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November 20, 2020
NEW YORK &
MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE:
PFE) and BioNTech SE (Nasdaq:
BNTX) announced they will submit a request today to the U.S. Food and Drug
Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA
vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially
enable use of the vaccine in high-risk populations in the U.S. by the
middle to end of December 2020.
The submission is
based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the
companies’ Phase 3 clinical study in participants without prior SARS-CoV-2
infection (first primary objective) and also in participants with and
without prior SARS-CoV-2 infection (second primary objective), in each case
measured from 7 days after the second dose. The first primary objective
analysis was based on 170 confirmed cases of COVID-19. This submission also
is supported by solicited safety data from a randomized subset of
approximately 8,000 participants ≥18 years of age and unsolicited safety
data from approximately 38,000 trial participants who have been followed
for a median of two months following the second dose of the vaccine
candidate. The submission also includes solicited safety data on
approximately 100 children 12-15 years of age. Approximately 42% of global
participants and 30% of U.S. participants in the Phase 3 study have
racially and ethnically diverse backgrounds, and 41% of global and 45% of
U.S. participants are 56-85 years of age. To date, the Data Monitoring
Committee (DMC) for the study has not reported any serious safety concerns
related to the vaccine.
“Our work to deliver
a safe and effective vaccine has never been more urgent, as we continue to
see an alarming rise in the number of cases of COVID-19 globally. Filing in
the U.S. represents a critical milestone in our journey to deliver a
COVID-19 vaccine to the world and we now have a more complete picture of
both the efficacy and safety profile of our vaccine, giving us confidence
in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We
look forward to the upcoming Vaccines and Related Biological Products
Advisory Committee discussion and continue to work closely with the FDA and
regulatory authorities worldwide to secure authorization of our vaccine
candidate as quickly as possible.”
“Filing for
Emergency Use Authorization in the U.S. is a critical step in making our
vaccine candidate available to the global population as quickly as
possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We
intend to continue to work with regulatory agencies worldwide to enable the
rapid distribution of our vaccine globally. As a company located in Germany
in the heart of Europe, our interactions with the European Medicines Agency
(EMA) are of particular importance to us and we have continuously provided
data to them as part of our rolling review process.”
The companieshave
already initiated rolling submissions with several regulatory agencies
around the world, including the EMA and the Medicines & Healthcare
Products Regulatory Agency (MHRA) in the United Kingdom, and intend to
submit applications to other regulatory agencies worldwide in the coming
days. In some cases, governments may have regulatory pathways similar to an
EUA. The companies will be ready to distribute the vaccine candidate within
hours after authorization.
Pfizer and BioNTech
are extremely grateful to the study volunteers and investigative site staff
in the clinical trial program, as their involvement was crucial to today’s
important milestone in the companies’ efforts to address the COVID-19
global pandemic.
The BNT162b2 vaccine
candidate is not currently approved for distribution anywhere in the world.
Both collaborators are committed to developing this novel vaccine with
preclinical and clinical data at the forefront of all their decision
making.
Manufacturing and
Delivery Capabilities
While Pfizer and
BioNTech await potential authorization or approval from regulatory
agencies, the companies continue to work in collaboration with governments
and Ministries of Health around the world that will distribute the vaccine,
subject to authorization or approval, to help ensure it can reach those
most in need as quickly as possible.
Pfizer is bringing
its leading in-house manufacturing capabilities to this effort, with the
ability and experience to quickly scale, manufacture and distribute large
quantities of vaccine at high quality, leveraging multiple sites in the
U.S. and Europe, and complementing the mRNA manufacturing expertise of
BioNTech, gained over almost a decade. Pfizer and BioNTech’s combined manufacturing
network has the potential to supply up to 50 million vaccine doses globally
in 2020 and up to 1.3 billion doses by the end of 2021 (subject to clinical
success, manufacturing capacity, and regulatory approval or authorization).
Pfizer has vast
experience and expertise in cold-chain shipping and has an established
infrastructure to supply the vaccine worldwide, including distribution hubs
that can store vaccine doses for up to six months. The company has
developed specially designed, temperature-controlled shippers for the
BNT162b2 vaccine candidate, which can maintain recommended storage
conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled
thermal sensor to track the location and temperature of each vaccine
shipment. Once thawed, the vaccine vial can be stored for up to 5 days at
refrigerated (2 - 8oC) conditions.
From the start of
the research program earlier this year, Pfizer and BioNTech have
successfully supplied and distributed their investigational vaccine to more
than 150 clinical trial sites across the U.S., as well as Europe, Latin
America, and South Africa. Based on their collective experience, the
companies believe in their capability to distribute the vaccine globally
upon approval or authorization.
About the Study
The Phase 3 clinical
trial of BNT162b2, which is based on BioNTech's proprietary mRNA
technology, began on July 27 and has enrolled 43,661 participants to date,
41,135 of whom have received a second dose of the vaccine candidate as of
November 13, 2020. A breakdown of the diversity of clinical trial
participants can be found here from approximately 150 clinical trials sites in
the U.S., Germany, Turkey, South Africa, Brazil and Argentina. Participants
will continue to be monitored for long-term protection and safety for an
additional two years after their second dose.
Pfizer and BioNTech
plan to submit the efficacy and safety data from the study for peer-review
in a scientific journal once analysis of the data is completed.
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 November 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 collaboration between BioNTech and Pfizer to develop a
potential COVID-19 vaccine, the BNT162 mRNA vaccine program and modRNA
candidate BNT162b2 (including qualitative assessments of available data,
potential benefits, expectations for clinical trials, the submission of a
request for Emergency Use Authorization and other regulatory submissions,
the anticipated timing of regulatory submissions, regulatory approval or
authorization and anticipated manufacturing, distribution and supply), 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 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 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 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 other 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; 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.govand 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 to develop a potential 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
timepoint for additional readouts on efficacy 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; the timing for submission of manufacturing data to the
FDA; our contemplated shipping and storage plan, including our estimated
product shelflife 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 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: 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.
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