- U.S. government to purchase at not-for-profit price 200 million
doses in 2021 and 300 million in the first half of 2022
- Doses to be donated to approximately 100 low- and lower
middle-income countries including those in the African Union via
the COVAX Facility
- Effort is part of the companies’ recent pledge of two billion
doses to ensure global equitable access to the vaccine
NEW YORK and MAINZ, GERMANY, June 10,
2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX)
today announced plans to provide the U.S. government at a
not-for-profit price 500 million doses of the companies’ COVID-19
vaccine, 200 million doses in 2021 and 300 million doses in the
first half of 2022, to further support the multilateral efforts to
address the surge of infection in many parts of the world and to
help end the pandemic. The government will, in turn, donate the
Pfizer-BioNTech vaccine doses to low- and lower middle-income
countries and organizations that support them.
As part of the plan, the United States will
allocate the vaccine doses to 92 low- and lower middle-income
countries and economies as defined by Gavi’s COVAX Advance Market
Commitment (AMC) and the 55 member states of the African Union. The
U.S. government and the companies will work with COVAX to ensure
these vaccines are delivered to the specified countries around the
world in a way that is most efficient and equitable.
These doses are part of Pfizer and BioNTech’s
previously announced pledge to provide two billion doses of the
COVID-19 vaccine to low- and middle-income countries over the next
18 months.
“Our partnership with the U.S. government will
help bring hundreds of millions of doses of our vaccine to the
poorest countries around the world as quickly as possible. COVID-19
has impacted everyone, everywhere, and to win the battle against
this pandemic, we must ensure expedited access to vaccines for all.
I want to thank President Biden for his leadership in protecting
the least advantaged of our global neighbors,” said Albert
Bourla, Chairman and Chief Executive Officer, Pfizer. “Fair and
equitable distribution has been our North Star since Day One and we
are proud to do our part to help vaccinate the world, a massive but
an achievable undertaking.”
“As a vaccine developer, we felt the duty to
develop a well-tolerated and highly effective vaccine and make it
available to as many people worldwide as possible. Today’s
agreement underlines that the joint efforts of the private and the
public sector are providing solutions to help end this pandemic,”
said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “We
are also committed to realizing sustainable solutions by supporting
the establishment of manufacturing networks on various continents.
Our first step has been the establishment of our Regional
Headquarters for southeast Asia in Singapore which will also
include mRNA manufacturing capacities for regional and global
supply. It is our goal to leverage our proprietary mRNA technology
to help improve the health of people around the world.”
Deliveries of the 200 million doses will begin
in August 2021 and continue through the remainder of the year. The
300 million doses for 2022 will be delivered between January and
end of June 2022. The U.S. government also has the option for
additional doses in 2022. The plan is to produce the doses being
purchased by the U.S. government in Pfizer’s U.S. facilities. Those
U.S.-based sites involved in the production of the COVID-19 vaccine
include Kalamazoo, MI, Andover, MA, Chesterfield, MO, Groton, CT,
and McPherson, KS.
To date, Pfizer and BioNTech have shipped 700
million doses to more than 100 countries or territories around the
world. The companies have direct supply agreements in place with
122 countries and discussions are ongoing with many more on the
supply of the companies’ COVID-19 vaccine. Based on current
projections, Pfizer and BioNTech expect to manufacture up to 3
billion doses of the COVID-19 vaccine in 2021. The production
capacity has consistently grown due to continued enhancements to
the vaccine’s supply chain, which include expanding existing
facilities, adding more suppliers, and bringing on additional
Pfizer/BioNTech sites and contract manufacturers around the world
to produce the vaccine.
Pfizer and BioNTech have an existing agreement
in place to supply vaccine doses to the COVAX Facility, a mechanism
established by Gavi, the Vaccine Alliance, the Coalition for
Epidemic Preparedness Innovations (CEPI) and World Health
Organization (WHO) that aims to provide governments with early
access to a large portfolio of COVID-19 candidate vaccines using a
range of technology platforms, produced by multiple manufacturers
across the world. Pfizer-BioNTech doses allocated through COVAX
have reached people in every region of the world, including Rwanda,
South Korea, Colombia, Peru, Cabo Verde, Tunisia, Angola, West Bank
and the Gaza Strip, Moldova, El Salvador, Mongolia, the Maldives,
Bosnia and Herzegovina, Georgia, the Ukraine, Bolivia, Kosovo,
Bhutan, Bangladesh, Laos, Pakistan and the Philippines. Deliveries
to 47 countries and territories around the world are planned
through June 2021 as part of the COVAX second round allocation of
Pfizer-BioNTech COVID-19 vaccine doses.
Through both Pfizer and The Pfizer Foundation*,
a number of other innovative assistance efforts have been
supported, including:
- Working with International Rescue Committee and the Jordanian
Ministry of Health to provide essential primary health services and
vaccinations to refugees in Jordan;
- Collaborating with the UPS Foundation, which is donating
freezers to countries that need assistance with building out their
ultra-cold chain capacity; and
- Partnering with Zipline through funding and technical
expertise, to design and test a delivery solution that can safely
and effectively distribute all COVID-19 vaccines in difficult to
reach areas of the countries where it operates.
The U.S. government, the companies and COVAX
will finalize the plan and further operational details in the
coming weeks.
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 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 (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)
- 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%)
- Severe allergic reactions, including anaphylaxis, and other
hypersensitivity reactions, diarrhea, vomiting, and pain in
extremity (arm) have been reported following administration of the
Pfizer-BioNTech COVID-19 vaccine 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 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.
*The Pfizer Foundation is a charitable
organization established by Pfizer Inc. It is a separate legal
entity from Pfizer Inc. with distinct legal restrictions.
Pfizer Disclosure Notice The information
contained in this release is as of June 10, 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 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 the rolling
submission of a Biologics License Application for BNT162b2 in the
U.S. (the BLA) will be accepted for review 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 the BLA 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.
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
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