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.
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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 COVID-19 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 available 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’
Lives
At 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 Notice
The 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.
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Pfizer Contacts: Media Relations Amy Rose +1 (212)
733-7410 Amy.Rose@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts: Media Relations Jasmina Alatovic +49
(0)6131 9084 1513 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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