BioNTech Achieves Milestone at mRNA-based Vaccine Manufacturing
Site in Rwanda
- Set-up of first BioNTainer as high-tech manufacturing solution
for mRNA medicines is a critical step in establishing a resilient
vaccine ecosystem in Africa and future pandemic preparedness
- BioNTech plans to complete all buildings at the Kigali site and
start local training of specialized personnel in the facility in
2024, with test mRNA production for process validation to be
initiated in 2025
- Upon successful validation, the Kigali facility will serve as a
lighthouse project for subsequent mRNA-based vaccine manufacturing
facilities of smaller or larger scale to support clinical
development or commercial-scale production in line with local or
regional demand
- In addition, BioNTech is progressing the development of mRNA
vaccine candidates for infectious diseases with high medical need,
including vaccine candidates against tuberculosis, malaria, and
HIV, as well as against infectious diseases with pandemic
potential, such as mpox. Upon successful development and approval,
these vaccines are intended for production at the newly established
site
- On invitation by H.E. President Paul Kagame of Rwanda, Heads of
State and Government from Africa and around the world, leadership
of the African Union and European Union, as well as from WHO,
Africa CDC and CEPI attended the official inauguration of the
BioNTech site in Kigali
KIGALI, Rwanda, December 18, 2023
(GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX,
“BioNTech” or “the Company”) has reached the next milestone in the
establishment of mRNA vaccine manufacturing capacities in Africa
with the inauguration of the Company’s site in Kigali, Rwanda. The
inauguration takes place on the occasion of the set-up of the first
manufacturing unit called BioNTainer. This effort is one of
BioNTech’s multiple initiatives aimed at helping to build a
sustainable and resilient African vaccine ecosystem and supporting
equitable access to novel medicines globally: these cover research
and development, clinical trials, manufacturing and local training
of specialized personnel.
At a whole-day conference titled “Working
together to promote vaccine equity for Africa” that preceded the
site inauguration, BioNTech engaged with representatives from the
World Health Organization (“WHO”), the Coalition for Epidemic
Preparedness Innovations (“CEPI”), Africa Centers for Disease
Control and Prevention (“Africa CDC”), Rwanda Food and Drug
Administration (“Rwanda FDA”), Health Emergency Preparedness and
Response Authority (“HERA”), the Bill and Melinda Gates Foundation
and the South African Health Products Regulatory Authority to
discuss opportunities and challenges in building a sustainable and
resilient vaccine ecosystem in Africa. Upon invitation by His
Excellency President Paul Kagame of Rwanda, Heads of State and
Government from around the world, highest leadership of the African
Union, European Union as well as from WHO and CEPI attended the
inauguration ceremony of BioNTech’s site. The Company’s
manufacturing site in Kigali could become the first
commercial-scale mRNA manufacturing facility on the continent.
The facility is based on the Company’s
high-tech, digitally enabled modular manufacturing units called
BioNTainers. They are designed to manufacture a range of mRNA-based
vaccines. The BioNTainers are also designed to be updated on a
regular basis, as BioNTech aims for them to remain one of the most
sophisticated mRNA manufacturing facilities in the world. The
manufacturing site will initially be equipped with two BioNTainers.
The containers for the first BioNTainer, which were recently set up
in the manufacturing hall and will serve to manufacture mRNA as
drug substance, arrived in Kigali in March 2023. The second
BioNTainer unit will serve to manufacture the formulated bulk drug
product and will be ready for shipment to the Rwanda site in the
first quarter of 2024.
The manufacturing facility in Kigali has been
fully funded by BioNTech to date. The Company has committed a total
investment of approximately USD 150 million to complete the
construction of the site including the manufacturing units. The
overall site has a size of approximately 35,000 square meters and
will have approximately 100 employees once fully operational. In
2024, BioNTech expects to complete all buildings on site, including
a warehouse, offices and laboratories for quality control. The
Company anticipates that, following local training of specialized
personnel in 2024, it can start operating with the manufacturing of
mRNA-based vaccine batches required for process validation in 2025.
The facility is intended to manufacture vaccines tailored to the
needs of African Union members. Its manufacturing capacity depends
on the mRNA product being manufactured and its various factors such
as dosage and formulation. For example, BioNTech could manufacture
up to 50 million doses annually of a product that has an RNA
process similar to that of the Pfizer-BioNTech COVID-19
Vaccine.
In line with the continent’s and partner
countries’ needs, BioNTech is committed to establishing additional
manufacturing facilities in Africa upon the successful validation
of the facility in Kigali, which serves as a lighthouse project.
Compared to the facility in Kigali, additional sites could be
designed as larger facilities providing increased commercial-scale
manufacturing capacities in Africa, or they could be smaller and
specialized in the manufacture of batches for the clinical
evaluation of product candidates.
To support the establishment of a sustainable
vaccine ecosystem in Africa, BioNTech is 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. Clinical trials for tuberculosis and malaria
vaccine programs are already underway in South Africa and the
United States, respectively. BioNTech plans to conduct clinical
trials in Africa for vaccine candidates against malaria,
tuberculosis and HIV in 2024. Malaria, tuberculosis and HIV are
highly prevalent in Africa, causing over two million deaths
annually, including a high degree of child mortality. If
successfully developed and authorized by regulatory authorities,
BioNTech plans to provide lower-income countries with access to the
four prophylactic vaccines at a not-for-profit price.
While in Kigali, Prof. Ugur Sahin, M.D., CEO and
Co-Founder of BioNTech, met with His Excellency Macky Sall,
President of the Republic of Senegal, and discussed developing a
potential research partnership between BioNTech and the Institut
Pasteur de Dakar with a focus on infectious diseases relevant to
the African continent.
Media materials of the inauguration of the site
are available under the following link which will be updated with
additional material subsequently:
https://www.biontech.com/int/en/home/newsroom.html
About the inauguration ceremony:
Attendees of the site inauguration ceremony included H.E. Paul
Kagame, President of the Republic of Rwanda, H.E. Macky Sall,
President of the Republic of Senegal, H.E. Nana Akufo-Addo,
President of the Republic of Ghana, Hon. Mia Amor Mottley,
Prime Minister of Barbados, H.E. Ursula von der Leyen,
President of the European Commission, African Union Chairperson
Moussa Faki Mahamat of the African Union Commission, Hon. Annalena
Baerbock, Federal Minister of Foreign Affairs of the Federal
Republic of Germany, Hon. Dr Mathume Joseph Phaala, Minister of
Health of the Republic of South Africa and Ambassador Gervais
Abayeho, Minister of East Africa Community Affairs of the Republic
of Burundi. In attendance from development finance institutions
were Dr Akinwumi Adesina, President of the African Development Bank
and European Investment Bank Vice President Gelsomina
Vigliotti.
Quotes given at the inauguration
ceremony:
H.E. Paul Kagame, President of the Republic
of Rwanda: “Vaccine inequity hit Africa hard during the
pandemic. But BioNTech’s partnership with Africa demonstrates that
vaccine technology can be democratized, so that Africa is ready and
resilient no matter what happens in the future.”
H.E. Macky Sall, President of the Republic of
Senegal: “This is a special day for Africa, BioNTech has taken
an important step towards greater vaccine equity. It is a
tremendous example of a company acting with great social
responsibility. I am fully supportive of what BioNTech is doing in
Rwanda and looking forward to progressing a research partnership in
Senegal with the Institute Pasteur in Dakar.”
H.E. Ursula von der Leyen, President of the
European Commission: “The opening of the first BioNTech Africa
site in Kigali is an important step towards African vaccine
sovereignty. Local manufacturing of vaccines with mRNA technology,
in Africa, for the African people, will be a game changer in the
fight against diseases and pandemics. The EU is proud to work with
Rwanda and BioNTech to develop a vibrant biopharmaceutical industry
on the continent. Global Gateway, Europe’s investment strategy,
invests in vaccine production in Africa and in the right skills,
jobs and capacities to spur health innovation at the scale of the
continent.”
African Union Chairperson Moussa Faki Mahamat
of the African Union Commission: “This is an important day for
Africa. The Continent is committed to increasing the accessibility
and quality of needed vaccines and other medicines to be available
to all Africans. That is also the purpose of the African Medicines
Agency, which has its headquarters here in Kigali. In this sense,
we believe this BioNTech facility and AMA will contribute to our
collective vision of a self-reliant Africa. Creating a high-quality
regulatory environment and ensuring vaccine independence is key to
our future capacity to prepare, respond and better recover from
pandemics. Working together to promote vaccine equity for Africa
remains our priority.”
Hon. Annalena Baerbock, Federal Minister of
Foreign Affairs of the Federal Republic of Germany: “The road
to a fair international health architecture is not a short-distance
race, but a team marathon. That is why Team Europe supports the
goal of Africa’s own vaccine production – from conception to
injection. Today, only one in 100 of the vaccine doses administered
in Africa is actually produced there; by 2040, this figure is set
to be 60 times higher. Global Gateway is making this possible by
providing 1.2 billion euro by 2027, with 550 million euro coming
from Germany alone. The opening of Africa’s first mRNA vaccine
factory in Rwanda by BioNTech is not yet the finishing line – but
it is a real milestone and a source of hope for millions.”
Dr. Jean Kaseya, Director-General, Africa
Centers for Disease Prevention and Control (Africa CDC): “The
local manufacturing agenda represents the second independence of
Africa, and the inauguration of the BioNTainer manufacturing
facility represents a significant milestone in our collective
efforts to strengthen vaccine production capabilities, enhance
health security, and improve access to life-saving vaccines across
the African continent.”
Prof. Ugur Sahin, M.D., CEO and Co-founder of
BioNTech: “We are committed to building a sustainable mRNA
vaccine ecosystem in Africa, focusing on the development of mRNA
vaccines against infectious diseases with high medical needs and
forging high-end technology solutions for local manufacturing.
Today's inauguration event establishing the first 'BioNTainer'
module for mRNA manufacturing is an important milestone in this
journey. Together with our partners, we are advancing towards our
first commercial scale mRNA facility in Africa, as a cornerstone of
our joint vision of a sustainable health future. I would like to
express my gratitude to our local and international partners for
their contributions to this joint effort, as well as to the entire
BioNTech team for their dedicated work which made this inauguration
possible.”
Sierk Poetting, Ph.D., Chief Operating
Officer of BioNTech: “The facility based on BioNTainers goes
beyond a mere physical structure. It represents the idea of
revolutionizing the manufacture of pharmaceuticals by combining
digital technology with standardized mRNA production. The
BioNTainers are designed to provide consistent manufacturing
processes that could be applied globally and could be tailored to
regional needs. We have set up the BioNTainers to be updated on a
regular basis with the aim to remain one of the most advanced mRNA
manufacturing facilities globally.”
About BioNTechBiopharmaceutical New
Technologies (BioNTech) is a next generation immunotherapy company
pioneering novel therapies for cancer and other serious diseases.
The Company 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 pharmaceutical collaborators, including Duality Biologics,
Fosun Pharma, Genentech, a member of the Roche Group, Genevant,
Genmab, OncoC4, Regeneron, Sanofi and Pfizer. For more information,
please visit www.BioNTech.com.
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 limited to,
statements concerning: the ability of BioNTech to produce, deliver
and install mRNA container manufacturing facilities for the African
continent, including the ability to meet all necessary
infrastructure, technology and regulatory requirements within
projected timelines; BioNTech’s plans to update the BioNTainers;
BioNTech’s ability to reach agreements with potential collaboration
partners in Africa, including a potential research partnership with
the Institut Pasteur de Dakar in Senegal; the development of
quality control capabilities; the scale-up of local know-how and
training in Africa; BioNTech’s malaria, tuberculosis, HIV, mpox and
other infectious disease vaccine development programs (including
qualitative assessments of available data, potential benefits,
expectations for clinical trials, supply agreements and the timing
of delivery of doses thereunder, efforts to help ensure global
equitable access to approved vaccines, the anticipated timing of
regulatory submissions, regulatory approvals or authorizations, and
anticipated manufacturing, distribution and supply); timing for
selecting clinical candidates for these programs and the
commencement of clinical trials, as well as any data readouts; the
nature of the collaboration with the African Union, the Africa CDC,
the WHO, and other parties; the development of sustainable RNA
vaccine capacities, production and supply solutions in Africa and
the nature, timing, and feasibility of these solutions. Any
forward-looking statements in this press release are based on
BioNTech’s current expectations and beliefs of future events, and
are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to: the potential
safety and efficacy of the product candidates; discussions with
regulatory agencies regarding timing and requirements for
additional clinical trials; the ability to produce comparable
clinical results in future clinical trials; potential delays in the
establishment of the BioNTainers and BioNTech operations in Africa
due to unforeseen developments, including, but not limited to,
global supply chain issues; and the rate and degree of market
acceptance of BioNTech’s investigational medicines, if
approved.
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 September 30, 2023 and in subsequent
filings made by BioNTech with the SEC, which are available on the
SEC’s website at https://www.sec.gov/. 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. These forward-looking statements are based on BioNTech’s
current expectations and speak only as of the date hereof.
CONTACTS
Investor RelationsVictoria Meissner, M.D.+1 617 528
8293Investors@biontech.de
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
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