Ministry
of Health and the College of Medicine and Allied Health Sciences
(COMAHS) at the University of Sierra
Leone collaborated with Johnson & Johnson on the first
clinical study of the vaccine in an Ebola-affected country
("EBOVAC-Salone"), which took place in Sierra Leone's Kambia district.
"We are moving with urgency and purpose to bring all of our
available resources to help prevent the spread of this latest Ebola
outbreak in Guinea," said
Ruxandra Draghia-Akli, M.D., Ph.D.,
Global Head, Global Public Health Research & Development,
Johnson & Johnson. "We believe that, through the preventive use
of Ebola vaccines, the global health community can help protect
vulnerable communities living under the threat of this
disease."
WHO Prequalification
The Johnson & Johnson Ebola
vaccine regimen, Zabdeno® (Ad26.ZEBOV) and
Mvabea® (MVA-BN-Filo), was granted WHO Prequalification
in April 2021. This follows Marketing
Authorisation for the vaccine which was granted by the
European Commission in July 2020 for
the active immunization for the prevention of Ebola Virus Disease
caused by the Zaire
ebolavirus species in individuals aged one year and above.
Both WHO Prequalification and the European Commission authorization
were supported by a multi-country clinical program, including 15
clinical studies sponsored by Janssen across three continents.
Discussions are ongoing with the U.S. Food and Drug Administration
regarding the approval of the vaccine regimen in the U.S.
WHO Prequalification is often a prerequisite for national
registrations of new vaccines and medicines in developing
countries. Johnson & Johnson now looks forward to collaborating
with the WHO's African Vaccine Regulatory Forum (AVAREF) to
progress national registrations of the Company's Ebola vaccine
regimen. The Company's Ebola vaccine regimen is designed to be used
proactively to induce immunity against Ebola virus disease in
adults and children.
Johnson & Johnson's Commitment to Ebola & Pandemic
Preparedness
Johnson & Johnson is one of the few
innovative healthcare companies in the world today that is actively
advancing science across multiple disease areas with the aim of
strengthening public health.
We accelerated the development of our Ebola vaccine regimen in
2014 in response to the worst Ebola outbreak on record, which took
place in West Africa from
2014-2016 and caused more than 11,000 deaths. In 2019, in response
to the second-worst outbreak which took place 2018-2020 in the
Democratic Republic of the Congo
(DRC), Johnson & Johnson announced it would provide its Ebola
vaccine regimen to assist immunization efforts in the affected
region and in neighboring Rwanda through the UMURINZI vaccination
campaign. This marked the first widespread deployment of Ebola
vaccines in an outbreak setting.
The Rwandan Ministry of Health continues to administer the
vaccine regimen through the UMURINZI campaign, which recently
achieved the milestone of reaching 200,000 individuals who are at
risk of exposure to Ebola. To date, more than 225,000 individuals
participating in clinical trials and vaccination initiatives have
received at least the first dose of the Johnson & Johnson Ebola
vaccine regimen, including 180,000 who have been fully
vaccinated.
Johnson & Johnson Ebola Vaccine Regimen
The European Commission-approved Johnson & Johnson preventive
Ebola vaccine regimen, Zabdeno® (Ad26.ZEBOV) and
Mvabea® (MVA-BN-Filo), utilizes a non-replicating viral
vector strategy in which viruses – in this case adenovirus serotype
26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are
genetically modified so that they cannot replicate in human cells.
In addition, these vectors carry the genetic code of several Ebola
virus proteins in order to trigger an immune response. The Ebola
vaccine regimen was developed and is manufactured using Janssen's
proprietary AdVac® technology.
Johnson & Johnson's Ebola vaccine regimen originates from a
collaborative research program with the NIH and received direct
funding and preclinical services from the National Institute of
Allergy and Infectious Diseases, part of NIH, under Contract Number
HHSN272200800056C. Further funding for the Ebola vaccine regimen
has been provided in part with federal funds from the Office of the
Assistant Secretary for Preparedness and Response, BARDA under
Contract Numbers HHSO100201700013C and HHSO100201500008C.
The IMI provided funding through the IMI Ebola+ Programme to
support a number of consortia that initiated multiple clinical
trials and other vaccine development activities. The consortia
funded by the Innovative Medicines Initiative 2 (IMI2) Joint
Undertaking are EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr.
115861), EBOVAC3 (grant nr. 800176), EBOMAN (grant nr. 115850) and
EBODAC (grant nr. 115847). This Joint Undertaking receives support
from the EU's Horizon 2020 Framework Programme for Research and
Innovation and the European Federation of Pharmaceutical Industries
and Associations (EFPIA).
Johnson & Johnson also acknowledges its many strategic
partners in the ongoing global clinical program for the vaccine
regimen, including Bavarian Nordic A/S, Centre Muraz, Coalition for
Epidemic Preparedness Innovations (CEPI), College of Medicine and
Allied Health Sciences (COMAHS, University of Sierra Leone), Democratic Republic of the
Congo Ministry of Public Health, Republic of Rwanda Ministry of
Health and Rwanda Biomedical Center, Emory
University's Project San Francisco (Kigali) / Center for Family Health Research,
Emory University, Epicentre, Grameen
Foundation, Inserm, Inserm Transfert, Institut National de Recherce
Biomédicale (INRB), London School of Hygiene & Tropical
Medicine (LSHTM), Médecins Sans Frontières (MSF), Rinda Ubuzima,
Sierra Leone Ministry of Health and Sanitation, Uganda Virus
Research Institute (UVRI), Université de Kinshasa (UNIKIN), University of Antwerp, University of
Oxford, Walter Reed Army Institute of Research (WRAIR),
World Health Organization, World Vision Ireland, Wellcome Trust,
Vibalogics, and all the people who have participated in the Ebola
vaccine clinical trials.
Learn more at www.JNJ.com/Ebola.
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 a program related to the
Johnson & Johnson 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 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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