NEW BRUNSWICK, N.J.,
Sept. 13, 2021 /PRNewswire/ -- Data
from two papers published in The Lancet Infectious
Diseases demonstrated that the Johnson & Johnson (the
Company) (NYSE: JNJ) Ebola vaccine regimen, Zabdeno®
(Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo), generated robust
humoral (antibody) immune responses in adults and children (ages
1-17) with the immune responses persisting in adults for at least
two years. The data also showed that booster vaccination with
Ad26.ZEBOV, administered to adults two years after the initial
vaccination, induced a strong anamnestic (immune) response within
seven days. These findings support the potential prophylactic use
of the vaccine regimen, which was developed by the Janssen
Pharmaceutical Companies of Johnson & Johnson (Janssen) in collaboration with Bavarian
Nordic A/S, and was granted Marketing Authorisation by the European
Commission in July 2020 and
Prequalification from the World Health Organization (WHO) in
April 2021.
The data is from the Phase 3 EBOVAC-Salone clinical study and
showed that the vaccine regimen was well-tolerated and induced
antibody responses to the Zaire
ebolavirus species 21 days after the second dose in 98 percent
of all participants. There were no safety signals of concern.
"These peer-reviewed data support the prophylactic use of the
Johnson & Johnson Ebola vaccine regimen to protect people at
risk of Ebola, which is essential to our vision of preventing Ebola
outbreaks before they can begin," said Paul
Stoffels, M.D., Vice Chairman of the Executive Committee and
Chief Scientific Officer of Johnson & Johnson. "Recent and
ongoing outbreaks in Africa
underscore that the threat of Ebola is not going away, which is why
we collaborated to develop a vaccine regimen capable of inducing
long-term immunity against Ebola and are now working to ensure that
it is accessible to people in need."
The EBOVAC-Salone study was conducted in Sierra Leone and is the first to assess the
safety and tolerability of the Johnson & Johnson Ebola vaccine
regimen in adults in a region affected by the 2014-2016 West
African Ebola outbreak, which was the worst on record. It is also
the first study evaluating the Johnson & Johnson Ebola vaccine
regimen in a randomized, double-blind, controlled trial in a
pediatric population.
Phase 3 Study Design (NCT02509494)
This Phase 3 study
was designed to gather information on the safety and immunogenicity
of the two-dose, heterologous (containing different vaccine
components administered at different timepoints) Johnson &
Johnson Ebola vaccine regimen. In this regimen, Ad26.ZEBOV was
administered intramuscularly as the first dose vaccination followed
56 days later by MVA-BN-Filo as the second dose vaccination.
The study was divided into two stages. In stage one, 43 adults
aged 18 years or older were vaccinated to gain information about
the safety and immunogenicity of the two-dose vaccine regimen. In
stage two, 400 adults and 576 children or adolescents (including
192 in each of the three age cohorts of 1-3, 4-11 and 12-17 years
of age) were vaccinated. Consenting adults participating in stage
one of the study were administered a booster dose of A26.ZEBOV two
years after the first dose.
The study was conducted at three clinics in Kambia District,
Sierra Leone. Long term follow-up
of the study participants is underway.
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.
The Company accelerated the development of its Ebola vaccine
regimen in 2014 in response to the 2014-2016 outbreak in
West Africa, which 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 UMURINZI campaign, which is
led by the Rwandan Ministry of Health, recently achieved its
endpoint of fully vaccinating 200,000 individuals against
Ebola.
In May 2021, Johnson & Johnson
announced it would donate thousands of Ebola vaccine regimens
in support of a WHO early access clinical program launched in
response to an outbreak in Guinea
and aimed at preventing Ebola in West
Africa. The program began by vaccinating health workers,
other frontline workers and others at increased risk of exposure to
the Ebola virus in Sierra
Leone.
In June 2021, Johnson &
Johnson welcomed a new recommendation by the Strategic
Advisory Group of Experts (SAGE) on Immunization for the WHO that
supports the use of the Johnson & Johnson Ebola vaccine regimen
both during outbreaks for individuals at some risk of Ebola
exposure, and preventively, in the absence of an outbreak, for
national and international first responders in neighboring areas or
countries where an outbreak might spread.
To date, more than 250,000 individuals participating in clinical
trials and vaccination initiatives have received at least the first
dose of the Johnson & Johnson Ebola vaccine regimen, including
200,000 who have been fully vaccinated.
Johnson & Johnson Ebola Vaccine Regimen
The European Commission-approved and World Health
Organization-Prequalified 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.
Janssen Research & Development, LLC is a member of the
Janssen Pharmaceutical Companies of Johnson & Johnson.
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/johnson--johnson-ebola-vaccine-regimen-demonstrated-robust-and-durable-immune-response-in-adults-and-children-in-data-published-in-the-lancet-infectious-diseases-301375740.html
SOURCE Johnson & Johnson