- Initial agreement provides up to 40 million doses to COVAX in
2021
- First deliveries are expected to take place in Q1 2021 subject
to the execution of supply agreements under the COVAX Facility
structure
- For the COVAX Advanced Market Commitment 92 countries, Pfizer
and BioNTech will provide the vaccine to COVAX at a not-for-profit
price.
Pfizer and BioNTech SE today announced an advance purchase
agreement with COVAX for up to 40 million doses of the
Pfizer-BioNTech COVID-19 Vaccine. The doses will be delivered
throughout 2021.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210122005366/en/
COVAX is a global initiative coordinated by the Global Alliance
for Vaccines and Immunization (GAVI), the Coalition for Epidemic
Preparedness Innovations (CEPI) and the World Health Organization
(WHO), to ensure equitable access to COVID-19 vaccines for all
countries, regardless of income levels. COVAX includes an Advanced
Market Commitment (AMC) financial mechanism that aims to ensure
that 92 low- and lower-middle-income countries will be able to
secure access to COVID-19 vaccines at the same time as
higher-income countries.
The first doses are expected to be delivered in the first
quarter of 2021, subject to the negotiation and execution of supply
agreements under the COVAX Facility structure.
For the COVAX Advanced Market Commitment 92 countries, Pfizer
and BioNTech will provide the vaccine to COVAX at a not-for-profit
price.
"At Pfizer, we believe that every person deserves to be seen,
heard and cared for. That's why from the very beginning of our
vaccine development program, Pfizer and BioNTech have been firmly
committed to working toward equitable and affordable access of
COVID-19 vaccines for people around the world," said Pfizer
Chairman & CEO Albert Bourla. "We share the mission of COVAX
and are proud to work together so that developing countries have
the same access as the rest of the world, which will bring us
another step closer to ending this global pandemic and proving that
Science Will Win for everyone, everywhere."
“SARS-CoV-2 does not differentiate between borders – a global
pandemic requires comprehensive solutions and worldwide
collaboration. COVAX is a truly global initiative and we are happy
to support by making BNT162b2 available in many low- and
lower-middle-income countries to help protect vulnerable people
worldwide,” said Ugur Sahin, M.D., CEO and Co-founder of
BioNTech.
“The urgent and equitable roll-out of vaccines is not just a
moral imperative, it is also a strategic and economic imperative,”
said Dr. Tedros Adhanom Ghebreyesus, Director-General of the World
Health Organization. "This agreement with Pfizer and BioNTech will
enable COVAX to save lives, stabilize health systems and drive the
global economic recovery.”
“Today marks another milestone for COVAX: in addition to
securing access to doses, we are now expecting the first deliveries
of life-saving COVID-19 vaccines in Q1. This is not just
significant for COVAX, it is a major step forward for equitable
access to vaccines, and an essential part of the global effort to
beat this pandemic. We will only be safe anywhere if we are safe
everywhere,” said Dr Seth Berkley, CEO of Gavi, the Vaccine
Alliance, which leads COVAX procurement and delivery.
As part of a broader strategy to support developing countries
beyond the agreement with COVAX, Pfizer and BioNTech are committed
to partnering with other global health stakeholders to provide
expertise and resources that can strengthen healthcare systems
where greater support may be needed to deploy COVID-19 vaccines.
This includes analyzing supply chains and piloting novel approaches
in low-income countries to address transportation and storage
challenges. Pfizer and BioNTech are also committed to coordinating
with international agencies to support supply and distribution in
refugee and other vulnerable populations.
Financial terms of the agreement were not disclosed.
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-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 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.sg 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 January 22,
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 potential COVID-19 vaccine, the BNT162 mRNA
vaccine program, an agreement with Singapore to supply BNT162 and
other potential agreements, and modRNA candidate 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 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
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 biologics license and/or emergency use
authorization applications may be filed in Singapore and any
particular jurisdictions for BNT162b2 or any other potential
vaccine candidates; whether and when any applications that may be
pending or filed for BNT162b2 may be approved by particular
regulatory authorities in Singapore, which will depend on myriad
factors, including making a determination as to whether the vaccine
candidate’s benefits outweigh its known risks and determination of
the vaccine candidate’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 candidate’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
any potential approved vaccine, which would negatively impact our
ability to supply the estimated numbers of doses of our vaccine
candidate 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 regarding a COVID-19 vaccine; our expectations regarding the
potential characteristics of BNT162b2 in our Phase 2/3 trial and/or
in commercial use based on data observations to date; the expected
time point for additional readouts on trial 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 estimate 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210122005366/en/
Pfizer Contacts:
Global Media Relations Contact Sharon Castillo +1
202.494.6769 Sharon.Castillo@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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