- In addition to today’s submission to the FDA, the companies
have already initiated rolling submissions across the globe
including in Australia, Canada, Europe, Japan and the U.K., and
plan to submit applications immediately to other regulatory
agencies around the world
- Based on current projections, the companies expect to produce
globally up to 50 million doses in 2020 and up to 1.3 billion doses
by the end of 2021; the companies will be ready to distribute the
vaccine within hours after authorization
- BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no
serious safety concerns observed to date
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.
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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 companies have 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.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 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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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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