Dose deliveries for new order expected to occur
from October 2021 through April 2022
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced that the U.S. government has purchased an additional 200
million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses
are expected to be delivered from October 2021 through April 2022.
This brings the total number of doses to be supplied by the
companies to the U.S. government under its existing supply
agreement to 500 million. In a separate announcement on June 10,
2021, Pfizer and BioNTech shared plans to provide the U.S.
government with 500 million doses of the companies’ COVID-19
vaccine for donation to the world’s poorest nations.
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the full release here:
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“As a long-term partner to the U.S. government in the fight
against this pandemic, we are proud of the impact of vaccination
efforts across the country. Vaccines have been and will remain
critical to protecting lives against this devastating disease,”
said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.
“These additional doses will help the U.S. government ensure broad
vaccine access into next year.”
“It has been our consistent goal to supply as many doses of our
COVID-19 vaccine as possible to people around the world to help
bring an end to this pandemic,” said Ugur Sahin, M.D., CEO and
Co-founder of BioNTech. “We are honored to support the U.S. and
more than 100 countries in their continuing vaccination
programs.”
The companies expect to deliver 110 million of the additional
doses by December 31, 2021, with the remaining 90 million doses to
be delivered no later than April 30, 2022. The U.S. government also
has the option to acquire an updated version of the vaccine to
address potential variants as well as new formulations of the
vaccine, if available and authorized.
Eligible U.S. residents will continue to receive the vaccine for
free, consistent with the U.S. government’s commitment for free
access to COVID-19 vaccines.
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), 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 (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/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 (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 23,
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, supply to the U.S.
government and the timing of delivery of doses thereunder, 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 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, 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)
733-1226 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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