- Thirty million doses expected to be delivered in 2020 and 2021,
subject to regulatory approval or authorization
- Pfizer and BioNTech remain on track to begin an anticipated
Phase 2b/3 safety and efficacy trial later this month, seek
regulatory review as early as October 2020 and manufacture globally
up to 100 million doses by the end of 2020 and more than 1.3
billion doses by the end of 2021
- Agreement is part of Pfizer’s and BioNTech’s global commitment
to help address the pandemic
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced an agreement with the United Kingdom to supply 30 million
doses of their BNT162 mRNA-based vaccine candidate against
SARS-CoV-2, currently in development, subject to clinical success
and regulatory approval. Financial details of the agreement were
not disclosed, but the terms were based on the timing of delivery
and the volume of doses.
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“In the face of this global health crisis, Pfizer’s purpose –
breakthroughs that change patients’ lives – has taken on an even
greater urgency. Consequently, we’re harnessing our scientific
expertise, and we’re marshaling our manufacturing resources to
ensure that the vaccine would be available as soon as possible, if
our clinical trials prove successful and regulatory approval is
granted,” said Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “This agreement is a testament to our shared goal to have
millions of doses of a vaccine against COVID-19 available before
the end of the year. We would like to thank the U.K. government for
its commitment and support in helping to protect the people of the
United Kingdom from this deadly virus.”
“I would like to thank the U.K. government for its support and
putting trust in us. This agreement is part of our commitment to
address the pandemic by creating a global supply. We are in
advanced discussions with multiple other government bodies and hope
to announce additional supply agreements soon. Our goal remains to
bring a safe and effective COVID-19 vaccine to many people around
the world, as quickly as we can,” said Ugur Sahin, M.D., CEO and
Co-founder of BioNTech.
“Finding a vaccine is one way that we will end the pandemic and
return to normal life. That is why we are making sure people most
at risk in the U.K. are vaccinated against COVID-19 as soon as a
safe vaccine becomes available, by partnering with the world’s
foremost pharmaceutical and vaccine companies,” said Alok Sharma,
the U.K.’s Secretary of State for Business, Energy and Industrial
Strategy.
The BNT162 program is based on BioNTech’s proprietary mRNA
technology and supported by Pfizer’s global vaccine development and
manufacturing capabilities. The BNT162 vaccine candidates are
undergoing clinical studies and are not currently approved for
distribution anywhere in the world. BioNTech is the market
authorization holder worldwide and will hold all trademarks for the
potential product. Both collaborators are committed to developing
these novel vaccines with pre-clinical and clinical data at the
forefront of all their decision-making.
The Pfizer/BioNTech vaccine development program is evaluating at
least four experimental vaccines, each of which represents a unique
combination of messenger RNA (mRNA) format and target antigen. On
July 1st, Pfizer and BioNTech announced preliminary data from
BNT162b1, the most advanced of the four mRNA formulations. The
early data demonstrate that BNT162b1 is able to produce
neutralizing antibodies in humans at or above the levels observed
in the plasma from patients who have recovered from COVID-19, and
this was shown at relatively low dose levels. Local reactions and
systemic events were dose-dependent, generally mild to moderate,
and transient. No serious adverse events were reported.
Recently, two of the companies’ four investigational vaccine
candidates (BNT162b1 and BNT162b2) received Fast Track designation
from the U.S. Food and Drug Administration (FDA). This designation
was granted based on preliminary data from Phase 1/2 studies that
are currently ongoing in the United States and Germany as well as
animal immunogenicity studies. Further data from the ongoing Phase
1/2 clinical trials of the four vaccine candidates will enable the
selection of a lead candidate and dose level for an anticipated
large, global Phase 2b/3 safety and efficacy study that may begin
as early as later this month, pending regulatory approval.
If the ongoing studies are successful, Pfizer and BioNTech
expect to be ready to seek Conditional Marketing Authorization or
some form of regulatory approval as early as October 2020. The
companies currently expect to manufacture globally up to 100
million doses by the end of 2020 and potentially more than 1.3
billion doses by the end of 2021, subject to final dose selection
from the clinical trial.
In addition to the 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 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.
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 July 20,
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 BNT162 mRNA vaccine program, a
collaboration between BioNTech and Pfizer to develop a potential
COVID-19 vaccine, an agreement with the United Kingdom to supply
BNT162 and other potential supply agreements, including their
potential benefits, manufacturing and distribution and the expected
timing of clinical trials and regulatory submissions, 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
the possibility of unfavorable new preclinical or clinical trial
data and further analyses of existing preclinical or clinical trial
data; risks associated with preliminary data; 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 applications may be filed in any
jurisdictions for any potential vaccine candidates under the
collaboration; 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
product’s benefits outweigh its known risks and determination of
the product’s efficacy and, if approved, whether any such vaccine
candidates 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 any such vaccine candidates, 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 United Kingdom will be reached; whether and when
other supply agreements will be reached; uncertainties regarding
the ability to obtain recommendations from vaccine technical
committees and other public health authorities regarding any such
vaccine candidates 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, 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; 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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version on businesswire.com: https://www.businesswire.com/news/home/20200719005057/en/
Pfizer Contacts: Media Relations Lisa O’Neill +44 or 0044
(0)7929 339 560 Lisa.O’neill@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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