- The proposed agreement is intended to provide a supply of 200
million doses and an option to purchase additional 100 million
doses, with deliveries starting by the end of 2020, subject to
regulatory approval
- The vaccine supply for the EU would be produced by BioNTech’s
manufacturing sites in Germany and Pfizer’s manufacturing site in
Belgium
- Pfizer and BioNTech are on track to seek regulatory review of
BNT162b2 as early as October 2020 and, if regulatory authorization
or approval is obtained, currently plan to supply up to 100 million
doses worldwide by the end of 2020 and approximately 1.3 billion
doses by the end of 2021
Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced that they had concluded exploratory talks with the
European Commission for a proposed supply of 200 million doses of
their investigational BNT162 mRNA-based vaccine candidate against
SARS-CoV-2 to European Union (EU) Member States, with an option for
further 100 million doses. Deliveries would be starting by the end
of 2020, subject to clinical success and regulatory authorization.
The companies will now enter into contract negotiations with the
European Commission.
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The proposed supply agreement with the European Commission would
represent the largest initial order of vaccine doses for Pfizer and
BioNTech to date. Vaccine doses for Europe would be produced in
BioNTech’s German manufacturing sites, as well as in Pfizer’s
manufacturing site in Belgium. If regulatory approval for the
BNT162b2 vaccine candidate is received, the European Commission
would lead the process for allocation of the vaccine doses among
the 27 EU Member States.
“Pfizer and BioNTech’s anticipated agreement with the European
Commission is an important step forward in our shared goal to have
millions of doses of a vaccine against COVID-19 available for
vulnerable populations before the end of the year. We would like to
thank the European Commission for its commitment and confidence in
our development efforts,” said Albert Bourla, Chairman and CEO,
Pfizer. “We have activated our supply chain, most importantly
our site in Belgium, and are starting to manufacture so that our
vaccine would be available as soon as possible, if our clinical
trials prove successful and regulatory approval is granted.”
“As a company founded in the heart of Europe, we are pleased to
have concluded exploratory discussions with the European
Commission, which would be our largest initial order to date. Our
aim is to develop a safe and effective vaccine to contribute to
bringing this pandemic to an end in Europe and across the world.
Today’s decision is a further illustration of how collaboration and
solidarity can help address a global health crisis as an
international community,” said Ugur Sahin, M.D., CEO and
Co-founder of BioNTech.
In addition to engagements with governments, Pfizer and BioNTech
have provided an expression of interest for possible supply 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, using a range of
technology platforms, aims to provide governments, including those
in the emerging markets, with early access to a large portfolio of
COVID-19 candidate vaccines produced by multiple manufacturers
across the world.
About the BNT162 Vaccine Candidate Program
The BNT162 program is based on BioNTech’s proprietary mRNA
technology and supported by Pfizer’s global vaccine development and
manufacturing capabilities. Two of the companies’ four
investigational vaccine candidates – BNT162b1 and BNT162b2 –
received Fast Track designation from the U.S. Food and Drug
Administration (FDA), based on preliminary data from Phase 1/2
studies that are currently ongoing in the U.S. and Germany as well
as animal immunogenicity studies. During preclinical and clinical
studies, BNT162b1 and BNT162b2 emerged as strong candidates based
on assessments of safety and immune response.
On July 27, Pfizer and BioNTech announced that following
extensive review of preclinical and clinical data from Phase 1/2
clinical trials, and in consultation with the FDA’s Center for
Biologics Evaluation and Research (CBER) and other global
regulators, the companies selected the BNT162b2 vaccine candidate
to move forward into a Phase 2/3 study. BNT162b2 encodes an
optimized SARS-CoV-2 full-length spike glycoprotein (S), which is
the target of virus neutralizing antibodies.
About the Phase 2/3 Study
In the late-stage trial, Pfizer and BioNTech are studying a 30µg
dose level in a 2-dose regimen among up to 30,000 participants aged
18 to 85 years. The companies have selected approximately 120 sites
globally, including those in regions with significant expected
SARS-CoV-2 transmission, and are working to reach a diverse
population and enroll those volunteers at increased risk for the
infection with the virus. The Phase 2/3 trial enrollment to date
has exceeded 25,000 participants with a second dose underway.
Assuming clinical success, Pfizer and BioNTech are on track to seek
regulatory review for BNT162b2 as early as October 2020 and, if
regulatory authorization or approval is obtained, currently plan to
supply up to 100 million doses worldwide by the end of 2020 and
approximately 1.3 billion doses by the end of 2021. To meet those
anticipated quantities and milestones, the companies have produced
sufficient supply for their 30,000 participant Phase 2/3 clinical
trial and have begun to produce and stockpile their pandemic
supply.
The BNT162 vaccine candidate is not currently approved for
distribution anywhere in the world. Both collaborators are
committed to developing these novel vaccines with preclinical and
clinical data at the forefront of all their decision making.
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 September 7,
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 potential COVID-19 vaccine, a potential
agreement with the European Commission to supply BNT162 and other
potential agreements, the BNT162 mRNA vaccine program, and modRNA
candidates BNT162b2 and BNT162b1 (including qualitative assessments
of available data, potential benefits, expectations for clinical
trials and timing of regulatory submissions, anticipated
manufacturing, supply and distribution), that involves 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 preliminary data, including the possibility of
unfavorable new preclinical or clinical trial data and further
analyses of existing preclinical or clinical trial data that may be
inconsistent with the data used for selection of the BNT162b2
vaccine candidate and dose level for the Phase 2/3 study; 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 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 future preclinical and clinical studies; whether and when
any biologics license and/or emergency use authorization
applications may be filed in any jurisdictions for BNT162b2 or any
other potential vaccine candidates; whether and when any such
applications may be approved by regulatory authorities, 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; manufacturing
capabilities or capacity, including whether the estimated numbers
of doses can be manufactured within the projected time periods
indicated; whether and when a definitive supply agreement with the
European Commission will be reached; 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; 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 timing to initiate clinical trials
of BNT162 and anticipated publication of data from these clinical
trials; the timing for any potential emergency use authorizations
or approvals; our expectation to agree to final terms with and
enter into a definitive agreement with the European Commission; the
potential to enter into additional supply agreements with other
jurisdictions or the COVAX Facility; the potential safety and
efficacy of BNT162; the collaboration between BioNTech and Pfizer
to develop a potential COVID-19 vaccine; 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: competition to
create a vaccine for COVID-19; the ability to produce comparable
clinical results in larger and more diverse clinical trials; 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 on Form 20-F
filed with the SEC on March 31, 2020, 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 Andy Widger +44 7970 149098
andrew.widger@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 or
+49 (0)151 1978 1385 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084
1074 Investors@biontech.de
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