BioNTech and CEPI Expand Partnership to Strengthen Africa’s mRNA
Vaccine Ecosystem
- BioNTech and CEPI aim to
enhance local R&D, clinical and commercial-scale manufacturing
capacities to develop potential mRNA vaccines in Africa, for
Africa
- CEPI to fund up to $145 million
to support BioNTech in broadening the scope of the manufacturing
facility in Kigali, Rwanda, aimed at addressing needs of African
countries and in compliance with global standards
- Partnership intends to
contribute to building a sustainable and resilient end-to-end
African vaccine ecosystem
- BioNTech and CEPI commit to
contributing to enabling equitable access, including affordable
pricing to select vaccines made at the facility for LMICs, with
priority access to African countries, and committed capacity to
manufacture emergency response vaccines
MAINZ, Germany/OSLO, Norway, May 29,
2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech”, “the
Company”) and the Coalition for Epidemic Preparedness Innovations
(“CEPI”) are expanding their strategic partnership to contribute to
building a sustainable and resilient end-to-end African vaccine
ecosystem. CEPI is committing up to US $145 million1 to
support BioNTech to establish mRNA vaccine R&D, clinical and
commercial-scale manufacturing capabilities at the Company’s
facility in Kigali, Rwanda. These capabilities will contribute to
efforts to better prepare for potential future epidemic and
pandemic threats in Africa.
BioNTech’s commercial-scale manufacturing
facility in Kigali was first announced in 2021 and inaugurated in
December 2023. The facility is based on the Company’s high-tech,
digitally enabled modular manufacturing units called BioNTainers,
designed to manufacture a range of mRNA-based vaccines. BioNTech’s
Kigali manufacturing facility could become the first commercial
mRNA facility in Africa, intended to support the African Union’s
and Africa CDC’s goal of producing 60 percent of total vaccine
doses required on the continent by 2040.
BioNTech and CEPI are committed to enabling
equitable access. Under the terms of the agreement BioNTech intends
to provide affordable access to BioNTech’s prophylactic vaccines
manufactured at the Kigali facility, such as vaccines against
malaria, mpox and tuberculosis, to low and middle-income countries,
with priority supply to African countries, if successfully
developed and authorized. BioNTech and CEPI intend to work jointly
to rapidly respond to outbreaks on the African continent caused by
known viral threats, or an as-yet-unknown pathogen with epidemic or
pandemic potential.
The BioNTech-CEPI partnership aims to back the
Company’s existing efforts in three key areas for Africa’s pandemic
preparedness and vaccine ecosystem:
- Commercial-scale
manufacturing: CEPI’s funding will support measures required
for the regulatory authorization of the facility in Rwanda,
starting in 2025. Under the terms of the agreement, in the event of
a disease outbreak or a potential disease outbreak, BioNTech, would
dedicate up to half of the facility’s manufacturing capacity to
produce emergency response mRNA vaccines, subject to regulatory
authorization. This effort aims to contribute to the 100 Days
Mission, a global initiative to accelerate the development of safe
and effective vaccines in response to an outbreak of a novel
Disease X in as little as 100 days. The 100 Days Mission is
spearheaded by CEPI and embraced by the G7, G20 and industry
leaders.
-
End-to-end clinical-scale manufacturing of novel
vaccine candidates: The majority of the CEPI funding
will be allocated to set up clinical-scale manufacturing
capabilities for mRNA-based vaccine candidates at the Kigali
facility. This will allow the BioNTech facility to manufacture on
both a clinical and commercial scale, and thus broaden the
manufacturing scope, in support of a sustainable use case for the
facility while strengthening the wider African vaccine development
ecosystem.
BioNTech is separately progressing the development of prophylactic
mRNA vaccines targeting infectious diseases such as tuberculosis,
malaria, and HIV, and is also focusing on diseases with epidemic
and pandemic potential, including mpox (supported by CEPI funding).
Clinical trials for tuberculosis, malaria and mpox vaccine programs
are underway in Europe, the United States, and South Africa. In
addition, BioNTech aims to conduct clinical trials in Africa for
vaccine candidates against malaria, HIV, and mpox.
-
Strengthening the African R&D ecosystem for mRNA-based
vaccines: CEPI’s funding will enable BioNTech to dedicate
manufacturing capacities to third party projects with the aim of
supporting, pre-clinical and clinical activities, including those
by African-based researchers, academic groups, local businesses,
public-private partnerships and non-profit
organizations2. The projects shall be selected in
partnership with global, regional and national healthcare
organizations. This effort by BioNTech and CEPI has the potential
to enable R&D activities for novel mRNA-based vaccine
candidates against pathogens with epidemic or pandemic
potential.
“Africa still has to import 99 percent of all
the vaccines it needs to protect its people from potentially deadly
diseases, meaning many are left waiting far too long to get the
life-saving doses they need. This must change if the world is going
to avoid the terrible inequity of vaccine distribution that so
clearly exacerbated the effects of the COVID-19 pandemic. Through
our joint commitment to equitable access, CEPI’s investment in
BioNTech’s forward-looking efforts in Africa will boost regional
capacity for end-to-end research, development and rapid
manufacturing of mRNA vaccines. This will contribute to Africa’s
resilience and pandemic readiness and could dramatically alter the
course of future outbreaks,” said Dr. Richard Hatchett, CEO of
the Coalition for Epidemic Preparedness Innovations (CEPI).
Our partnership with CEPI is an important next
step in our comprehensive strategy towards sustainable mRNA vaccine
manufacturing in Africa. Our joint efforts are strengthening the
implementation of a local mRNA vaccine ecosystem - covering the
entire spectrum from research and clinical trials to commercial
production,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of
BioNTech. "This, along with our continued efforts to develop
mRNA vaccines against diseases like tuberculosis, malaria, HIV, and
mpox is aimed at bringing lasting health benefits to millions of
people in Africa.
BioNTech and CEPI first announced their strategic partnership in
September 2023.
The following parties, which are not
contractually involved in this strategic partnership, indicated
their support:
Dr. Sabin Nsanzimana, Minister of Health,
Republic of Rwanda: “The Government of Rwanda is committed to
tackling vaccine inequities that were exposed during the pandemic.
We believe this innovative partnership we are building can be a
demonstration to the world, that Africa is not only building
resilience for future pandemics but also creating a sustainable
clinical ecosystem across Africa using the most advanced mRNA
technology. The power of partnership is what will make this project
successful, and today is another great milestone towards creating
vaccine equity.”
H.E. Dr. Jean Kaseya, Director General of
Africa Centres for Disease Control (Africa CDC), said: “Rapid
and equitable access to life-saving vaccines starts with local
development and manufacturing. CEPI and BioNTech’s joint endeavor
in Rwanda will contribute to Africa's R&D ecosystem and support
Africa CDC's Platform for Harmonized African Health Products
Manufacturing (PHAHM)’s goal to produce 60 percent of the vaccines
needed by the continent by 2040. Working together, we can pave the
way to strengthen Africa’s pandemic preparedness and health
security.”
Dr. Tedros Adhanom Ghebreyesus, WHO
Director-General: “The COVID-19 pandemic exposed the risks to
global health when production of vaccines and other tools is
concentrated in too few hands. Strengthening local and regional
production, especially in Africa and the Middle East, is critical
for ensuring a more equitable response to future epidemics and
pandemics, and for fighting other persistent health challenges.
Public-private partnerships like this are part of a growing global
movement, bringing together companies, foundations and countries to
diversify production and make the world a safer place. This is an
important day for Rwanda and Africa and should act as a
steppingstone for further countries and parties to come
together.”
About CEPI
CEPI was launched in 2017 as an innovative partnership between
public, private, philanthropic and civil organizations. Its mission
is to accelerate the development of vaccines and other biologic
countermeasures against epidemic and pandemic threats so they can
be accessible to all people in need. CEPI has supported the
development of more than 50 vaccine candidates or platform
technologies against multiple known high-risk pathogens or a future
Disease X. Central to CEPI’s pandemic-beating five-year plan for
2022-2026 is the ‘100 Days Mission’ to compress the time taken to
develop safe, effective, globally accessible vaccines against new
threats to just 100 days.
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next
generation immunotherapy company pioneering novel therapies for
cancer and other serious diseases. BioNTech exploits a wide array
of computational discovery and therapeutic drug platforms for the
rapid development of novel biopharmaceuticals. Its broad portfolio
of oncology product candidates includes individualized and
off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor (CAR) T cells, several protein-based therapeutics,
including bispecific immune checkpoint modulators, targeted cancer
antibodies and antibody-drug conjugate (ADC) therapeutics, as well
as small molecules. Based on its deep expertise in mRNA vaccine
development and in-house manufacturing capabilities, BioNTech and
its collaborators are developing multiple mRNA vaccine candidates
for a range of infectious diseases alongside its diverse oncology
pipeline. BioNTech has established a broad set of relationships
with multiple global and specialized pharmaceutical collaborators,
including Biotheus, DualityBio, Fosun Pharma, Genentech, a member
of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and
Regeneron.
BioNTech Forward-looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not be limited to, statements concerning:
BioNTech’s efforts to develop novel prophylactic vaccines for a
range of infectious diseases with high medical need; BioNTech’s
partnership with CEPI and BioNTech’s ability to receive up to $145
million in funding; BioNTech’s efforts to establish mRNA research
and development, clinical and commercial-scale manufacturing
capabilities at its facility in Kigali; BioNTech’s ongoing and
future planned clinical trials, including in Africa; and BioNTech’s
ability to develop and, if successfully developed and approved,
commercialize its vaccine candidates. In some cases,
forward-looking statements can be identified by terminology such as
“will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,”
“anticipates,” “believes,” “estimates,” “predicts,” “potential,”
“continue,” or the negative of these terms or other comparable
terminology, although not all forward-looking statements contain
these words.
The forward-looking statements in this press
release are based on BioNTech’s current expectations and beliefs of
future events, and are neither promises nor guarantees. You should
not place undue reliance on these forward-looking statements
because they involve known and unknown risks, uncertainties, and
other factors, many of which are beyond BioNTech’s control and
which could cause actual results to differ materially and adversely
from those expressed or implied by these forward-looking
statements. These risks and uncertainties include, but are not
limited to: the uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for clinical trials,
regulatory submission dates, regulatory approval dates and/or
launch dates, as well as risks associated with preclinical and
clinical data, and including the possibility of unfavorable new
preclinical, clinical or safety data and further analyses of
existing preclinical, clinical or safety data; the nature of
clinical data, which is subject to ongoing peer review, regulatory
review and market interpretation; the timing of and BioNTech’s
ability to obtain and maintain regulatory approval for its product
candidates; discussions with regulatory agencies regarding timing
and requirements for additional clinical trials; BioNTech’s and its
counterparties’ ability to manage and source necessary energy
resources; BioNTech’s ability to identify research opportunities
and discover and develop investigational medicines; the ability and
willingness of BioNTech’s third-party collaborators to continue
research and development activities relating to BioNTech’s
development candidates and investigational medicines; unforeseen
safety issues and potential claims that are alleged to arise from
the use of products and product candidates developed or
manufactured by BioNTech; BioNTech’s and its collaborators’ ability
to commercialize and market, if approved, its product candidates;
BioNTech’s ability to manage its development and expansion;
regulatory developments in the United States and other countries;
BioNTech’s ability to effectively scale BioNTech’s production
capabilities and manufacture BioNTech’s products and BioNTech’s
product candidates; risks relating to the global financial system
and markets; the future commercial demand and medical need for
mRNA-based products in Africa; the availability of raw materials to
manufacture a vaccine; competition from other products, including
those with different mechanisms of action and different
manufacturing and distribution constraints, on the basis of, among
other things, efficacy, cost, convenience of storage and
distribution, breadth of approved use, side-effect profile and
durability of immune response; the ability to obtain
recommendations from vaccine advisory or technical committees and
other public health authorities and uncertainties regarding the
commercial impact of any such recommendations; and other factors
not known to BioNTech at this time.
You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech’s Report on
Form 6-K for the period ended March 31, 2024 and in subsequent
filings made by BioNTech with the U.S. Securities and Exchange
Commission (“SEC”), which are available on the SEC’s website at
www.sec.gov. These forward-looking statements speak only as of the
date hereof. Except as required by law, BioNTech disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise.
Press Contact Details
CEPI
+44 7387 055214
press@cepi.net
BioNTech
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations
Victoria Meissner, M.D.
+1 617 528 8293
Investors@biontech.de
1contingent on pre-agreed activity milestones
2Projects must meet certain criteria and shall be
selected in partnership with global, regional and national
healthcare organizations.
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