- 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
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.
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the full release here:
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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 south east 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
countries 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’
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.
*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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210609005930/en/
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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