NEW YORK and MAINZ, GERMANY, July 21,
2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:
BNTX) today announced the signing of a letter of intent with The
Biovac Institute (Pty) Ltd, known as “Biovac”, a Cape Town-based,
South African biopharmaceutical company, to manufacture the
Pfizer-BioNTech COVID-19 vaccine for distribution within the
African Union.
Biovac will perform manufacturing and
distribution activities within Pfizer’s and BioNTech’s global
COVID-19 vaccine supply chain and manufacturing network, which will
now span three continents and include more than 20 manufacturing
facilities. To facilitate Biovac’s involvement in the process,
technical transfer, on-site development and equipment installation
activities will begin immediately.
Pfizer and BioNTech expect that Biovac’s Cape
Town facility will be incorporated into the vaccine supply chain by
the end of 2021. Biovac will obtain drug substance from facilities
in Europe, and manufacturing of finished doses will commence in
2022. At full operational capacity, the annual production will
exceed 100 million finished doses annually. All doses will
exclusively be distributed within the 55 member states that make up
the African Union.
“From day one, our goal has been to provide fair
and equitable access of the Pfizer-BioNTech COVID-19 vaccine to
everyone, everywhere,” said Albert Bourla, Chairman and
Chief Executive Officer, Pfizer. “Our latest collaboration
with Biovac is a shining example of the tireless work being done,
in this instance to benefit Africa. We will continue to explore and
pursue opportunities to bring new partners into our supply chain
network, including in Latin America, to further accelerate access
of COVID-19 vaccines.”
“We aim to enable people on all continents to
manufacture and distribute our vaccine while ensuring the quality
of the manufacturing process and the doses,” said Ugur
Sahin, M.D., CEO and Co-founder of BioNTech. “We believe
that our mRNA technology can be used to develop vaccine candidates
addressing other diseases as well. This is why we will continue to
evaluate sustainable approaches that will support the development
and production of mRNA vaccines on the African continent.”
“We are thrilled to collaborate with Pfizer and
BioNTech to produce and distribute the Pfizer-BioNTech COVID-19
vaccine within Africa. This is testament of the long-standing
relationship we have had with Pfizer through the Prevenar 13
vaccine,” said Dr. Morena Makhoana, CEO of Biovac,
“This is a critical step forward in strengthening sustainable
access to a vaccine in the fight against this tragic, worldwide
pandemic. We believe this collaboration will create opportunity to
more broadly distribute vaccine doses to people in harder-to-reach
communities, especially those on the African continent.”
Pfizer and BioNTech select contract
manufacturers using a rigorous selection process based on several
factors: quality, compliance, safety track record, technical
capability, capacity availability, highly trained workforce,
project management abilities, prior working relationship, and
commitment to working with flexibility through a fast-paced
program. Pfizer and Biovac have worked together since 2015 on the
sterile formulation, fill, finish and distribution of the Prevenar
13 vaccine.
To date, Pfizer and BioNTech have shipped more
than 1 billion COVID-19 vaccine doses to more than 100 countries or
territories in every region of the world. The companies are firmly
committed to working towards equitable and affordable access for
COVID-19 vaccines for all people around the world, actively working
with global governments as well as global health partners with the
aim to provide 2 billion doses to low and middle income countries
in 2021 and 2022 – 1 billion each year. This includes an agreement
to supply 500 million doses to the U.S. Government at a
not-for-profit price, that the government will, in turn, donate to
the African Union and the COVAX 92 Advanced Market Commitment (AMC)
countries, as well as a direct supply agreement with the COVAX
facility for 40 million doses.
The Pfizer-BioNTech COVID-19 vaccine, which is
based on BioNTech’s proprietary mRNA technology, was developed by
both BioNTech and Pfizer. BioNTech is the Marketing Authorization
Holder in the European Union, and the holder of emergency use
authorizations or equivalent in the United States (jointly with
Pfizer), Canada and other countries in advance of a planned
application for full marketing authorizations in these
countries.
The Pfizer-BioNTech COVID-19 vaccine has not
been approved or licensed by the U.S. Food and Drug Administration
(FDA), but has been authorized for emergency use by FDA under an
Emergency Use Authorization (EUA) to prevent Coronavirus Disease
2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age
and older. The emergency use of this product is only authorized for
the duration of the declaration that circumstances exist justifying
the authorization of emergency use of the medical product under
Section 564 (b) (1) of the FD&C Act unless the declaration is
terminated or authorization revoked sooner. Please see Emergency
Use Authorization (EUA) Fact Sheet for Healthcare Providers
Administering Vaccine (Vaccination Providers) and Full EUA
Prescribing Information available at www.cvdvaccine-us.com.
AUTHORIZED USE IN THE U.S.: The
Pfizer-BioNTech COVID19 vaccine is authorized for use under an
Emergency Use Authorization (EUA) for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12
years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S.
FDA EMERGENCY USE AUTHORIZATION PRESCRIBING
INFORMATION:
- Do not administer Pfizer-BioNTech COVID-19 vaccine to
individuals with known history of a severe allergic reaction (eg,
anaphylaxis) to any component of the Pfizer-BioNTech COVID-19
vaccine
- Appropriate medical treatment used to manage immediate allergic
reactions must be immediately avai lable in the event an acute
anaphylactic reaction occurs following administration of
Pfizer-BioNTech COVID-19 vaccine
- Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the
occurrence of immediate adverse reactions according to the Centers
for Disease Control and Prevention guidelines
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html)
- Reports of adverse events following use of the Pfizer-BioNTech
COVID-19 Vaccine under EUA suggest increased risks of myocarditis
and pericarditis, particularly following the second dose. The
decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an
individual with a history of myocarditis or pericarditis should
take into account the individual’s clinical circumstances
- Syncope (fainting) may occur in association with administration
of injectable vaccines, in particular in adolescents. Procedures
should be in place to avoid injury from fainting
- Immunocompromised persons, including individuals receiving
immunosuppressant therapy, may have a diminished immune response to
the Pfizer-BioNTech COVID-19 Vaccine
- The Pfizer-BioNTech COVID-19 Vaccine may not protect all
vaccine recipients
- In clinical studies, adverse reactions in participants 16 years
of age and older included pain at the injection site (84.1%),
fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills
(31.9%), joint pain (23.6%), fever (14.2%), injection site swelling
(10.5%), injection site redness (9.5%), nausea (1.1%), malaise
(0.5%), and lymphadenopathy (0.3%)
- In a clinical study, adverse reactions in adolescents 12
through 15 years of age included pain at the injection site
(90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle
pain (42.2%), fever 3 (24.3%), joint pain (20.2%), injection site
swelling (9.2%), injection site redness (8.6%), lymphadenopathy
(0.8%), and nausea (0.4%)
- Following administration of the Pfizer-BioNTech COVID-19
Vaccine, the following have been reported outside of clinical
trials:
- severe allergic reactions, including anaphylaxis, and other
hypersensitivity reactions, diarrhea, vomiting, and pain in
extremity (arm)
- myocarditis and pericarditis
- Additional adverse reactions, some of which may be serious, may
become apparent with more widespread use of the Pfizer-BioNTech
COVID-19 Vaccine
- Available data on Pfizer-BioNTech COVID-19 Vaccine administered
to pregnant women are insufficient to inform vaccine-associated
risks in pregnancy
- Data are not available to assess the effects of Pfizer-BioNTech
COVID-19 Vaccine on the breastfed infant or on milk
production/excretion
- There are no data available on the interchangeability of the
Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to
complete the vaccination series. Individuals who have received one
dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second
dose of Pfizer-BioNTech COVID-19 Vaccine to complete the
vaccination series
- Vaccination providers must report Adverse Events in accordance
with the Fact Sheet to VAERS online at
https://vaers.hhs.gov/reportevent.html. For further assistance with
reporting to VAERS call 1-800-822-7967. The reports should include
the words “Pfizer- BioNTech COVID-19 Vaccine EUA” in the
description section of the report
- Vaccination providers should review the Fact Sheet for
Information to Provide to Vaccine Recipients/Caregivers and
Mandatory Requirements for Pfizer-BioNTech COVID- 19 Vaccine
Administration Under Emergency Use Authorization
- Before administration of Pfizer-BioNTech COVID-19 Vaccine,
please see Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers)
including Full EUA Prescribing Information available at
www.cvdvaccine-us.com
About Pfizer: Breakthroughs That Change
Patients’ LivesAt Pfizer, we apply science and our global
resources to bring therapies to people that extend and
significantly improve their lives. We strive to set the standard
for quality, safety and value in the discovery, development and
manufacture of health care products, including innovative medicines
and vaccines. Every day, Pfizer colleagues work across developed
and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 170 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.Pfizer.com. In
addition, to learn more, please visit us on www.Pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure NoticeThe
information contained in this release is as of July 21, 2021.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or
future events or developments.
This release contains forward-looking
information about Pfizer’s efforts to combat COVID-19, the
collaboration between BioNTech and Pfizer to develop a COVID-19
vaccine, the collaboration between BioNTech, Pfizer and Biovac to
manufacture and distribute COVID-19 vaccine doses within Africa,
the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19
Vaccine (BNT162b2) (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 the vaccine, the
anticipated timing of regulatory submissions, regulatory approvals
or authorizations and anticipated manufacturing, distribution and
supply) involving substantial risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statements. Risks and uncertainties include, among
other things, 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 (including the Phase 3 data), including the
possibility of unfavorable new preclinical, clinical or safety data
and further analyses of existing preclinical, clinical or safety
data; the ability to produce comparable clinical or other results,
including the rate of vaccine effectiveness and safety and
tolerability profile observed to date, in additional analyses of
the Phase 3 trial and additional studies or in larger, more diverse
populations following commercialization; the ability of BNT162b2 to
prevent COVID-19 caused by emerging virus variants; the risk that
more widespread use of the vaccine will lead to new information
about efficacy, safety, or other developments, including the risk
of additional adverse reactions, some of which may be serious; the
risk that preclinical and clinical trial data are subject to
differing interpretations and assessments, including during the
peer review/publication process, in the scientific community
generally, and by regulatory authorities; whether and when
additional data from the BNT162 mRNA vaccine program will be
published in scientific journal publications and, if so, when and
with what modifications and interpretations; whether regulatory
authorities will be satisfied with the design of and results from
these and any future preclinical and clinical studies; whether and
when other biologics license and/or emergency use authorization
applications or amendments to any such applications may be filed in
particular jurisdictions for BNT162b2 or any other potential
vaccines that may arise from the BNT162 program, and if obtained,
whether or when such emergency use authorization or licenses will
expire or terminate; whether and when any applications that may be
pending or filed for BNT162b2 (including the Biologics License
Application or any requested amendments to the emergency use or
conditional marketing authorizations) or other vaccines that may
result from the BNT162 program may be approved by particular
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the vaccine’s
benefits outweigh its known risks and determination of the
vaccine’s efficacy and, if approved, whether it will be
commercially successful; decisions by regulatory authorities
impacting labeling or marketing, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of a vaccine, including development of
products or therapies by other companies; disruptions in the
relationships between us and our collaboration partners, clinical
trial sites or third-party suppliers; the risk that demand for any
products may be reduced or no longer exist; risks related to the
availability of raw materials to manufacture a vaccine; challenges
related to our vaccine’s ultra-low temperature formulation,
two-dose schedule and attendant storage, distribution and
administration requirements, including risks related to storage and
handling after delivery by Pfizer; the risk that we may not be able
to successfully develop other vaccine formulations, booster doses
or new variant-specific vaccines; the risk that we may not be able
to create or scale up manufacturing capacity on a timely basis or
maintain access to logistics or supply channels commensurate with
global demand for our vaccine, which would negatively impact our
ability to supply the estimated numbers of doses of our vaccine
within the projected time periods as previously indicated; whether
and when additional supply agreements will be reached;
uncertainties regarding 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; challenges related to public vaccine
confidence or awareness; uncertainties regarding the impact of
COVID-19 on Pfizer’s business, operations and financial results;
and competitive developments.
A further description of risks and uncertainties
can be found in Pfizer’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2020 and in its subsequent reports on Form
10-Q, including in the sections thereof captioned “Risk Factors”
and “Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies 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 T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and 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 Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun
Pharma, and Pfizer. For more information, please visit
www.BioNTech.de.
BioNTech Forward-looking
Statements This press release contains “forward-looking
statements” of BioNTech within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, but may not be limited to, statements
concerning: BioNTech’s efforts to combat COVID-19; the
collaboration between BioNTech and Pfizer to develop a COVID-19
vaccine (including a potential second booster dose of BNT162b2
and/or a potential booster dose of a variation of BNT162b2 having a
modified mRNA sequence); our expectations regarding the potential
characteristics of BNT162b2 in our clinical trials and/or in
commercial use based on data observations to date; the ability of
BNT162b2 to prevent COVID-19 caused by emerging virus variants; the
expected time point for additional readouts on efficacy data of
BNT162b2 in our clinical trials; the nature of the clinical data,
which is subject to ongoing peer review, regulatory review and
market interpretation; the timing for submission of data for, or
receipt of, any marketing approval or Emergency Use Authorization;
our contemplated shipping and storage plan, including our estimated
product shelf life at various temperatures; and the ability of
BioNTech to supply the quantities of BNT162 to support clinical
development and market demand, including our production estimates
for 2021. Any forward-looking statements in this press release are
based on BioNTech 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
ability to meet the pre-defined endpoints in clinical trials;
competition to create a vaccine for COVID-19; the ability to
produce comparable clinical or other results, including our stated
rate of vaccine effectiveness and safety and tolerability profile
observed to date, in the remainder of the trial or in larger, more
diverse populations upon commercialization; the ability to
effectively scale our productions capabilities; and other potential
difficulties.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Annual Report as Form 20-F for the
Year Ended December 31, 2020, filed with the SEC on March 30, 2021,
which is available on the SEC’s website at www.sec.gov. All
information in this press release is as of the date of the release,
and BioNTech undertakes no duty to update this information unless
required by law.
About Biovac Biovac was
established in 2003 to revive local human vaccine production in
Southern Africa. Alongside the development of the local vaccine
industry, through steep investment in local skills and modern
facilities, the company has secured high profile technology
transfers from international pharmaceutical companies incuding
Pfizer and Sanofi Pasteur for the manufacturing of paediatric
vaccines. The company currently supplies a comprehensive range of
vaccines in support of the South African Department of Health’s
Expanded Programme for Immunisation. In addition to supplying
millions of doses of vaccines per year, across South Africa and
into some neighbouring countries, Biovac has been distributing
COVID19 vaccines in South Africa under various temperature
conditions, including minus 70degrees, minus 20 degrees and between
2 and 8 degrees. For more information, please visit:
www.biovac.co.za, our LinkedIn page and our Facebook page
@biovacSA.
Pfizer Contacts:Media
RelationsAmy Rose+1 (212) 733-7410Amy.Rose@pfizer.com Investor
RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:Media
RelationsJasmina Alatovic+49 (0)6131 9084 1513
Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084
1074Investors@biontech.de
Biovac Contacts:Media RelationsMichelle
Viljoen+27 21 514 5000media@biovac.co.za
BioNTech (NASDAQ:BNTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
BioNTech (NASDAQ:BNTX)
Historical Stock Chart
From Apr 2023 to Apr 2024