Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic
Athletes at the 2020 Tokyo Games
NEW YORK and MAINZ, GERMANY, May 6, 2021—
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced the signing of a Memorandum of Understanding (MoU) with
the International Olympic Committee (IOC) to donate the companies’
COVID-19 vaccine to help vaccinate athletes, and their delegations,
participating in the Olympic and Paralympic Games Tokyo 2020, which
are scheduled to begin on July 23, 2021.
Under the MoU, the companies and the IOC will
coordinate with National Olympic Committees (NOCs) around the world
to understand and work to help address the local need for vaccine
doses for national delegations’ participation in the Games.
Delivery of initial doses to participating delegations is expected
to begin at the end of May where possible with the aim to ensure
participating delegations receive second doses ahead of arrivals in
Tokyo. Under the MoU framework, NOCs and their local governments
are expected to coordinate the administration of vaccinations to
eligible Games participants. Doses provided under this MoU would be
in addition to doses provided under supply agreements with
governments worldwide. The donation of vaccine doses will not
affect the supply of the national populations with COVID-19 doses
under the supply agreements.
“This donation of the vaccine is another tool in
our toolbox of measures to help make the Olympic and Paralympic
Games Tokyo 2020 safe and secure for all participants and to show
solidarity with our gracious Japanese hosts,” said IOC President
Thomas Bach. “We are inviting the athletes and participating
delegations of the upcoming Olympic and Paralympic Games to lead by
example and accept the vaccine where and when possible. By taking
the vaccine, they can send a powerful message that vaccination is
not only about personal health, but also about solidarity and
consideration of the wellbeing of others in their communities. We
would like to thank Pfizer and BioNTech for this very generous
donation to support the vaccination of athletes and Games
participants ahead of the Olympic and Paralympic Games Tokyo 2020,”
he added.
During a conversation between Albert Bourla,
Chairman and Chief Executive Officer, Pfizer, and Suga Yoshihide,
Prime Minister of Japan, which is the host country of Tokyo 2020,
Mr. Bourla made an offer to donate the Pfizer-BioNTech COVID-19
vaccine for athletes and their delegations participating in Tokyo
2020. Following this conversation, the Japanese government had a
meeting with the IOC and now the donation plan has been
realized.
“With hundreds of millions of vaccines already
administered, and hundreds of millions more to go, Pfizer is
committed, together with BioNTech, to doing all we can to help end
this pandemic and help return the world to a sense of normalcy,”
said Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “The return of the Olympic and Paralympic Games
represents a monumental moment of world unity and peace after a
grueling year of isolation and devastation. We are proud to play a
role in providing vaccines to athletes and national Olympic
delegations.”
“Providing vaccines to Games participants is one
of the critical ways to help ensure the Games are as safe and
successful as possible. With more than 430 million doses already
delivered, our vaccine continues to help protect lives around the
world and bring us back to our normal lives,” said Ugur Sahin,
M.D., CEO and Co-Founder of BioNTech. “This year’s Olympic and
Paralympic Games are an historic moment representing the global
community and how we stand together. We are honored to be able to
contribute vaccines to support the safety of the Olympic and
Paralympic Games.”
It is the decision of sovereign States to offer
immunization to athletes and their delegations in accordance with
their local guidance before travelling to Japan for the Tokyo
Games. The IOC and International Paralympic Committee (IPC) have
made it clear that vaccination is not mandatory in order for
athletes to participate in the Olympic and Paralympic Games, and
that any vaccination program must be conducted in full respect of
national vaccination priorities.
The Pfizer-BioNTech COVID-19 vaccine, which is
based on BioNTech 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), United Kingdom, 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) for use in individuals 16 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) including Full EUA
Prescribing Information available at www.cvdvaccine.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 16 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 (e.g., 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/).
- 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%).
- Severe allergic reactions have been
reported following
the Pfizer-BioNTech COVID-19 vaccine during mass
vaccination outside of clinical trials. 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
at https://vaers.hhs.gov/reportevent.html or by
calling 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.
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 May 6, 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 BNT162 mRNA vaccine program and the Pfizer-BioNTech
COVID-19 Vaccine (BNT162b2) (including qualitative assessments of
available data, potential benefits, expectations for clinical
trials, 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 a Biologics License Application for BNT162b2 may be filed in
the U.S. and 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 a potential Biologics License Application in the U.S. 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; 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.
Pfizer Contacts:
Media RelationsAmy Rose+1 (212) 733-7410
Amy.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
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