NEW BRUNSWICK, N.J.,
Dec. 8, 2019 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) today announced that its Janssen
Pharmaceutical Companies will provide up to 200,000 Ebola vaccine
regimens to the Republic of Rwanda. This commitment will support a new
immunization program led by the Rwanda Government that aims to help
protect the country's citizens from the Ebola outbreak in
neighboring Democratic Republic of the
Congo (DRC). The first batches of Janssen vaccine have been
delivered to the country, and further shipments are being
organized.
On July 17, 2019, the World Health
Organization (WHO) declared the DRC Ebola outbreak a Public Health
Emergency of International Concern (PHEIC). More than 3,300 cases,
including more than 2,200 deaths, have been reported to date,
making the outbreak second only to the 2014-2016 West Africa epidemic, and raising concerns
about its potential to cross international borders. In October, the
Johnson & Johnson announced that the DRC would begin using the
Janssen investigational vaccine as part of an expanded response to
the outbreak.
"Johnson & Johnson recognizes the Rwandan Government's
decision to proactively deploy Janssen's investigational Ebola
vaccine to help prevent the spread of the disease into the
country," said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and
Chief Scientific Officer of Johnson & Johnson. "We stand
ready to support Rwanda's
initiative on epidemic preparedness."
WHO's Strategic Advisory Group of Experts (SAGE) on
Immunization recommended in May
2019 that Janssen's investigational Ebola vaccine regimen be
evaluated as part of expanded efforts to contain the DRC outbreak.
Additionally, WHO's Emergency Committee stated, "At-risk countries
should put in place approvals for investigational medicines and
vaccines as an immediate priority for preparedness."
Dr. Diane Gashumba, Rwanda
Minister of Health, said, "Following various trials of the
Ebola vaccine in different countries, and the World Health
Organization's Strategic Advisory Group of Experts'
recommendations, the Rwanda Food and Drug Authority have reviewed
the trials made about this vaccine around the world and it has been
approved that the Janssen vaccine is safe and that it can be given
as a preventive measure. Therefore, Rwanda FDA granted conditional
approval under exceptional emergency for Janssen's Ebola vaccine
regimen."
Dr. Gashumba continued, "We are thankful to Johnson &
Johnson who demonstrated commitment as a global partner to improve
the health of our people by providing the Ebola vaccine that we are
going to use during this voluntary Ebola vaccination campaign, and
we acknowledge Wellcome Trust and the UK Department for
International Development (DFID) for participating in the funding
of the Umurinzi Program."
To date, nearly 8,000 volunteers across the U.S., Europe and Africa have participated in multiple clinical
studies of the Janssen vaccine. This includes approximately 1,300
individuals who have received the Janssen vaccine in the DRC
according to the country's Ebola response committee. The two-dose
regimen includes Ad26.ZEBOV as the first dose, which is based on
Janssen's AdVac® technology, and MVA-BN-Filo as the
second dose, which is based on Bavarian Nordic's MVA-BN®
technology and is administered approximately eight weeks later.
Study results indicate that the vaccine is well tolerated and
induces robust and durable immune responses to the Ebola virus
Zaire strain – the cause of the
DRC outbreak.
Johnson & Johnson has made a significant investment in
Janssen's Ebola vaccine regimen since its decision to accelerate
the development program in 2014 in response to the widespread
outbreak that occurred in West
Africa that year. The vaccine regimen was developed in
collaboration with global partners, including Bavarian Nordic A/S,
the Biomedical Advanced Research and Development Authority (BARDA),
part of the Office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services (HHS),
the Innovative Medicines Initiative (IMI) funded through the EU
Horizon 2020 programme, and the National Institutes of Health (NIH)
at HHS.
About the Rwandan Initiative
Fears for further spread
of Ebola heightened when a case of the disease was reported in
July 2019 in the DRC City of Goma,
which is home to two million people and is a major trading hub
located near the Rwandan border. A significant number of Rwandan
citizens cross the border with the DRC on a regular basis as part
of work, school or family commitments. Following an evaluation of
the situation, the Rwanda Ministry of Health has decided to use
Janssen's vaccine regimen in the border zones, with the objective
of creating a protective barrier to prevent Ebola from impacting
its citizens and from spreading further.
The new vaccination program is called Umurinzi, which locally
refers to the Umurinzi tree which means "guardian" in Kinyarwanda,
an official language of Rwanda.
The program will include a large-scale vaccination campaign
involving approximately 200,000 Rwandans ages two years and older
in regions bordering the DRC judged to be at-risk. In parallel, an
immunogenicity study and a clinical study in pregnant women are
being discussed.
"This is a crucial step forward. Trials to date suggest that the
Janssen vaccine produces a good immune response against Ebola,"
said Dr Jeremy Farrar, Director
of Wellcome. "The new Rwanda
initiative aims to leverage this potential new prevention tool with
the goal of preventing Ebola and building our knowledge on how best
the vaccine can be used to complement wider public health
responses."
The Umurinzi Ebola Vaccine Program immunization campaign is
being planned by the Rwanda Ministry of Health and its Rwanda
Biomedical Center, who will work with local partners such as
Emory University's Project San
Francisco in Kigali to implement
the program together with Rinda Ubuzima. Johnson & Johnson's
Global Public Health division is helping to support community
engagement and health system capacity for Umurinzi through its work
in the EBODAC (Ebola Vaccine Deployment, Acceptance and Compliance)
consortium, which is funded by the Innovative Medicines Initiative
(IMI) and also includes the London School of Hygiene & Tropical
Medicine (LSHTM), World Vision and Grameen Foundation. Innovative
iris scanning technology and automated phone reminders will help
track the uptake and impact of the Janssen vaccine while a mobile
training platform will reinforce key Ebola messages for the
community health worker population.
About Janssen's Ebola Vaccine Regimen
The
Janssen vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) consists of two
doses leveraging different vaccines. The goal of this approach is
to induce robust and long-lasting immunity. The regimen utilizes a
viral vector strategy in which viruses – in this case adenovirus
serotype 26 (Ad26) and Modified Vaccinia Ankara (MVA) – are
genetically modified so that they cannot replicate in human cells,
while safely inducing the production of Ebola virus proteins in
order to trigger an immune response. Janssen-sponsored Phase 1
studies of the Ebola vaccine regimen have been reported in
peer-reviewed journals including JAMA: The Journal of the
American Medical Association1,2 and the
Journal of Infectious Diseases3,4, and Phase 1, 2
and 3 data were recently presented at the 2019 European Congress of
Clinical Microbiology & Infectious Disease
(ECCMID)5–7.
Janssen's investigational Ebola vaccine regimen was developed in
a collaborative research program with the NIH and received direct
funding and preclinical services from the National Institute of
Allergy and Infectious Diseases (NIAID), part of NIH, under
Contract Numbers HHSN272200800056C and HHSN272201200003I,
respectively. 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+ Program 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 partners in the
ongoing global clinical program for the vaccine regimen, including
Bavarian Nordic A/S, Centre Muraz, College of Medicine and Allied
Health Sciences (COMAHS, University of Sierra Leone), Grameen Foundation, Inserm,
Inserm Transfert, London School of Hygiene & Tropical Medicine
(LSHTM), Uganda Virus Research Institute (UVRI), University of
Antwerp, University of Oxford, Vibalogics GmbH, Walter Reed
Army Institute of Research (WRAIR) and World Vision Ireland.
Our Commitment to Pandemic Preparedness &
Response
Today's announcement further demonstrates Johnson
& Johnson's ongoing commitment to global pandemic preparedness
efforts. We are one of the few innovative healthcare companies in
the world today that is actively engaged across multiple disease
areas that are central to this challenge. Through our Janssen
Pharmaceutical Companies, we are actively engaged in developing new
vaccines and/or treatments to combat a wide range of infectious
diseases that are already pandemics, such as HIV, tuberculosis and
hepatitis B, or that have pandemic potential, including Ebola,
Zika, and influenza.
About the Janssen Pharmaceutical Companies
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.
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.
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
collaboration to advance development of an investigational 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: the potential that the expected benefits and opportunities
related to the collaboration may not be realized or may take longer
to realize than expected; challenges inherent in new product
development, including the uncertainty of clinical success,
obtaining regulatory approvals and of the overall timeline for the
availability of a potential vaccine against Ebola; competition,
including technological advances, new products and patents attained
by competitors; uncertainty of commercial success for new products;
the ability of the company to successfully execute strategic plans;
impact of business combinations; manufacturing difficulties and
delays; challenges to patents; changes in behavior and spending
patterns or financial distress of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; trends toward health care
cost containment and the uncertainty of the level of demand for a
vaccine against Ebola. 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 December 30, 2018, 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. Neither 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.
References:
1. Winslow RL, Milligan ID, Voysey M, et al. Immune Responses to
Novel Adenovirus Type 26 and Modified Vaccinia Virus
Ankara–Vectored Ebola Vaccines at 1 Year. JAMA.
2017;317(10):1075. doi:10.1001/jama.2016.20644.
2. Milligan ID, Gibani MM, Sewell R, et al. Safety and
Immunogenicity of Novel Adenovirus Type 26– and Modified Vaccinia
Ankara–Vectored Ebola Vaccines. JAMA. 2016;315(15):1610.
doi:10.1001/jama.2016.4218.
3. Anywaine Z, Whitworth H, Kaleebu P, et al. Safety and
Immunogenicity of a 2-Dose Heterologous Vaccination Regimen With
Ad26.ZEBOV and MVA-BN-Filo Ebola Vaccines: 12-Month Data From a
Phase 1 Randomized Clinical Trial in Uganda and Tanzania. J Infect Dis. February 2019. doi:10.1093/infdis/jiz070.
4. Mutua G, Anzala O, Luhn K, et al. Safety and Immunogenicity of a
2-Dose Heterologous Vaccine Regimen With Ad26.ZEBOV and MVA-BN-Filo
Ebola Vaccines: 12-Month Data From a Phase 1 Randomized Clinical
Trial in Nairobi, Kenya. J
Infect Dis. February 2019.
doi:10.1093/infdis/jiz071
5. Rodolphe Thiebaut, Matthew D
Snape, Neil Goldstein, Cynthia Robinson, Auguste Gaddah, Viki Bockstal,
Odile Launay, Jean-Daniel Lelievre, Laura Richert, Christine
Betard, Andrew Pollard,
Malick Gibani, Elizabeth Clutterbuck, Maarten Leyssen,
Kerstin Luhn, Macaya Douoguih.
Safety and immunogenicity of 2-dose Ebola vaccine regimen with
Ad26.ZEBOV and MVA-BN-Filo in a phase II clinical trial in
Europe (EBOVAC2) - ECCMID Live.
https://www.eccmidlive.org/#!resources/safety-and-immunogenicity-of-2-dose-ebola-vaccine-regimen-with-ad26-zebov-and-mva-bn-filo-in-a-phase-ii-clinical-trial-in-europe-ebovac2-462543af-682f-4031-ae04-4fb46580f2c2.
6. Bailah Leigh, David Ishola,
Daniela Manno, Kwanbena Owusi-Kyei,
Muhammed Afolabi, Frank Baiden, Neil
Goldstein, Cynthia Robinson,
Mohamed Samai, Auguste Gaddah, Viki
Bockstal, Ken Awuondo, Brett Lowe,
Brian Greenwood, Maarten Leyssen,
Deborah Watson-Jones, Macaya
Douoguih. Safety and immunogenicity of a 2-dose Ebola vaccine
regimen with Ad26.ZEBOV and MVA-BN-Filo in a Phase III clinical
trial in Sierra Leone - ECCMID
Live.
https://www.eccmidlive.org/#!resources/safety-and-immunogenicity-of-a-2-dose-ebola-vaccine-regimen-with-ad26-zebov-and-mva-bn-filo-in-a-phase-iii-clinical-trial-in-sierra-leone-99d83beb-79d2-423a-8e16-b648d9fdb059.
7. Neil Goldstein, Viki Bockstal,
Cynthia Robinson, Auguste Gaddah,
Ramon Roozendaal, Kerstin Luhn, Stephan
Bart, Macaya Douoguih. Anamnestic response after antigen
re-exposure following Ebola vaccine regimen with Ad26.ZEBOV and
MVA-BN-Filo in a phase I study - ECCMID Live.
https://www.eccmidlive.org/#!resources/anamnestic-response-after-antigen-re-exposure-following-ebola-vaccine-regimen-with-ad26-zebov-and-mva-bn-filo-in-a-phase-i-study.
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