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).
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, Chairman and CEO,
Pfizer. “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’ LivesAt 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 NoticeThe
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 BioNTechBiopharmaceutical
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
statementsThis 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 to supply the United States with
additional doses of our vaccine under the U.S. government’s option
to purchase additional doses; 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.
Pfizer Contacts:
Media RelationsAmy Rose+1 (212)
733-7410Amy.Rose@pfizer.com
Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513 or +49 (0)151 1978 1385Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
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