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Johnson & Johnson Announces European Commission Approval for Janssen’s Preventive Ebola Vaccine

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Johnson & Johnson today announced that the
European Commission (EC) has granted Marketing Authorisation for its Janssen
Pharmaceutical Companies’ Ebola vaccine regimen for the prevention of Ebola Virus Disease.
Enabled by this approval, Janssen is now collaborating with the World Health Organization
(WHO) on vaccine pre-qualification, which should help accelerate registration of its
preventive Ebola vaccine regimen in African countries and facilitate broader access to those
most in need.

Two Marketing Authorisation Applications (MAAs) were submitted to the European Medicines
Agency (EMA) for the vaccines composing the two-dose regimen, Zabdeno® (Ad26.ZEBOV)
and Mvabea® (MVA-BN-Filo). Marketing Authorisation under exceptional circumstances has
been granted following Accelerated Assessment of the MAAs and a positive opinion by the
EMA’s Committee for Medicinal Products for Human Use (CHMP). Janssen’s Ebola vaccine
regimen is indicated for active immunization for the prevention of Ebola Virus Disease
caused by the Zaire ebolavirus species in individuals aged one year and above.
“The European approval of Janssen’s Ebola vaccine regimen is a landmark moment – both
for our Company and in the world’s battle against the deadly Ebola virus. Building on our
history, we are committed to bringing forward vaccines to help overcome the threat of some
of the world’s most life-threatening infectious diseases,” said Paul Stoffels, M.D., Vice
Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson.
The worst Ebola outbreak to date was the West African epidemic, which caused nearly
30,000 cases and more than 11,000 deaths in 2014-2016.

The world’s second worst Ebola
outbreak on record began in the Democratic Republic of the Congo (DRC), in 2018. It has
since caused more than 3,000 cases and over 2,000 deaths – a mortality rate of 65
percent.“The approval of our Ebola vaccine symbolizes the progress Janssen has made towards
achieving our vision of delivering potentially transformational vaccines to communities most
at risk of deadly infectious diseases. Not only is it the first vaccine to emerge from our
vaccines pipeline, it is also the first approved vaccine to be developed using Janssen’s
AdVac® technology.

The same technology is being used to develop vaccine candidates to
protect against SARS-CoV-2, as well as Zika, RSV and HIV,” said Mathai Mammen, M.D.,
Ph.D., Global Head, Janssen Research & Development, LLC.
Janssen’s Ebola vaccine regimen is specifically designed to induce long-term immunity
against the Ebola virus in adults and children aged one year and above. As such, it will be
used to support preventive vaccination in countries most at risk of outbreaks, as well as for
other at-risk groups such as healthcare workers, biosafety level 4 (BSL4) laboratory
workers, military personnel deployed in the affected regions, airport staff and visitors to
high-risk countries.

The regimen includes Ad26.ZEBOV as the first dose, based on Janssen’s AdVac® viral vector
technology,5 and MVA-BN-Filo as the second dose, based on Bavarian Nordic’s MVA-BN®
technology, administered approximately eight weeks later.6
“I am enormously grateful for the dedication from everyone who has been a part of this
development, including our many global strategic partners for their extraordinary
commitment to helping make this regimen a reality,” said Johan Van Hoof, M.D., Managing
Director, Janssen Vaccines and Prevention B.V. “The devastating 2014 outbreak of Ebola in
West Africa grew exponentially, overwhelming healthcare systems. In less than six years,
with the strength of global public-private collaborations, we have an approved Ebola vaccine
which could help those most in need, with the ultimate goal of preventing outbreaks before
they start.”

Janssen supported vaccination initiatives in the DRC and neighboring Rwanda, with the goal
of preventing Ebola’s geographic spread beyond the outbreak zone. When considering both
clinical studies and vaccination initiatives, approximately 60,000 people have been
vaccinated with Janssen’s preventive Ebola vaccine regimen to date.7
Janssen-sponsored Phase 1 studies have been reported in peer-reviewed journals including JAMA3,8 and the
Journal of Infectious Diseases,9,10 and Phase 1, 2 and 3 data were presented at the 2019
European Congress of Clinical Microbiology & Infectious Disease (ECCMID).4,6,11 These
studies indicate that the vaccine regimen is well tolerated, inducing robust and durable
immune responses to the Zaire ebolavirus species.

The evaluation of the protective effect of
the vaccine regimen was demonstrated through the bridging of clinical immunogenicity
results to efficacy and immunogenicity data obtained in non-human primates (NHP).12
In May 2019, the WHO’s Strategic Advisory Group of Experts (SAGE) on immunization
recommended the use of the Janssen Ebola vaccine regimen as part of efforts to contain the
DRC outbreak13 and more than 50,000 people in the DRC14 and Rwanda15 have been
vaccinated to date through this initiative alone.

Johnson & Johnson has made a significant investment in the Ebola vaccine regimen since its
decision to accelerate the development program in 2014 in response to the Ebola crisis in
West Africa. The Company is grateful to its global strategic partners who have helped to
support and co-fund these efforts, 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
program, and the National Institutes of Health (NIH) at the U.S. Department of Health and
Human Services (HHS).

Regulatory Submissions & Status
Today’s European Commission Marketing Authorisation decision follows the positive opinion
in May 2020 from the CHMP of the EMA
16 and the granting of an Accelerated Assessment for
Janssen’s investigational preventive Ebola vaccine regimen MAAs by the CHMP in September
2019.

The MAAs are supported by data from eleven Phase 1, 2 and 3 clinical studies18
evaluating the safety and immunogenicity (ability to induce an immune response) of the
vaccine regimen in more than 6,500 adults and children aged one year and above across
the U.S., Europe and Africa,18 preclinical studies, and immunobridging analyses comparing
the results of clinical and preclinical efficacy studies.
Discussions with the U.S. Food and Drug Administration (FDA) have taken place to define
the required data set for filing US licensure.

About Janssen’s Ebola Vaccine Regimen
The Janssen preventive Ebola vaccine regimen, Ad26.ZEBOV and 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.
Janssen’s 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,
College of Medicine and Allied Health Sciences (COMAHS, University of Sierra Leone),
Grameen Foundation, Inserm, Inserm Transfert, London School of Hygiene & Tropical
Medicine (LSHTM), Wellcome Trust, Coalition for Epidemic Preparedness Innovations (CEPI),
Uganda Virus Research Institute (UVRI), University of Antwerp, University of Oxford.

Université de Kinshasa (UNIKIN), Vibalogics GmbH, Walter Reed Army Institute of Research
(WRAIR), World Vision Ireland, The Ministry of Health and Sanitation Sierra Leone, Republic
of Rwanda Ministry of Health and the Democratic Republic of the Congo Ministry of Public
Health and all the people who participated in clinical trials during the Ebola epidemic in West
Africa and the DRC.

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.
Janssen Research & Development, LLC and Janssen Vaccines and Prevention B.V. are
members of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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.

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