- U.S. government placed an initial order of 100 million doses
for $1.95 billion and can acquire up to 500 million additional
doses
- Americans to receive the vaccine for free consistent with U.S.
government’s commitment for free access for COVID-19 vaccines
- 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 potentially
more than 1.3 billion doses by the end of 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced the execution of an agreement with the U.S. Department of
Health and Human Services and the Department of Defense to meet the
U.S. government’s Operation Warp Speed program goal to begin
delivering 300 million doses of a vaccine for COVID-19 in 2021.
Under the agreement, the U.S. government will receive 100 million
doses of BNT162, the COVID-19 vaccine candidate jointly developed
by Pfizer and BioNTech, after Pfizer successfully manufactures and
obtains approval or emergency use authorization from U.S. Food and
Drug Administration (FDA).
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The U.S. government will pay the companies $1.95 billion upon
the receipt of the first 100 million doses, following FDA
authorization or approval. The U.S. government also can acquire up
to an additional 500 million doses.
Americans will receive the vaccine for free consistent with U.S.
government’s commitment for free access for COVID-19 vaccines.
“We’ve been committed to making the impossible possible by
working tirelessly to develop and produce in record time a safe and
effective vaccine to help bring an end to this global health
crisis,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We made
the early decision to begin clinical work and large-scale
manufacturing at our own risk to ensure that product would be
available immediately if our clinical trials prove successful and
an Emergency Use Authorization is granted. We are honored to be a
part of this effort to provide Americans access to protection from
this deadly virus.”
“Expanding Operation Warp Speed’s diverse portfolio by adding a
vaccine from Pfizer and BioNTech increases the odds that we will
have a safe, effective vaccine as soon as the end of this year,”
said HHS Secretary Alex Azar. “Depending on success in clinical
trials, today’s agreement will enable the delivery of approximately
100 million doses of this vaccine to the American people.”
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.
“We are pleased to have signed this important agreement with the
U.S. government to supply the initial 100 million doses upon
approval as part of our commitment to address the global health
threat. This agreement is one of many steps towards providing
global access to a safe and efficacious vaccines for COVID-19. We
are also in advanced discussions with multiple other government
bodies and we 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.
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 demonstrates 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. On July
20th, the companies announced early positive update from German
Phase 1/2 COVID-19 vaccine study, including first T Cell response
data.
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 Emergency Use 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 their clinical
trial.
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 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 22,
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 States to
manufacture and deliver BNT162 and other potential 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 future
production agreement with the United States 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/20200722005438/en/
Pfizer: 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: 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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