- European Union orders 100 million additional doses of
COMIRNATY® bringing total doses to 300 million for 27 EU member
states
- All 300 million doses expected to be delivered in 2020 and
2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced they will supply an additional 100 million doses of
COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European
Union (EU) member states in 2021. This announcement is a result of
the European Commission’s decision to exercise its option to
purchase an additional 100 million doses under its Advanced
Purchase Agreement signed on November 11, 2020. This agreement
brings the total number of doses to be delivered to the EU to 300
million.
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“We remain committed to moving as quickly and safely as possible
to bring this vaccine to more people in Europe, as the deadly virus
continues to spread at an alarming rate,” said Albert Bourla,
Chairman and Chief Executive Officer, Pfizer. “In partnership
with the European Commission, member states and healthcare
providers, we will be able to reach a total of 150 million
Europeans across the continent.”
“The additional 100 million doses will be delivered in 2021
supporting the vaccination campaigns which started two days ago in
all 27 member states. Our goal remains to bring a safe and
effective COVID-19 vaccine to as many people as we can all around
the world,” said Ugur Sahin, M.D., CEO and Co-founder of
BioNTech.
COMIRNATY® will be produced in BioNTech’s and Pfizer’s
manufacturing sites in Europe. The distribution of COMIRNATY® by
the EU member states will continue to be determined according to
the populations identified in EU and national guidance. Pfizer and
BioNTech announced on November 11, 2020, that they reached an
agreement with the European Commission to supply 200 million doses,
with an option for the European Commission to request an additional
100 million doses. The companies previously stated their potential
to supply up to 1.3 billion doses worldwide by the end of 2021
(subject to manufacturing capacity).
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 150 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 December 29,
2020. 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 COMIRNATY®, the Pfizer-BioNTech COVID-19 Vaccine
(BNT162b2) (including qualitative assessments of available data,
potential benefits, expectations for clinical trials, an agreement
with the European Commission and the timing of delivery of doses
thereunder, the anticipated timing of regulatory submissions,
regulatory approval or authorization 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 clinical data (including the Phase 3 data), including the
possibility of unfavorable new preclinical or clinical trial data
and further analyses of existing preclinical or clinical trial
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 upon commercialization; 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
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; whether
regulatory authorities will be satisfied with the design of and
results from these and any future preclinical and clinical studies;
whether and when any other biologics license and/or emergency use
authorization applications may be filed in particular jurisdictions
for BNT162b2 or any other potential vaccines; whether and when any
applications that may be pending or filed for BNT162b2 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, 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 or third-party suppliers; risks related
to the availability of raw materials to manufacture a vaccine;
challenges related to our vaccine’s ultra-low temperature
formulation and attendant storage, distribution and administration
requirements, including risks related to handling after delivery by
Pfizer; the risk that we may not be able to successfully develop
non-frozen formulations; the risk that we may not be able to create
or scale up manufacturing capacity on a timely basis or have 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 indicated; whether and when additional supply
agreements will be reached; uncertainties regarding the ability to
obtain recommendations from vaccine technical committees and other
public health authorities and uncertainties regarding the
commercial impact of any such recommendations; 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, 2019 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 potential COVID-19 vaccine; our expectations
regarding the potential characteristics of BNT162b2 (COMIRNATY®) in
our Phase 2/3 trial and/or in commercial use based on data
observations to date; the expected timepoint for additional
readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; 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, if approved, market
demand, including our production estimates for 2020 and 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 Quarterly Report for the Three and Nine Months Ended
September 30, 2020, filed as Exhibit 99.2 to its Current Report on
Form 6-K filed with the SEC on November 10, 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 Andrew Widger +44 17373 30909
Eupress@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media Relations Jasmina Alatovic +49 89 62 81 75 46
Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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